Rewisca Adverse Reactions

Summary of the safety profile: The pregabalin clinical programme involved over 12,000 patients who were exposed to pregabalin, of whom over 7000 were in double-blind placebo controlled trials. The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 14% for patients receiving pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Tabulated list of adverse reactions: Selected adverse drug reactions that were treatment related in the pooled analysis of clinical trials, are listed in the table as follows by System Organ Class (SOC). The frequency of these terms has been based on all-causality adverse drug reactions in the clinical trial data set very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products. (See Table 2.)

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The following adverse drug reactions were reported during Post-Marketing Surveillance: Immune system disorders: Uncommon: Hypersensitivity; Rare: Angioedema, allergic reaction.
Nervous system disorders: Very Common: Headache; Uncommon: Loss of consciousness, mental impairment.
Eye disorders: Rare: Keratitis*.
Cardiac disorders: Rare: Congestive heart failure.
Respiratory, thoracic and mediastinal disorders: Rare: Pulmonary oedema*.
Gastrointestinal disorders: Common: Nausea, diarrhea; Rare: Swollen tongue.
Skin and subcutaneous tissue disorders: Uncommon: Face swelling, pruritus.
Renal and urinary disorders: Rare: Urinary retention.
Reproductive system and breast disorders: Rare: Gynaecomastia*.
General disorders and administration site conditions: Uncommon: Malaise.
* Adverse drug reaction frequency estimated using "The Rule of 3".