Drug Safety Information for TRIZIVIR (Abacavir sulfate; lamivudine; zidovudine)

Safety-related Labeling Changes for TRIZIVIR (ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE) Rx Drug: FDA Link

Adverse Drug Reactions for TRIZIVIR* (Abacavir sulfate; lamivudine; zidovudine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TRIZIVIR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia90
2Nausea60
3Vomiting57
4Rash56
5Anaemia55
6Diarrhoea47
7Fatigue38
8Hypersensitivity38
9Myocardial infarction36
10Drug interaction35
11Dyspnoea34
12Headache34
13Premature baby32
14Asthenia31
15Malaise29
16Abdominal pain27
17Weight decreased26
18Lipodystrophy acquired25
19Death24
20Drug resistance23

* This side effect also appears in "Top 10 Side Effects of TRIZIVIR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TRIZIVIR
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hiv infection2649
2Product used for unknown indication172
3Antiviral prophylaxis115
4Maternal exposure during pregnancy111
5Acquired immunodeficiency syndrome104
6Antiretroviral therapy98
7Asymptomatic hiv infection46
8Antiviral treatment41
9Hiv test positive30
10Ill-defined disorder22

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TRIZIVIR

Total Reports Filed with FDA: 4413


Number of FDA Adverse Event Reports by Patient Age for TRIZIVIR

Total Reports Filed with FDA: 4413*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Abacavir sulfate; lamivudine; zidovudine (Trizivir)

Charts are based on 4413 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TRIZIVIR Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.