Drug Safety Information for ZERIT (Stavudine)

Safety-related Labeling Changes for ZERIT (STAVUDINE) Rx Drug: FDA Link

Adverse Drug Reactions for ZERIT* (Stavudine)

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 ZERIT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Immune reconstitution syndrome294
2Lactic acidosis270
3Vomiting262
4Pyrexia252
5Lipodystrophy acquired243
6Anaemia241
7Nausea232
8Diarrhoea211
9Aspartate aminotransferase increased153
10Neuropathy peripheral*148
11Abdominal pain145
12Alanine aminotransferase increased143
13Hypertriglyceridaemia142
14Dyspnoea137
15Drug interaction135
16Weight decreased*134
17Pregnancy133
18Blood lactic acid increased129
19Drug resistance128
20Asthenia124

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

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

Reason # of FDA Reports
1Hiv infection12931
2Antiretroviral therapy688
3Acquired immunodeficiency syndrome660
4Product used for unknown indication630
5Hiv test positive269
6Maternal exposure during pregnancy137
7Antiviral treatment113
8Antiviral prophylaxis89
9Human immunodeficiency virus transmission54
10Prophylaxis51

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


Types of Adverse Events for ZERIT

Total Reports Filed with FDA: 21625


Number of FDA Adverse Event Reports by Patient Age for ZERIT

Total Reports Filed with FDA: 21625*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Stavudine (Zerit xr, Stavudine, Zerit)

Charts are based on 21625 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 ZERIT Reviews and Review Summary .

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.

Visit   DrugInformer.com more on ZERIT's side effects.