Drug Safety Information for VIDEX (Didanosine)

Safety-related Labeling Changes for VIDEX (DIDANOSINE) Rx Drug: FDA Link

Safety-related Labeling Changes for VIDEX EC (DIDANOSINE) Rx Drug: FDA Link

Adverse Drug Reactions for VIDEX* (Didanosine)

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 VIDEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia230
2Nausea217
3Lactic acidosis211
4Vomiting205
5Anaemia195
6Drug interaction195
7Weight decreased195
8Portal hypertension193
9Diarrhoea191
10Lipodystrophy acquired186
11Pancreatitis164
12Abdominal pain158
13Aspartate aminotransferase increased147
14Ascites145
15Alanine aminotransferase increased142
16Pregnancy141
17Renal failure acute139
18Asthenia136
19Renal failure126
20Fatigue117

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

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

Reason # of FDA Reports
1Hiv infection12265
2Product used for unknown indication1077
3Antiretroviral therapy453
4Acquired immunodeficiency syndrome387
5Hiv test positive215
6Maternal exposure during pregnancy206
7Antiviral treatment98
8Antiviral prophylaxis84
9Human immunodeficiency virus transmission78
10Prophylaxis against hiv infection62

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


Types of Adverse Events for VIDEX

Total Reports Filed with FDA: 21283


Number of FDA Adverse Event Reports by Patient Age for VIDEX

Total Reports Filed with FDA: 21283*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Didanosine (Videx ec, Didanosine, Videx)

Charts are based on 21283 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 VIDEX 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.