Omacor Adverse Reactions

The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).
Immune system disorders: Rare: hypersensitivity.
Metabolism and nutrition disorders: Uncommon: hyperglycaemia, gout.
Nervous system disorders: Uncommon: dizziness, dysgeusia, headache.
Cardiac disorders: Common: atrial fibrillation.
Vascular disorders: Uncommon: hypotension.
Respiratory thoracic and mediastinal disorders: Uncommon: epistaxis.
Gastrointestinal disorders: Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting).
Uncommon: gastrointestinal haemorrhage.
Hepatobiliary disorders: Uncommon: liver disorders including transaminases increased (alanine aminotransferase increased and aspartate aminotransferase increased).
Skin and subcutaneous tissue disorders: Uncommon: rash.
Rare: Urticaria.
Not known: pruritus.
Description of selected adverse reactions: Atrial fibrillation: Considering seven randomized clinical trials the mean frequency in placebo treated groups was 2.8%, whereas the corresponding value in groups exposed to omega-3-fatty acids amounted to 3.4%.