Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. Desloratadine oral solution is indicated for the symptomatic relief of pruritus, reduction in t...
Desloratadine oral solution may be taken without regard to meals. The age-appropriate dose of desloratadine oral solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoonful). The recommended dose of desloratadine oral solution is 2 teaspoonfuls (5 mg in 10 mL) once daily. The recommended dose of desloratadine oral solution ...
Desloratadine oral solution is a clear, pink to light pink colored solution with characteristic bubble gum odor containing 0.5 mg/mL desloratadine and is available in the following sizes: 4 fl oz (118 mL) NDC 51672-4159-8, 6 fl oz (177 mL) NDC 51672-4159-5, 8 fl oz (237 mL) NDC 51672-4159-1. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
www.fda.gov/medwatchDesloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.
Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.
Desloratadine oral solution is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.
Desloratadine oral solution may be taken without regard to meals. The age-appropriate dose of desloratadine oral solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoonful).
The recommended dose of desloratadine oral solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
The recommended dose of desloratadine oral solution is 1 teaspoonful (2.5 mg in 5 mL) once daily.
The recommended dose of desloratadine oral solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.
The recommended dose of desloratadine oral solution is 2 mL (1 mg) once daily.
Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Desloratadine oral solution is a clear, pink to light pink colored solution containing 0.5 mg desloratadine /mL
Desloratadine oral solution is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)].
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine. If such a reaction occurs, therapy with desloratadine should be stopped and alternative treatment should be considered. [See Adverse Reactions (6.2).] This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
The following adverse reactions are discussed in greater detail in other sections of the label:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adults and Adolescents
Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received desloratadine tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the desloratadine group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of desloratadine tablets (5 mg once daily), and that were more common with desloratadine tablets than placebo, are listed in Table 1.
| Adverse Event | Desloratadine Tablets 5 mg (n = 1655) | Placebo (n = 1652) |
|---|---|---|
| Infections and Infestations | 4.1% | 2.0% |
| Pharyngitis | ||
| Nervous System Disorders | 2.1% | 1.8% |
| Somnolence | ||
| Gastrointestinal Disorders | 3.0% | 1.9% |
| Dry Mouth | ||
| Musculoskeletal and Connective Tissue Disorders | 2.1% | 1.8% |
| Myalgia | ||
| Reproductive System and Breast Disorders | 2.1% | 1.6% |
| Dysmenorrhea | ||
| General Disorders and Administration Site Conditions | 2.1% | 1.2% |
| Fatigue |
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received desloratadine tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received desloratadine tablets and that were more common with desloratadine than placebo were (rates for desloratadine and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).
Pediatrics
Two hundred and forty-six pediatric subjects 6 months to 11 years of age received desloratadine oral solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.
In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.
In subjects 2 to 5 years of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving desloratadine oral solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).
In subjects 12 months to 23 months of age, adverse events reported for the desloratadine product and placebo in at least 2 percent of subjects receiving desloratadine oral solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).
In subjects 6 months to 11 months of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving desloratadine oral solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).
There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving desloratadine oral solution in the clinical trials discontinued treatment because of an adverse event.
Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.
In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]
In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]
In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, desloratadine should be used during pregnancy only if clearly needed.
Desloratadine was not teratogenic in rats or rabbits at approximately 210 and 230 times, respectively, the area under the concentration-time curve (AUC) in humans at the recommended daily oral dose. An increase in pre-implantation loss and a decreased number of implantations and fetuses were noted, however, in a separate study in female rats at approximately 120 times the AUC in humans at the recommended daily oral dose. Reduced body weight and slow righting reflex were reported in pups at approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. Desloratadine had no effect on pup development at approximately 7 times the AUC in humans at the recommended daily oral dose. The AUCs in comparison referred to the desloratadine exposure in rabbits and the sum of desloratadine and its metabolites exposures in rats, respectively. [See Nonclinical Toxicology (13.2).]
Desloratadine passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.
The recommended dose of desloratadine oral solution in the pediatric population is based on cross-study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. The safety of desloratadine oral solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of desloratadine are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of desloratadine oral solution in these age groups is supported by evidence from adequate and well-controlled studies of desloratadine tablets in adults. The safety and effectiveness of desloratadine oral solution has not been demonstrated in pediatric patients less than 6 months of age. [See Clinical Pharmacology (12.3).]
Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. [See Clinical Pharmacology (12.3).]
Dosage adjustment for patients with renal impairment is recommended [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].
Dosage adjustment for patients with hepatic impairment is recommended [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the desloratadine product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported.
In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of desloratadine 45 mg for 10 days [see Clinical Pharmacology (12.2)].
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated desloratadine exposures were approximately 290 times the human daily oral dose on a mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).
Desloratadine oral solution is a clear, pink to light pink solution containing 0.5 mg/mL desloratadine. It contains the following inactive ingredients: bubble gum flavor, citric acid anhydrous, D&C Red No. 33, noncrystallizing sorbitol solution (70%), propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, and sucrose.
Desloratadine is a white to beige powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:
Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro. Results of a radiolabeled tissue distribution study in rats and a radioligand H1-receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier. The clinical significance of this finding is unknown.
Wheal and Flare: Human histamine skin wheal studies following single and repeated 5-mg doses of desloratadine have shown that the drug exhibits an antihistaminic effect by 1 hour; this activity may persist for as long as 24 hours. There was no evidence of histamine-induced skin wheal tachyphylaxis within the desloratadine 5-mg group over the 28-day treatment period. The clinical relevance of histamine wheal skin testing is unknown.
Effects on QTc: Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. In desloratadine-treated subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo. The QT interval was corrected for heart rate (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there was a mean increase of 8.1 msec in desloratadine-treated subjects relative to placebo. Using QTc (Fridericia) there was a mean increase of 0.4 msec in desloratadine-treated subjects relative to placebo. No clinically relevant adverse events were reported.
Absorption: Following oral administration of a desloratadine 5 mg tablet once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (Tmax) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (Cmax) and AUC of 4 ng/mL and 56.9 ng∙hr/mL were observed, respectively. Neither food nor grapefruit juice had an effect on the bioavailability (Cmax and AUC) of desloratadine.
The pharmacokinetic profile of desloratadine oral solution was evaluated in a three-way crossover study in 30 adult volunteers. A single dose of 10 mL of desloratadine oral solution containing 5 mg of desloratadine was bioequivalent to a single dose of 5 mg desloratadine tablet. Food had no effect on the bioavailability (AUC and Cmax) of desloratadine oral solution.
Distribution: Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87% and 85% to 89% bound to plasma proteins, respectively. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function.
Metabolism: Desloratadine (a major metabolite of loratadine) is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated. The enzyme(s) responsible for the formation of 3-hydroxydesloratadine have not been identified. Data from clinical trials indicate that a subset of the general population has a decreased ability to form 3-hydroxydesloratadine, and are poor metabolizers of desloratadine. In pharmacokinetic studies (n=3748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours). These pharmacokinetic studies included subjects between the ages of 2 and 70 years, including 977 subjects aged 2 to 5 years, 1575 subjects aged 6 to 11 years, and 1196 subjects aged 12 to 70 years. There was no difference in the prevalence of poor metabolizers across age groups. The frequency of poor metabolizers was higher in Blacks (17%, n=988) as compared to Caucasians (2%, n=1,462) and Hispanics (2%, n=1,063). The median exposure (AUC) to desloratadine in the poor metabolizers was approximately 6-fold greater than in the subjects who are not poor metabolizers. Subjects who are poor metabolizers of desloratadine cannot be prospectively identified and will be exposed to higher levels of desloratadine following dosing with the recommended dose of desloratadine. In multidose clinical safety studies, where metabolizer status was identified, a total of 94 poor metabolizers and 123 normal metabolizers were enrolled and treated with desloratadine oral solution for 15 to 35 days. In these studies, no overall differences in safety were observed between poor metabolizers and normal metabolizers. Although not seen in these studies, an increased risk of exposure-related adverse events in patients who are poor metabolizers cannot be ruled out.
Elimination: The mean plasma elimination half-life of desloratadine was approximately 27 hours. Cmax and AUC values increased in a dose proportional manner following single oral doses between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14C-desloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxydesloratadine showed similar Tmax and half-life values compared to desloratadine.
Special Populations
Geriatric Subjects: In older subjects (≥65 years old; n=17) following multiple-dose administration of desloratadine tablets, the mean Cmax and AUC values for desloratadine were 20% greater than in younger subjects ( <65 years old). The oral total body clearance (CL/F) when normalized for body weight was similar between the two age groups. The mean plasma elimination half-life of desloratadine was 33.7 hr in subjects ≥ 65 years old. The pharmacokinetics for 3-hydroxydesloratadine appeared unchanged in older versus younger subjects. These age-related differences are unlikely to be clinically relevant and no dosage adjustment is recommended in elderly subjects.
Pediatric Subjects: In subjects 6 to 11 years old, a single dose of 5 mL of desloratadine oral solution containing 2.5 mg of desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg desloratadine tablet. In subjects 2 to 5 years old, a single dose of 2.5 mL of desloratadine oral solution containing 1.25 mg of desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults administered a single 5-mg desloratadine tablet. However, the Cmax and AUC of the metabolite (3-hydroxydesloratadine) were 1.27 and 1.61 times higher for the 5 mg dose of oral solution administered in adults compared to the Cmax and AUC obtained in children 2 to 11 years of age receiving 1.25 to 2.5 mg of desloratadine oral solution.
A single dose of either 2.5 mL or 1.25 mL of desloratadine oral solution containing 1.25 mg or 0.625 mg, respectively, of desloratadine was administered to subjects 6 to 11 months of age and 12 to 23 months of age. The results of a population pharmacokinetic analysis indicated that a dose of 1 mg for subjects aged 6 to 11 months and 1.25 mg for subjects 12 to 23 months of age is required to obtain desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg dose of desloratadine oral solution.
Renally Impaired: Desloratadine pharmacokinetics following a single dose of 7.5 mg were characterized in patients with mild (n=7; creatinine clearance 51 to 69 mL/min/1.73 m2), moderate (n=6; creatinine clearance 34 to 43 mL/min/1.73 m2), and severe (n=6; creatinine clearance 5 to 29 mL/min/1.73 m2) renal impairment or hemodialysis dependent (n=6) patients. In patients with mild and moderate renal impairment, median Cmax and AUC values increased by approximately 1.2- and 1.9-fold, respectively, relative to subjects with normal renal function. In patients with severe renal impairment or who were hemodialysis dependent, Cmax and AUC values increased by approximately 1.7- and 2.5-fold, respectively. Minimal changes in 3-hydroxydesloratadine concentrations were observed. Desloratadine and 3-hydroxydesloratadine were poorly removed by hemodialysis. Plasma protein binding of desloratadine and 3-hydroxydesloratadine was unaltered by renal impairment. Dosage adjustment for patients with renal impairment is recommended [see Dosage and Administration (2.5)].
Hepatically Impaired: Desloratadine pharmacokinetics were characterized following a single oral dose in patients with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment as defined by the Child-Pugh classification of hepatic function and 8 subjects with normal hepatic function. Patients with hepatic impairment, regardless of severity, had approximately a 2.4-fold increase in AUC as compared with normal subjects. The apparent oral clearance of desloratadine in patients with mild, moderate, and severe hepatic impairment was 37%, 36%, and 28% of that in normal subjects, respectively. An increase in the mean elimination half-life of desloratadine in patients with hepatic impairment was observed. For 3-hydroxydesloratadine, the mean Cmax and AUC values for patients with hepatic impairment were not statistically significantly different from subjects with normal hepatic function. Dosage adjustment for patients with hepatic impairment is recommended [see Dosage and Administration (2.5)].
Gender: Female subjects treated for 14 days with desloratadine tablets had 10% and 3% higher desloratadine Cmax and AUC values, respectively, compared with male subjects. The 3-hydroxydesloratadine Cmax and AUC values were also increased by 45% and 48%, respectively, in females compared with males. However, these apparent differences are not likely to be clinically relevant and therefore no dosage adjustment is recommended.
Race: Following 14 days of treatment with desloratadine tablets, the Cmax and AUC values for desloratadine were 18% and 32% higher, respectively, in Blacks compared with Caucasians. For 3-hydroxydesloratadine there was a corresponding 10% reduction in Cmax and AUC values in Blacks compared to Caucasians. These differences are not likely to be clinically relevant and therefore no dose adjustment is recommended.
Drug Interactions: In two controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) and female (n=12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days. In three separate controlled, parallel group clinical pharmacology studies, desloratadine at the clinical dose of 5 mg has been coadministered with azithromycin 500 mg followed by 250 mg once daily for 4 days (n=18) or with fluoxetine 20 mg once daily for 7 days after a 23-day pretreatment period with fluoxetine (n=18) or with cimetidine 600 mg every 12 hours for 14 days (n=18) under steady-state conditions to normal healthy male and female volunteers. Although increased plasma concentrations (Cmax and AUC 0-24 hrs) of desloratadine and 3-hydroxydesloratadine were observed (see Table 2), there were no clinically relevant changes in the safety profile of desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval), clinical laboratory tests, vital signs, and adverse events.
| Desloratadine | 3-Hydroxydesloratadine | |||
|---|---|---|---|---|
| Cmax | AUC 0-24 hrs | Cmax | AUC 0-24 hrs | |
| Erythromycin (500 mg Q8h) | + 24% | + 14% | + 43% | + 40% |
| Ketoconazole (200 mg Q12h) | + 45% | + 39% | + 43% | + 72% |
| Azithromycin (500 mg day 1, 250 mg QD × 4 days) | + 15% | + 5% | + 15% | + 4% |
| Fluoxetine (20 mg QD) | + 15% | + 0% | + 17% | + 13% |
| Cimetidine (600 mg Q12h) | + 12% | + 19% | - 11% | - 3% |
Carcinogenicity Studies
The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated desloratadine and desloratadine metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of desloratadine is not known.
In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated desloratadine and desloratadine metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.
Genotoxicity Studies
In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).
Impairment of Fertility
There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine and desloratadine metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
Reproductive Toxicology Studies
Desloratadine was not teratogenic in rats at doses up to 48 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). Reduced body weight and slow righting reflex were reported in pups at doses of 9 mg/kg/day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on pup development at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose).
The clinical efficacy and safety of desloratadine tablets were evaluated in over 2300 patients 12 to 75 years of age with seasonal allergic rhinitis. A total of 1838 patients received 2.5 to 20 mg/day of desloratadine in 4 double-blind, randomized, placebo-controlled clinical trials of 2 to 4 weeks' duration conducted in the United States. The results of these studies demonstrated the efficacy and safety of desloratadine 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. In a dose-ranging trial, desloratadine 2.5 to 20 mg/day was studied. Doses of 5, 7.5, 10, and 20 mg/day were superior to placebo; and no additional benefit was seen at doses above 5 mg. In the same study, an increase in the incidence of somnolence was observed at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3%).
In two 4-week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and concomitant asthma, desloratadine tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering desloratadine tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma.
Desloratadine tablets 5 mg once daily significantly reduced the Total Symptom Score (the sum of individual scores of nasal and non-nasal symptoms) in patients with seasonal allergic rhinitis. See Table 3.
| Treatment Group (n) | Mean Baseline*
(SEM) | Change from Baseline†
(SEM) | Placebo Comparison (P-value) |
|---|---|---|---|
| SEM=Standard Error of the Mean | |||
| Desloratadine 5 mg (171) | 14.2 (0.3) | -4.3 (0.3) | P<0.01 |
| Placebo (173) | 13.7 (0.3) | -2.5 (0.3) | |
* At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) was required for trial eligibility. TSS ranges from 0=no symptoms to 24=maximal symptoms.
† Mean reduction in TSS averaged over the 2-week treatment period.
There were no significant differences in the effectiveness of desloratadine tablets 5 mg across subgroups of patients defined by gender, age, or race.
The clinical efficacy and safety of desloratadine tablets 5 mg were evaluated in over 1300 patients 12 to 80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/day of desloratadine in two double-blind, randomized, placebo-controlled clinical trials of 4 weeks' duration conducted in the United States and internationally. In one of these studies desloratadine tablets 5 mg once daily was shown to significantly reduce the Total Symptom Score in patients with perennial allergic rhinitis (Table 4).
| Treatment Group (n) | Mean Baseline*
(SEM) | Change from Baseline†
(SEM) | Placebo Comparison (P-value) |
|---|---|---|---|
| SEM=Standard Error of the Mean | |||
| Desloratadine 5 mg (337) | 12.37 (0.18) | -4.06 (0.21) | P=0.01 |
| Placebo (337) | 12.30 (0.18) | -3.27 (0.21) | |
* At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms, each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) of at least 10 was required for trial eligibility. TSS ranges from 0=no symptoms to 24=maximal symptoms.
† Mean reduction in TSS averaged over the 4-week treatment period.
The efficacy and safety of desloratadine tablets 5 mg once daily was studied in 416 chronic idiopathic urticaria patients 12 to 84 years of age, of whom 211 received desloratadine. In two double-blind, placebo-controlled, randomized clinical trials of six weeks duration, at the pre-specified one-week primary time point evaluation, desloratadine tablets significantly reduced the severity of pruritus when compared to placebo (Table 5). Secondary endpoints were also evaluated, and during the first week of therapy desloratadine tablets 5 mg reduced the secondary endpoints, "Number of Hives" and the "Size of the Largest Hive," when compared to placebo.
| Treatment Group (n) | Mean Baseline (SEM) | Change from Baseline*
(SEM) | Placebo Comparison (P-value) |
|---|---|---|---|
| Pruritus scored 0 to 3 where 0=no symptom to 3=maximal symptom SEM=Standard Error of the Mean | |||
| Desloratadine 5 mg (115) | 2.19 (0.04) | -1.05 (0.07) | P<0.01 |
| Placebo (110) | 2.21 (0.04) | -0.52 (0.07) | |
* Mean reduction in pruritus averaged over the first week of treatment.
The clinical safety of desloratadine oral solution was documented in three, 15-day, double-blind, placebo-controlled safety studies in pediatric subjects with a documented history of allergic rhinitis, chronic idiopathic urticaria, or subjects who were candidates for antihistamine therapy. In the first study, 2.5 mg of desloratadine oral solution was administered to 60 pediatric subjects 6 to 11 years of age. The second study evaluated 1.25 mg of desloratadine oral solution administered to 55 pediatric subjects 2 to 5 years of age. In the third study, 1.25 mg of desloratadine oral solution was administered to 65 pediatric subjects 12 to 23 months of age and 1.0 mg of desloratadine oral solution was administered to 66 pediatric subjects 6 to 11 months of age. The results of these studies demonstrated the safety of desloratadine oral solution in pediatric subjects 6 months to 11 years of age.
Desloratadine oral solution is a clear, pink to light pink colored solution with characteristic bubble gum odor containing 0.5 mg/mL desloratadine and is available in the following sizes: 4 fl oz (118 mL) NDC 51672-4159-8, 6 fl oz (177 mL) NDC 51672-4159-5, 8 fl oz (237 mL) NDC 51672-4159-1.
Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Issued: September 2014
00000-0914-0
Desloratadine Oral Solution
This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Read the Patient Information that comes with desloratadine before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.
What is Desloratadine?
Desloratadine is a prescription medicine that contains the medicine desloratadine (an antihistamine).
Desloratadine is used to help control the symptoms of:
Desloratadine is not for children younger than 6 months of age.
Who should not take Desloratadine?
Do not take desloratadine if you:
Talk to your doctor before taking this medicine if you have any questions about whether or not to take this medicine.
What should I tell my doctor before taking Desloratadine?
Before you take desloratadine, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Desloratadine may affect the way other medicines work, and other medicines may affect how desloratadine works. Especially tell your doctor if you take:
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take Desloratadine?
What are the possible side effects of Desloratadine?
Desloratadine may cause serious side effects, including:
The most common side effects of desloratadine in adults and children 12 years of age and older with allergic rhinitis include:
| • sore throat | • dry mouth | • muscle pain |
| • tiredness | • sleepiness | • menstrual pain |
Increased sleepiness or tiredness can happen if you take more desloratadine than your doctor prescribed to you.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of desloratadine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Desloratadine?
General information about Desloratadine
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use desloratadine for a condition for which it was not prescribed. Do not give desloratadine to other people, even if they have the same condition you have. It may harm them.
This Patient Information leaflet summarizes the most important information about desloratadine. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about desloratadine that is written for health professionals.
What are the ingredients in Desloratadine Oral Solution?
Active ingredient: desloratadine
Inactive ingredients: bubble gum flavor, citric acid anhydrous, D&C Red No. 33, noncrystallizing sorbitol solution (70%), propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, and sucrose.
Trademarks are the property of their respective owners.
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Issued: September 2014
00000-0914-0
4 fl oz (118 mL)
NDC 51672-4159-8
Desloratadine
Oral Solution
0.5 mg/mL
PHARMACIST: Dispense
the accompanying Patient
Information leaflet to
each patient.
Contains sodium
metabisulfite, a sulfite
that may cause
allergic-type reactions.
Keep this and all medications
out of the reach of children.
Rx only
TARO
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Desloratadine | ACTIVE INGREDIENT | FVF865388R | 2 | |
| Desloratadine | ACTIVE MOIETY | FVF865388R | 2 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| D&C Red No. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 2 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | 2 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| trisodium citrate dihydrate | INACTIVE INGREDIENT | B22547B95K | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51672-4159 | 51672-4159-8, 51672-4159-5, 51672-4159-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Desloratadine | FVF865388R | ACTIB |
| anhydrous citric acid | XF417D3PSL | IACT |
| D&C Red No. 33 | 9DBA0SBB0L | IACT |
| sorbitol | 506T60A25R | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| trisodium citrate dihydrate | B22547B95K | IACT |
| sodium metabisulfite | 4VON5FNS3C | IACT |
| sucrose | C151H8M554 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / SUBCUTANEOUS | 75 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / INTRAVENOUS | 3480 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | CREAM / TOPICAL | 2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INFILTRATION | 0.5 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION / INTRAMUSCULAR | 3480 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 22 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INTRAPERITONEAL | 0.33 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | TABLET / ORAL | 8 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.15 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| sorbitol | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | TABLET / SUBLINGUAL | 2 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / ORAL | 1200 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRACARDIAC | 25 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.15 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / INTRAMUSCULAR | 96 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | CREAM / TOPICAL | 0.2 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | FILM / SUBLINGUAL | 7 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| D&C Red No. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, LIQUID FILLED / ORAL | 0.01 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | SYSTEM / IONTOPHORESIS | 0.5 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202592-001 | DESLORATADINE | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | AA | 2015-06-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202592-001 | DESLORATADINE | 0.5MG/ML | SOLUTION / ORAL | 2015-06-30 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A202592-001 | AA | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | A202592-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202592-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202592-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202592-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202592-001 | AA | 1 | ea99ee380514… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e3d4c62-ca09-4a45-8fe8-0faccb492037 | 6de2ba2e-dcfd-4efa-b24f-d6cbbe15e643 | 2014-10-02 | Warnings, Adverse reactions | 4e3d4c62-ca09-4a45-8fe8-0faccb492037 6de2ba2e-dcfd-4efa-b24f-d6cbbe15e643 |
Adverse event summaries are temporarily unavailable. Other product information remains available.