Omacor Adverse Reactions

Hypertriglyceridaemia: In all subjects (655) treated with Omacor for hypertriglyceridaemia, the following results were seen: Adverse events (AEs) occurred in approximately 30% of subjects.
Only 11 specific AEs occurred at a rate greater than 1%.
The most common treatment-emergent AEs were eructation (4.4%) and taste perversion (4.1%).
Treatment emergent serious adverse events occurred in 2.4% of subjects.
Four subjects (0.6%) died.
The 8 pivotal trials showed similar safety profiles.
The only potentially drug-related laboratory abnormality was mild elevation in alanine aminotransferase (ALT) levels, without concurrent elevation in aspartate aminotransferase (AST) levels.
A slight, but significant, prolongation of bleeding time has been observed without any reports of bleeding problems during clinical trials with Omacor alone. The following table summarizes the treatment-emergent adverse events experienced by subjects from placebo-controlled studies in hypertriglyceridaemia, using Omacor 4 g per day (see Pharmacology: Pharmacodynamics: CLINICAL TRIALS under Actions). (See Table 4.)

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Adverse events according to System Organ Class: The following list presents the frequencies of study related adverse events, observed both in post myocardial infarction and in hypertriglyceridaemia.
Immune system disorders: Rare: hypersensitivity.
Metabolism and nutrition disorders: Uncommon: hyperglycaemia, gout.
Nervous System disorders: Uncommon: dizziness, dysgeusia, headache.
Vascular disorders: Uncommon: hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: epistaxis.
Gastrointestinal disorders: Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting).
Uncommon: gastrointestinal hemorrhage.
Hepatobiliary disorders: Rare: liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased).
Skin and subcutaneous tissue disorders: Uncommon: rash.
Rare: urticaria.
Not known: pruritus.