Drug Safety Information for INTELENCE (Etravirine)

FDA Safety-related Labeling Changes for INTELENCE (ETRAVIRINE) Rx Drug: Safety Information Link

Adverse Drug Reactions for INTELENCE* (Etravirine)

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 INTELENCE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug interaction	111
2	Rash	102
3	Lipodystrophy acquired	82
4	Pyrexia	76
5	Anaemia	71
6	Diarrhoea	64
7	Drug ineffective	61
8	Nausea	60
9	Renal failure acute	59
10	Neuropathy peripheral	52
11	Fatigue	52
12	Thrombocytopenia	51
13	Abortion spontaneous	48
14	Asthenia	48
15	Abdominal pain	48
16	Death	47
17	Vomiting	47
18	Headache	46
19	Pancytopenia	45
20	Myocardial infarction	43

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

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

	Reason	# of FDA Reports
1	Hiv infection	4428
2	Product used for unknown indication	731
3	Antiretroviral therapy	233
4	Maternal exposure timing unspecified	116
5	Maternal exposure during pregnancy	105
6	Antiviral treatment	92
7	Hiv test positive	81
8	Acquired immunodeficiency syndrome	28
9	Pathogen resistance	13
10	Foetal exposure during pregnancy	10

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

Types of Adverse Events for INTELENCE

Total Reports Filed with FDA: 7608

Number of FDA Adverse Event Reports by Patient Age for INTELENCE

Total Reports Filed with FDA: 7608*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Etravirine (Tmc-125, Tmc 125, Intelence)

Charts are based on 7608 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.