Sisalon 50

Sisalon 50 Adverse Reactions





Full Prescribing Info
Adverse Reactions
Adverse effects that occurred significantly more frequently with Sertraline than with placebo in multiple-dose studies for depression were: Gastrointestinal Disorders: Diarrhea/loose stools, dry mouth, dyspepsia and nausea.
Metabolism and Nutrition Disorders: Anorexia.
Nervous System Disorders: Dizziness, somnolence and tremor.
Psychiatric Disorders: Insomnia.
Reproductive System and Breast Disorders: Sexual dysfunction (principally ejaculatory delay in males).
Skin and Subcutaneous Tissue Disorders: Increased sweating.
The side effect profile commonly observed in double-blind, placebo-controlled studies in patients with OCD, panic disorder, PTSD, and social phobia was similar with patients with depression.
Post-marketing Data: Blood and Lymphatic System Disorders: Leucopenia and thrombocytopenia.
Cardiac Disorders: Palpitations and tachycardia.
Ear and Labyrinth Disorders: Tinnitus.
Endocrine Disorders: Hyperprolactinemia, hypothyroidism and syndrome of inappropriate ADH secretion (SIADH).
Eye Disorders: Mydriasis and abnormal vision.
Gastrointestinal Disorders: Abdominal pain, constipation, pancreatitis and vomiting.
General Disorders and Administration Site Conditions: Asthenia, chest pain, peripheral edema, fatigue, fever and malaise.
Hepatobiliary Disorders: Serious liver events (including hepatitis, jaundice and liver failure) and asymptomatic elevations in serum transminases (SGOT and SGPT).
Immune System Disorders: Allergic reaction, allergy and anaphylactoid reaction.
Investigations: Abnormal clinical laboratory results, altered platelet function, increased serum cholesterol, weight decrease and increase.
Metabolism and Nutrition Disorders: Appetite increased and hyponatremia.
Musculoskeletal and Connective Tissue Disorders: Arthralgia and muscle cramps.
Nervous System Disorders: Coma, convulsions, headache, hypoesthesia, migraine, movement disorders (including ectrapyramidal symptoms e.g. hyperkinesia, hypertonia, teeth grinding or gait abnormalities), involuntary muscle contraction, paresthesia and syncope. Also reported were signs and symptoms associated with serotonin syndrome: In cases associated with concomitant use of serotonergic drugs that included agitation, confusion, diaphoresis, diarrhea, fever, hypertension, rigidity and tachycardia.
Psychiatric Disorders: Aggressive reaction, agitation, anxiety, depressive symptoms, euphoria, hallucination, decreased female and male libido, paroniria and psychosis.
Renal and Urinary Disorders: Urinary incontinence and retention.
Reproductive System and Breast Disorders: Galactorrhea, gynecomastia, menstrual irregularities and priapism.
Respiratory, Thoracic and Mediastinal Disorders: Brochopasm and yawning.
Skin and Subcutaneous Tissue Disorders: Alopecia, angioedema, face edema, periorbital edema, photosensitivity skin reaction, pruritus, rash (including rare reports of serious exfoliative skin disorders e.g. Stevens-Johnson syndrome and epidermal necrolysis) and urticaria.
Vascular Disorders: Abnormal bleeding (e.g. epitaxis, gastrointestinal bleeding or hematuria), hot flushes and hypertension.
Others: Symptoms following discontinuation of sertraline have been reported e.g. agitation, anxiety, dizziness, headache, nausea and paresthesia.
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