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.
|ZOLOFT (N=3066)||Placebo (N=2293)|
|General disorders and administration site conditions|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|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|
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.
|Male sexual dysfunction||2%||0%|
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
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