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adverse reactions
ADVERSE REACTIONS During its premarketing assessment, multiple doses of sertraline were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder. Untoward events associated with this exposure were recorded by clinical investigators using 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 untoward events into a smaller number of standardized event categories. In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline. 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 Trials TABLE 2 enumerates the most common treatment-emergent adverse events associated with the use of sertraline (incidence of at least 5% for sertraline and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other * in placebo-controlled clinical trials. Most patients in major depressive disorder/other * studies received doses of 50 to 200 mg/day. TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event (1) Major Depressive Disorder/Other * Body System/Adverse Event Sertraline Hydrochloride (N = 861) Placebo (N = 853) Autonomic Nervous System Disorders Ejaculation Failure (1) 7 < 1 Mouth Dry 16 9 Sweating Increased 8 3 Central & Peripheral Nervous System Disorders Somnolence 13 6 Tremor 11 3 Dizziness 12 7 General Fatigue 11 8 Pain 1 2 Malaise < 1 1 Gastrointestinal Disorders Abdominal Pain 2 2 Anorexia 3 2 Constipation 8 6 Diarrhea/Loose Stools 18 9 Dyspepsia 6 3 Nausea 26 12 Psychiatric Disorders Agitation 6 4 Insomnia 16 9 Libido Decreased 1 < 1 Associated with Discontinuation in Placebo-Controlled Clinical Trials TABLE 3 lists the adverse events associated with discontinuation of sertraline hydrochloride treatment (incidence at least twice that for placebo and at least 1% for sertraline in clinical trials) in major depressive disorder/other. TABLE 3 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS Adverse Event Major Depressive Disorder/Other * (N = 861) Abdominal pain - Agitation 1% Anxiety - Diarrhea/loose stools 2% Dizziness - Dry mouth 1% Dyspepsia - Ejaculation failure (1) 1% Fatigue - Headache 2% Hot flushes - Insomnia 1% Nausea 4% Nervousness - Palpitation - Somnolence 1% Tremor 2% Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (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. TABLE 4 below displays the incidence of sexual side effects reported by at least 2% of patients taking sertraline in placebo-controlled trials. TABLE 4 Adverse Event Sertraline Placebo Ejaculation failure (primarily delayed ejaculation ) 14% 1% Decreased libido ** 6% 1% There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment. Priapism has been reported with all SSRIs. 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 Adverse Events in Pediatric Patients In over 600 pediatric patients treated with sertraline, the overall profile of adverse events was generally similar to that seen in adult studies. However, the following adverse events, from controlled trials, not appearing in TABLE 2 , were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate (N = 281 patients treated with sertraline): fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis and purpura. Other Events Observed During the Premarketing Evaluation of Sertraline Hydrochloride Following is a list of treatment-emergent adverse events reported during premarketing assessment of sertraline in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling. In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline who experienced an event of the type cited on at least one occasion while receiving sertraline. All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to sertraline treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with sertraline, they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section. Autonomic Nervous System Disorders Frequent: impotence Infrequent: flushing, increased saliva, cold clammy skin, mydriasis Rare: pallor, glaucoma, priapism, vasodilation Body as a Whole-General Disorders Rare: allergic reaction, allergy Cardiovascular Frequent: palpitations, chest pain Infrequent: hypertension, tachycardia, postural dizziness, postural hypotension, periorbital edema, peripheral edema, hypotension, peripheral ischemia, syncope, edema, dependent edema Rare: precordial chest pain, substernal chest pain, aggravated hypertension, myocardial infarction, cerebrovascular disorder Central and Peripheral Nervous System Disorders Frequent: hypertonia, hypoesthesia Infrequent: twitching, confusion, hyperkinesia, vertigo, ataxia, migraine, abnormal coordination, hyperesthesia, leg cramps, abnormal gait, nystagmus, hypokinesia Rare: dysphonia, coma, dyskinesia, hypotonia, ptosis, choreoathetosis, hyporeflexia Disorders of Skin and Appendages Infrequent: pruritus, acne, urticaria, alopecia, dry skin, erythematous rash, photosensitivity reaction, maculopapular rash Rare: follicular rash, eczema, dermatitis, contact dermatitis, bullous eruption, hypertrichosis, skin discoloration, pustular rash Endocrine Disorders Rare: exophthalmos, gynecomastia Gastrointestinal Disorders Frequent: appetite increased Infrequent: dysphagia, tooth caries aggravated, eructation, esophagitis, gastroenteritis Rare: melena, glossitis, gum hyperplasia, hiccup, stomatitis, tenesmus, colitis, diverticulitis, fecal incontinence, gastritis, rectum hemorrhage, hemorrhagic peptic ulcer, proctitis, ulcerative stomatitis, tongue edema, tongue ulceration General Frequent: back pain, asthenia, malaise, weight increase Infrequent: fever, rigors, generalized edema Rare: face edema, aphthous stomatitis Hearing and Vestibular Disorders Rare: hyperacusis, labyrinthine disorder Hematopoietic and Lymphatic Rare: anemia, anterior chamber eye hemorrhage Liver and Biliary System Disorders Rare: abnormal hepatic function Metabolic and Nutritional Disorders Infrequent: thirst Rare: hypoglycemia, hypoglycemia reaction Musculoskeletal System Disorders Frequent: myalgia Infrequent: arthralgia, dystonia, arthrosis, muscle cramps, muscle weakness Psychiatric Disorders Frequent: yawning, other male sexual dysfunction, other female sexual dysfunction Infrequent: depression, amnesia, paroniria, teeth-grinding, emotional lability, apathy, abnormal dreams, euphoria, paranoid reaction, hallucination, aggressive reaction, aggravated depression, delusions Rare: withdrawal syndrome, suicide ideation, libido increased, somnambulism, illusion Reproductive Infrequent: menstrual disorder, dysmenorrhea, intermenstrual bleeding, vaginal hemorrhage, amenorrhea, leukorrhea Rare: female breast pain, menorrhagia, balanoposthitis, breast enlargement, atrophic vaginitis, acute female mastitis Respiratory System Disorders Frequent: rhinitis Infrequent: coughing, dyspnea, upper respiratory tract infection, epistaxis, bronchospasm, sinusitis Rare: hyperventilation, bradypnea, stridor, apnea, bronchitis, hemoptysis, hypoventilation, laryngismus, laryngitis Special Senses Frequent: tinnitus Infrequent: conjunctivitis, earache, eye pain, abnormal accommodation Rare: xerophthalmia, photophobia, diplopia, abnormal lacrimation, scotoma, visual field defect Urinary System Disorders Infrequent : micturition frequency, polyuria, urinary retention, dysuria, nocturia, urinary incontinence Rare : cystitis, oliguria, pyelonephritis, hematuria, renal pain, strangury Laboratory Tests In man, asymptomatic elevations in serum transaminases (SGOT [or AST] and SGPT [or ALT]) have been reported infrequently (approximately 0.8%) in association with sertraline administration. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation. Sertraline therapy was associated with small mean increases in total cholesterol (approximately 3%) and triglycerides (approximately 5%), and a small mean decrease in serum uric acid (approximately 7%) of no apparent clinical importance. Other Events Observed During the Postmarketing Evaluation of Sertraline Reports of adverse events temporally associated with sertraline that have been received since market introduction, that are not listed above and that may have no causal relationship with the drug include the following: acute renal failure, anaphylactoid reaction, angioedema, blindness, optic neuritis, cataract, increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including torsade de pointes-type arrhythmias), hypothyroidism, agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, hyperglycemia, galactorrhea, hyperprolactinemia, neuroleptic malignant syndrome-like events, extrapyramidal symptoms, oculogyric crisis, serotonin syndrome, psychosis, pulmonary hypertension, severe skin reactions, which potentially can be fatal, such as Stevens-Johnson syndrome, vasculitis, photosensitivity and other severe cutaneous disorders, rare reports of pancreatitis, and liver events—clinical features (which in the majority of cases appeared to be reversible with discontinuation of sertraline) occurring in one or more patients include: elevated enzymes, increased bilirubin, hepatomegaly, hepatitis, jaundice, abdominal pain, vomiting, liver failure and death.