Lyrica CR Adverse Reactions

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.
Two randomized placebo-controlled clinical trials were conducted in patients with postherpetic neuralgia and fibromyalgia in which a total of 1,242 patients received LYRICA CR. Both studies were randomized withdrawal design where a 6-week single-blind, dose optimization phase was followed by a 13-week double-blind phase. The most common adverse events leading to discontinuation from the single-blind phase of the study occurring in greater than or equal to 0.3% of patients were dizziness, somnolence, peripheral edema, fatigue, blurred vision, and increased weight. Sixty-four percent of patients experienced adverse events during the single-blind phase, with the most common adverse events occurring in greater than or equal to 4% of patients being dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.
The pregabalin clinical program involved over 12,000 patients who were exposed to pregabalin, of whom over 7,000 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.
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, <1/10), uncommon (≥1/1,000, <1/100) and rare (<1/1,000)).
The adverse reactions listed may also be associated with the underlying disease and/or concomitant medications. (See Table 5.)

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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, diarrhoea. Rare: Swollen tongue.
Skin and subcutaneous tissue disorders: Uncommon: Face swelling, pruritus. Rare: Stevens-Johnson syndrome.
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".