Lovaza
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions reported in at least 3% and at a greater rate than placebo for patients treated with LOVAZA based on pooled data across 23 clinical studies are listed in Table 1.
Table 1. Adverse Reactions Occurring at Incidence ≥ 3%
and Greater than Placebo in Clinical Studies of LOVAZA
| BODY SYSTEM Adverse Event* |
LOVAZA 4 grams/day (N = 655) |
Placebo (N = 370) |
||
| n | % | n | % | |
| Eructation | 29 | 4 | 5 | 1 |
| Dyspepsia | 22 | 3 | 6 | 2 |
| Taste perversion | 27 | 4 | 1 | < 1 |
| * Studies included subjects with HTG and severe HTG. | ||||
Additional adverse reactions from clinical studies 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.
Read the Lovaza (omega-3-acid ethyl esters) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
Anticoagulants or Other Drugs Affecting Coagulation
Some studies with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical studies have not been done to thoroughly examine the effect of LOVAZA and concomitant anticoagulants. Patients receiving treatment with LOVAZA and an anticoagulant or other drug affecting coagulation should be monitored periodically (e.g., aspirin, NSAIDS, warfarin, coumarin).
Drug Abuse And Dependence
LOVAZA does not have any known drug abuse or withdrawal effects.
Last reviewed on RxList: 2/10/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Lovaza Information
Lovaza - User Reviews
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Report Problems to the Food and Drug Administration
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