Drug Safety Information for SUSTIVA (Efavirenz)

Safety-related Labeling Changes for SUSTIVA (EFAVIRENZ) Rx Drug: FDA Link

Safety-related Labeling Changes for ATRIPLA (EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE) Rx Drug: FDA Link

Adverse Drug Reactions for SUSTIVA* (Efavirenz)

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 SUSTIVA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	494
2	Diarrhoea	385
3	Rash*	371
4	Anaemia	365
5	Immune reconstitution syndrome	359
6	Vomiting	354
7	Pregnancy	353
8	Nausea	342
9	Drug interaction	254
10	Dizziness*	246
11	Renal failure acute	227
12	Headache	220
13	Dyspnoea	218
14	Alanine aminotransferase increased	217
15	Depression	213
16	Asthenia	205
17	Aspartate aminotransferase increased	198
18	Abortion spontaneous	193
19	Fatigue*	192
20	Malaise	188

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

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

	Reason	# of FDA Reports
1	Hiv infection*	20001
2	Product used for unknown indication	1392
3	Antiretroviral therapy	944
4	Acquired immunodeficiency syndrome	868
5	Hiv test positive	268
6	Maternal exposure during pregnancy	202
7	Antiviral treatment	199
8	Prophylaxis against hiv infection	163
9	Maternal exposure timing unspecified	67
10	Retroviral infection	45

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

Types of Adverse Events for SUSTIVA

Total Reports Filed with FDA: 32956

Number of FDA Adverse Event Reports by Patient Age for SUSTIVA

Total Reports Filed with FDA: 32956*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Efavirenz (Sustiva, Stocrin)

Charts are based on 32956 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.

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.