LOVAZA SIDE EFFECTS
- Generic Name: omega-3-acid ethyl esters
- Brand Name: Lovaza
- Drug Class: Lipid-Lowering Agents, Other, Nutritionals, Other
SIDE EFFECTS
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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions reported in at least 3% of subjects treated with LOVAZA and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1.
Table 1: Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of LOVAZA
| Adverse Reactiona | LOVAZA (n = 655) |
Placebo (n = 370) |
||
| n | % | n | % | |
| Eructation | 29 | 4 | 5 | 1 |
| Dyspepsia | 22 | 3 | 6 | 2 |
| Taste perversion | 27 | 4 | 1 | <1 |
| a Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. | ||||
Additional adverse reactions from clinical trials are listed below:
Digestive System
Constipation, gastrointestinal disorder, and vomiting.
Metabolic And Nutritional Disorders
Increased ALT and increased AST.
Skin
Pruritus and rash.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of LOVAZA. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.
The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.
SRC: NLM .