Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See CONTRAINDICATIONS (4)] QTc prolongation and ventricular arrhythmias when taken with pimozide [See CONTRAINDICATIONS (4), CLINICAL PHARMACOLOGY (12.2)] Suicidal thoughts and behaviors [See WARNINGS AND PRECAUTIONS (5.1)] Serotonin syndrome [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2), DRUG INTERACTIONS (7.1)] Increased risk of bleeding [See WARNINGS AND PRECAUTIONS (5.3)] Activation of mania/hypomania [See WARNINGS AND PRECAUTIONS (5.4)] Discontinuation syndrome [See WARNINGS AND PRECAUTIONS (5.5)] Seizures [See WARNINGS AND PRECAUTIONS (5.6)] Angle-closure glaucoma [See WARNINGS AND PRECAUTIONS (5.7)] Hyponatremia [See WARNINGS AND PRECAUTIONS (5.8)] Sexual Dysfunction [See WARNINGS AND PRECAUTIONS (5.11)] 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 sertraline hydrochloride (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 sertraline hydrochloride 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 sertraline hydrochloride-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 sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.
MDD: somnolence;
OCD: insomnia, agitation;
PD: constipation, agitation;
5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients.
The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table
No suicides occurred in any of the pediatric studies.
There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months.
Like all medications, Sertraline Hcl can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: