Zoloft(Sertralina) Side Effects

1. Clinical Data:

1.1 Gastrointestinal: Diarrhea/loose stools, dry mouth, dyspepsia, and nausea.

1.2 Metabolism and Nutrition: Anorexia.

1.3 Nervous System: Dizziness, somnolence, and tremor.

1.4 Psychiatric: Insomnia.

1.5 Reproductive System and Breast: Sexual dysfunction (mainly male ejaculatory delay).

1.6 Skin and Subcutaneous Tissue: Hyperhidrosis.

1.7 Blood and Lymphatic System: Neutropenia and thrombocytopenia.

2. Post-Marketing Data:

2.1 Cardiac: Palpitations and tachycardia.

2.2 Ear and Labyrinth: Tinnitus.

2.3 Endocrine: Hyperprolactinemia, hypothyroidism, and syndrome of inappropriate ADH secretion (SIADH).

2.4 Eye: Dilated pupils and visual abnormalities.

2.5 Gastrointestinal: Abdominal pain, constipation, pancreatitis, and vomiting.

2.6 General and Administration Site: Asthenia, chest pain, peripheral edema, fatigue, fever, and discomfort.

2.7 Hepato-Biliary System: Severe liver disease (including hepatitis, jaundice, and liver failure), and asymptomatic serum transaminase elevation (SGOT and SGPT).

2.8 Immune System: Allergic reaction, anaphylaxis, and anaphylactoid reaction.

2.9 Investigations: Abnormal clinical laboratory results, platelet function changes, increased serum cholesterol, weight loss, and weight gain.

2.10 Metabolism and Nutrition: Increased appetite and hyponatremia.

2.11 Musculoskeletal and Connective Tissue: Arthralgia and muscle spasm.

2.12 Nervous System: Coma, convulsion, headache, hypoesthesia, migraine, movement disorder (including extrapyramidal side effects such as hyperkinesia, increased muscle tone, bruxism, and gait abnormality), involuntary muscle contraction, paresthesia, and syncope. Symptoms and signs related to serotonin syndrome, such as anxiety, confusion, diaphoresis, diarrhea, fever, hypertension, myoclonus, and tachycardia, may occur due to concomitant use of serotonergic drugs.

2.13 Psychiatric: Aggressive reaction, agitation, anxiety, depressive symptoms, euphoria, hallucination, female decreased libido, male decreased libido, nightmare, and psychosis.

2.14 Renal and Urinary System: Urinary incontinence and urinary retention.

2.15 Reproductive System and Breast: Galactorrhea, gynecomastia, menstrual disorder, and priapism.

2.16 Respiratory, Thoracic and Mediastinal: Bronchospasm and yawning.

2.17 Skin and Subcutaneous Tissue: Alopecia, angioedema, facial edema, periorbital edema, photosensitivity reaction, pruritus, purpura, rash (rare exfoliative dermatitis such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), and urticaria.

2.18 Vascular: Abnormal bleeding (such as epistaxis, gastrointestinal bleeding, or hematuria), hot flush, and hypertension.

2.19 Injury, Poisoning and Procedural Complications: Fracture (incidence - unknown (cannot be determined from available data)).

2.20 Others: Symptoms reported after sertraline discontinuation include anxiety, worry, dizziness, headache, nausea, and paresthesia.