Apo-Sertraline Adverse Reactions

Clinical Trial Data: Side effects that occurred significantly more frequently with sertraline than with placebo in multiple-dose studies for depression were: Autonomic Nervous System: Dry mouth and increased sweating.
Central and Peripheral Nervous System: Dizziness and tremor.
Gastrointestinal: Diarrhea/loose stools, dyspepsia and nausea.
Psychiatric: Anorexia, insomnia and somnolence.
Reproductive: Sexual dysfunction (principally ejaculatory delay in males).
The side effect profile commonly observed in double-blind, placebo-controlled studies in patients with OCD, panic disorder and PTSD was similar to that observed in clinical trials in patients with depression.
Post-Marketing Data: Voluntary reports of adverse events in patients receiving sertraline since market introduction have been received.
They include the following: Autonomic Nervous System: Mydriasis and priapism.
Body as a Whole: Allergic reaction, allergy, anaphylactoid reaction, asthenia, fatigue, fever, hot flushes, malaise, decreased and increased weight.
Cardiovascular: Chest pain, edema peripheral, hypertension, palpitations, periorbital edema, syncope and tachycardia.
Central and Peripheral Nervous System: Coma, convulsions, headache, migraine, movement disorders (including extrapyramidal symptoms eg, hyperkinesia, hypertonia, teeth grinding or gait abnormalities), involuntary muscle contractions, paresthesia and hypoesthesia. Also reported were signs and symptoms associated with serotonin syndrome: In some cases associated with concomitant use of serotonergic drugs, that included agitation, confusion, diaphoresis, diarrhea, fever, hypertension, rigidity and tachycardia.
Endocrinological: Galactorrhea, gynecomastia, hyperprolactinemia, hypothyroidism and syndrome of inappropriate ADH secretion (SIADH).
Gastrointestinal: Abdominal pain, increased appetite, constipation, pancreatitis, vomiting and microscopic colitis.
Hearing/Vestibular: Tinnitus.
Hematopoietic: Altered platelet function, abnormal bleeding (eg, epistaxis, gastrointestinal bleeding or hematuria), leucopenia, purpura and thrombocytopenia.
Laboratory Changes: Abnormal clinical laboratory results.
Liver/Biliary: Serious liver events (including hepatitis, jaundice and liver failure) and asymptomatic elevations in serum transaminases (SGOT and SGPT).
Metabolic/Nutritional: Hyponatremia and increased serum cholesterol.
Musculoskeletal: Arthralgia.
Psychiatric: Agitation, aggressive reaction, anxiety, depressive symptoms, euphoria, hallucination, decreased libido in male and female, paroniria, psychosis and yawning.
Reproductive: Menstrual irregularities.
Respiratory: Bronchospasm.
Skin: Alopecia, angioedema, photosensitivity skin reaction, pruritus, rash (including rare reports of serious exfoliative skin disorders eg, Stevens-Johnson syndrome and epidermal necrolysis) and urticaria.
Urinary: Face edema, urinary incontinence and urinary retention.
Vision: Abnormal vision.
Others: Symptoms following the discontinuation of sertraline have been reported and included agitation, anxiety, dizziness, headache, nausea and paresthesia.