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adverse reactions
ADVERSE REACTIONS In one of three placebo-controlled, continuous-dosing trials and one placebo-controlled, intermittent-dosing trial of fluoxetine in PMDD, treatment-emergent adverse events reporting rates were assessed. The information from Table 2 included under ADVERSE REACTIONS is based on data from the continuous-dosing trial at the recommended dose of fluoxetine (fluoxetine 20 mg, N = 104; placebo, N = 108) and data from the intermittent-dosing trial of fluoxetine in PMDD (fluoxetine 20 mg, N = 86; placebo, N = 88). In addition, a broader set of information on treatment-emergent adverse events in the population of female patients, 18 to 45 years of age from the U.S. placebo-controlled depression, OCD, and bulimia clinical trials, is presented for comparison (see Table 3). Adverse events were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a limited (i.e., reduced) number of standardized event categories. In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse events. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it. The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied. Incidence in Placebo-Controlled PMDD Clinical Trials: Table 2 enumerates the most common treatment-emergent adverse events associated with the use of fluoxetine 20 mg (incidence of at least 5% for fluoxetine 20 mg and greater than placebo) for the treatment of PMDD. Table 2: Most Common Treatment-Emergent Adverse Events: Incidence in PMDD Placebo-Controlled Clinical Trials Percentage of Patients Reporting Event Body System/ Adverse Event Included in the table are events reported by at least 5% of patients taking fluoxetine 20 mg either continuously or intermittently. For additional adverse event terms referenced in PRECAUTIONS, reporting rates for fluoxetine 20 mg continuous and intermittent were, respectively: anxiety 4.8%, 1.2% and anorexia 3.8%, 3.5%. Fluoxetine 20 mg/day Continuously (N = 104) Fluoxetine 20 mg/day Intermittently (N = 86) Placebo (Pooled) (N = 196) Body as a Whole Headache 13 15 11 Asthenia 12 8 4 Pain 9 3 7 Accidental injury 8 1 5 Infection 7 0 3 Flu syndrome 12 3 7 Digestive System Nausea 13 9 6 Diarrhea 6 2 6 Nervous System Insomnia 9 10 7 Dizziness 7 2 3 Nervousness 7 3 3 Thinking abnormal Thinking abnormal is the COSTART term that captures concentration difficulties. 6 5 0 Libido decreased 3 9 1 Respiratory System Rhinitis 23 16 15 Pharyngitis 10 6 5 Incidence in U.S. Depression, OCD, and Bulimia Placebo-Controlled Clinical Trials (Excluding Data from Extensions of Trials): Table 3 enumerates the most common treatment-emergent adverse events associated with the use of fluoxetine up to 80 mg (incidence of at least 2% for fluoxetine and greater than placebo) in female patients ages 18 to 45 years from U.S. placebo-controlled clinical trials in the treatment of depression, OCD, and bulimia. Table 3: Treatment-Emergent Adverse Events: Incidence in Female Patients Ages 18 to 45 Years in U.S. Depression, OCD, and Bulimia Placebo-Controlled Clinical Trials Percentage of Patients Reporting Event Body System/ Adverse Event Included are events reported by at least 2% of patients taking fluoxetine, except the following events, which had an incidence on placebo > fluoxetine (depression, OCD, and bulimia combined): back pain, cough increased, depression (includes suicidal thoughts), dysmenorrhea, flatulence, infection, myalgia, pain, pruritus, rhinitis, sinusitis. Fluoxetine (N = 1,145) Placebo (N = 553) Body as a Whole Headache 24 21 Asthenia 14 6 Flu syndrome 7 3 Abdominal pain 6 5 Accidental injury 4 3 Fever 3 2 Cardiovascular System Palpitation 3 2 Vasodilatation 3 1 Digestive System Nausea 27 11 Anorexia 11 4 Dry mouth 11 8 Diarrhea 10 7 Dyspepsia 7 5 Constipation 5 3 Vomiting 3 2 Metabolic and Nutritional Disorders Weight loss 3 1 Nervous System Insomnia 24 11 Nervousness 14 10 Anxiety 13 9 Somnolence 13 6 Tremor 12 1 Dizziness 11 5 Libido decreased 4 1 Abnormal dreams 3 2 Thinking abnormal Thinking abnormal is the COSTART term that captures concentration difficulties. 3 2 Respiratory System Pharyngitis 6 5 Yawn 5 -- Skin and Appendages Sweating 8 3 Rash 5 3 Special Senses Abnormal vision 3 1 Urogenital System Urinary frequency 2 1 -- Incidence less than 0.5%. Associated with Discontinuation in Two Placebo-Controlled PMDD Clinical Trials: In a continuous-dosing PMDD placebo-controlled trial, the most common adverse event (incidence at least 2% for fluoxetine 20 mg and greater than placebo) associated with discontinuation was nausea (3% for fluoxetine 20 mg, N = 104 and 1% for placebo, N = 108). In an intermittent-dosing placebo-controlled trial, no events associated with discontinuation reached an incidence of 2% for fluoxetine 20 mg. In these clinical trials, more than one event may have been recorded as the cause of discontinuation. Associated with Discontinuation in U.S. Depression, OCD, and Bulimia Placebo-Controlled Clinical Trials (Excluding Data from Extensions of Trials): In female patients age 18 to 45 years in U.S. depression, OCD, and bulimia placebo-controlled clinical trials combined, which collected a single primary event associated with discontinuation (incidence at least 1% for fluoxetine and at least twice that for placebo), insomnia (1%, N = 561) was the only event reported. Female Sexual Dysfunction with SSRIs: Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a mood-related disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance, cited in product labeling, are likely to underestimate their actual incidence. For example, in women (age 18 to 45) receiving fluoxetine for indications other than PMDD, decreased libido was seen at an incidence of 4% for fluoxetine compared with 1% for placebo. There have been spontaneous reports in women (age 18 to 45) taking fluoxetine for indications other than PMDD of orgasmic dysfunction, including anorgasmia. There are no adequate and well controlled studies examining sexual dysfunction with fluoxetine treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects. Other Events Observed in U.S. Clinical Trials Following is a list of all treatment-emergent adverse events reported at anytime by females and males taking fluoxetine in all U.S. clinical trials for conditions other than PMDD as of May 8, 1995 (10,782 patients) except (1) those listed in the body or footnotes of Tables 2 or 3 above or elsewhere in labeling; (2) those for which the COSTART terms were uninformative or misleading; (3) those events for which a causal relationship to fluoxetine use was considered remote; (4) events occurring in only one patient treated with fluoxetine and which did not have a substantial probability of being acutely life threatening; and (5) events that could only occur in males. Events are classified within body system categories using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients. Body as a Whole: Frequent: chest pain and chills; Infrequent: chills and fever, face edema, intentional overdose, malaise, pelvic pain, suicide attempt; Rare: acute abdominal syndrome, hypothermia, intentional injury, neuroleptic malignant syndrome, photosensitivity reaction. Cardiovascular System: Frequent: hemorrhage, hypertension; Infrequent: angina pectoris, arrhythmia, congestive heart failure, hypotension, migraine, myocardial infarct, postural hypotension, syncope, tachycardia, vascular headache; Rare: atrial fibrillation, bradycardia, cerebral embolism, cerebral ischemia, cerebrovascular accident, extrasystoles, heart arrest, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation. Digestive System: Frequent: increased appetite, nausea and vomiting; Infrequent: aphthous stomatitis, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, liver function tests abnormal, melena, mouth ulceration, nausea/vomiting/diarrhea, stomach ulcer, stomatitis, thirst; Rare: biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal ulcer, fecal incontinence, gastrointestinal hemorrhage, hematemesis, hemorrhage of colon, hepatitis, intestinal obstruction, liver fatty deposit, pancreatitis, peptic ulcer, rectal hemorrhage, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema. Endocrine System: Infrequent: hypothyroidism; Rare: diabetic acidosis, diabetes mellitus. Hemic and Lymphatic System: Infrequent: anemia, ecchymosis; Rare: blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, petechia, purpura, thrombocythemia, thrombocytopenia. Metabolic and Nutritional: Frequent: weight gain; Infrequent: dehydration, generalized edema, gout, hypercholesteremia, hyperlipemia, hypokalemia, peripheral edema; Rare: alcohol intolerance, alkaline phosphatase increased, BUN increased, creatine phosphokinase increased, hyperkalemia, hyperuricemia, hypocalcemia, iron deficiency anemia, SGPT increased. Musculoskeletal System: Infrequent: arthritis, bone pain, bursitis, leg cramps, tenosynovitis; Rare: arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, rheumatoid arthritis. Nervous System: Frequent: agitation, amnesia, confusion, emotional lability, paresthesia, and sleep disorder; Infrequent: abnormal gait, acute brain syndrome, akathisia, apathy, ataxia, buccoglossal syndrome, CNS depression, CNS stimulation, depersonalization, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, hypesthesia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, neurosis, paranoid reaction, personality disorder 1 , psychosis, vertigo; Rare: abnormal electroencephalogram, antisocial reaction, circumoral paresthesia, coma, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, reflexes decreased, reflexes increased, stupor. Respiratory System: Infrequent: asthma, epistaxis, hiccup, hyperventilation; Rare: apnea, atelectasis, cough decreased, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, pneumothorax, stridor. Skin and Appendages: Infrequent: acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer, vesiculobullous rash; Rare: furunculosis, herpes zoster, hirsutism, petechial rash, psoriasis, purpuric rash, pustular rash, seborrhea. Special Senses: Frequent: ear pain, taste perversion, tinnitus; Infrequent: conjunctivitis, dry eyes, mydriasis, photophobia; Rare: blepharitis, deafness, diplopia, exophthalmos, eye hemorrhage, hyperacusis, iritis, parosmia, scleritis, strabismus, taste loss, visual field defect. Urogenital System: Infrequent: abortion 2 , albuminuria, amenorrhea 2 , anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation 2 , fibrocystic breast 2 , hematuria, leukorrhea 2 , menorrhagia 2 , metrorrhagia 2 , nocturia, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage 2 ; Rare: breast engorgement, glycosuria, hypomenorrhea 2 , kidney pain, oliguria, uterine hemorrhage 2 , uterine fibroids enlarged 2 . 1 Personality disorder is the COSTART term for designating non-aggressive objectionable behavior. 2 Adjusted for gender. Postintroduction Reports Voluntary reports of adverse events temporally associated with fluoxetine that have been received since market introduction of fluoxetine and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation, cataract, cerebral vascular accident, cholestatic jaundice, confusion, dyskinesia (including, for example, a case of buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported to develop in a 77 year old female after 5 weeks of fluoxetine therapy and which completely resolved over the next few months following drug discontinuation), eosinophilic pneumonia, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, misuse/abuse, movement disorders developing in patients with risk factors including drugs associated with such events and worsening of pre-existing movement disorders, optic neuritis, pancreatitis, pancytopenia, priapism, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson Syndrome, sudden unexpected death, suicidal ideation, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after drug withdrawal, ventricular tachycardia (including Torsades de pointes-type arrhythmias), and violent behaviors.