Sertralineside effects

The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline or excipients of sertraline hydrochloride capsules Suicidal Thoughts and Behaviors in Adolescent and Young Adults Serotonin Syndrome Increased Risk of Bleeding Activation of Mania or hypomania Discontinuation Syndrome Seizures Angle-Closure Glaucoma Hyponatremia QTc Prolongation Allergic reactions to FD&C Yellow No. 5 (Tartrazine) Sexual Dysfunction Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled clinical trials with sertraline hydrochloride were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido To report SUSPECTED ADVERSE REACTIONS, contact Appco Pharma LLC at 1-855-672-7726 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience 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 the rates in the clinical trials of another drug and may not reflect rates observed in practice. The safety of sertraline hydrochloride capsules for the treatment of MDD and OCD is based on adequate and well- controlled studies of another sertraline hydrochloride product. Below is a display of adverse reactions of sertraline hydrochloride (referred to as “sertraline” in this section) from those adequate and well-controlled studies in MDD, OCD, and other conditions. The data described below reflect exposure in randomized, double-blind, placebo-controlled trials of sertraline in 3066 adults. These 3066 patients exposed to sertraline for 8 to 12 weeks represent 568 patient- years of exposure. The mean age was 40 years; 57% were females and 43% were males. The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline-treated patients (MDD, OCD, and other conditions) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 2). The following are the most common adverse reactions in trials of sertraline (≥5% and twice placebo) by indication that were not mentioned previously.

MDD: somnolence OCD: insomnia, agitation Table 2: Common Adverse Reactions (Greater than 2% of Adults with MDD, OCD, and Other Conditions Treated with sertraline hydrochloride and Greater than or Equal to Twice the Incidence of Placebo) in Pooled Placebo-Controlled Trials * Sertraline Hydrochloride (N=3066) % Placebo (N=2293) % Cardiac disorders Palpitations 4 2 Eye disorders Visual impairment 4 2 Gastrointestinal Disorders Nausea 26 12 Diarrhea/Loose Stools 20 10 Dry mouth 14 9 Dyspepsia 8 4 Constipation 6 4 Vomiting 4 1 General disorders and administration site conditions Fatigue 12 8 Metabolism and nutrition disorders Decreased appetite 7 2 Nervous system disorders Dizziness 12 8 Somnolence 11 6 Tremor 9 2 Psychiatric Disorders Insomnia 20 13 Agitation 8 5 Libido Decreased 6 2 Reproductive system and breast disorders Ejaculation failure 8 1 Erectile dysfunction 4 1 Ejaculation disorder 3 0 Male sexual dysfunction 2 0 Skin and subcutaneous tissue disorders Hyperhidrosis 7 3 Denominator used was for male patients only (n=1316 sertraline; n=973 placebo). *Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients. Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controlled studies, 368 (12%) of the 3066 patients who received sertraline discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline-treated patients: All sertraline -treated patients (MDD, OCD, and Other Conditions): nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%). MDD (>2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting.

OCD: somnolence. Male and Female Sexual Dysfunction 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 SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. Table 3 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline -treated patients and twice placebo from pooled placebo-controlled trials of MDD, OCD, and other conditions. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.

Table 3: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from sertraline hydrochloride Pooled Controlled Trials in Adults with MDD, OCD, and Other Conditions Sertraline Hydrochloride % Placebo % Men only (N=1316) (N=973) Ejaculation failure 8 1 Libido decreased 7 2 Erectile dysfunction 4 1 Ejaculation disorder 3 0 Male sexual dysfunction 2 0 Women only (N=1750) (N=1320) Libido decreased 4 2 Adverse Reactions in Pediatric Patients In 281 pediatric patients treated with sertraline in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 2 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety. Other Adverse Reactions Observed During the Premarketing Evaluation of sertraline Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with sertraline were: Cardiac disorders – tachycardia Ear and labyrinth disorders – tinnitus Endocrine disorders - hypothyroidism Eye disorders - mydriasis, blurred vision Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia Hepatobiliary disorders - elevated liver enzymes Immune system disorders - anaphylaxis Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite Musculoskeletal and connective tissue disorders – arthralgia, muscle spasms, tightness, or twitching Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination Renal and urinary disorders - hematuria Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria Vascular disorders - hemorrhage, hypertension, vasodilation

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of another sertraline product. Because these reactions 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. Bleeding or clotting disorders - increased coagulation times (altered platelet function) Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH Eye disorders - blindness, optic neuritis, cataract Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness Immune system disorders - angioedema Metabolism and nutrition disorders - hyponatremia, hyperglycemia Musculoskeletal and connective tissue disorders - rhabdomyolysis, trismus Nervous system disorders - serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis Psychiatric disorders - psychosis, enuresis, paroniria Renal and urinary disorders - acute renal failure Respiratory, thoracic and mediastinal disorders - pulmonary hypertension, anosmia, hyposmia Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis