VASCEPA SIDE EFFECTS
- Generic Name: icosapent ethyl capsules
- Brand Name: Vascepa
- Drug Class: Lipid-Lowering Agents, Other
SIDE EFFECTS
The following important adverse reactions are described below and elsewhere in the labeling:
- Atrial Fibrillation or Atrial Flutter
- Potential for Allergic Reactions in Patients with Fish Allergy
- Bleeding
Clinical Trials Experience
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.
Cardiovascular Outcomes Trial
In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 8,179 statin-stabilized patients were randomized to receive VASCEPA or placebo and followed for a median of 4.9 years. The median age at baseline was 64 years, 29% were women, 90% White, 5% Asian, 2% were Black, and 4% identified as Hispanic ethnicity.
Common adverse reactions (incidence ≥3% on VASCEPA and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation.
Hypertriglyceridemia Trials
In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with VASCEPA at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.
Postmarketing Experience
Additional adverse reactions have been identified during post-approval use of VASCEPA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Diarrhea
- Blood triglycerides increased
- Abdominal discomfort
- Pain in the extremities
SRC: NLM .