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ZOLOFT®Adverse Reactions (sertraline HCl)


The following adverse reactions are described in more detail in other sections of the prescribing information:

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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below are from randomized, double-blind, placebo-controlled trials of ZOLOFT (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to ZOLOFT for 8 to12 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 ZOLOFT-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of ZOLOFT (≥5% and twice placebo) by indication that were not mentioned previously.

  • MDD: somnolence;
  • OCD: insomnia, agitation;
  • PD: constipation, agitation;
  • PTSD: fatigue;
  • PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain;
  • SAD: insomnia, dizziness, fatigue, dry mouth, malaise.
Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD*
Adverse reactions that occurred greater than 2% in ZOLOFT-treated patients and at least 2% greater in ZOLOFT-treated patients than placebo-treated patients.
Denominator used was for male patients only (n=1316 ZOLOFT; n=973 placebo).
Cardiac disorders
Eye disorders
  Visual impairment4%2%
Gastrointestinal Disorders
  Diarrhea/Loose Stools20%10%
  Dry mouth14%9%
General disorders and administration site conditions
Metabolism and nutrition disorders
  Decreased appetite7%2%
Nervous system disorders
Psychiatric Disorders
  Libido Decreased6%2%
Reproductive system and breast disorders
  Ejaculation failure 8%1%
  Erectile dysfunction 4%1%
  Ejaculation disorder 3%0%
  Male sexual dysfunction [See Warnings and Precautions (5.11)]2%0%
Skin and subcutaneous tissue disorders

Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials

In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received ZOLOFT 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 ZOLOFT-treated patients:

  • MDD, OCD, PD, PTSD, SAD and PMDD: 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.
  • PD: nervousness and 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 4 below displays the incidence of sexual adverse reactions reported by at least 2% of ZOLOFT-treated patients and twice placebo from pooled placebo-controlled trials. 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 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from ZOLOFT Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD
Men only (N=1316)(N=973)
  Ejaculation failure8%1%
  Libido decreased7%2%
  Erectile dysfunction4%1%
  Ejaculation disorder3%0%
  Male sexual dysfunction2%0%
Women only(N=1750)(N=1320)
  Libido decreased4%2%

Adverse Reactions in Pediatric Patients

In 281 pediatric patients treated with ZOLOFT 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 3 (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 ZOLOFT

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with ZOLOFT 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 Post-marketing Experience

The following adverse reactions have been identified during postapproval use of ZOLOFT. 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) [See Clinical Pharmacology (12.2)]
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
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
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