Efavirenz: adverse event reports filed with FDA

9,155

reports as suspect product

0% of all reports · about 407 a year

120

reports, 12 months to June 2026

148 in the 12 months before

97.2%

marked serious by the reporter

79.6% across the class

14.3%

record death among outcomes, as reported

1,308 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Efavirenz reports recording the termmedian drug in human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor

1. Virologic failure10.2%934
2. Drug resistance7.8%713
3. Viral mutation identified7.1%651
4. Drug interactionan interaction between medicines6.8%625
5. Pathogen resistance6.4%587
6. Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.2%571
7. Depressionlow mood4.5%414
8. Treatment failurethe treatment did not work4.4%401
9. Maternal exposure during pregnancythe mother took the medicine during pregnancy4.4%399
10. Immune reconstitution inflammatory syndrome3.8%344
11. Anaemialow red blood cells3.4%310
12. Deaththe patient died; cause not stated by this term3.4%309
13. Pyrexiafever3.2%294
14. Abortion spontaneousmiscarriage3%276
15. Vomitingbeing sick3%271
16. Treatment noncompliancethe treatment was not taken as directed2.8%258
17. Immune reconstitution syndrome2.8%256
18. Exposure during pregnancythe medicine was taken during pregnancy2.6%237
19. Diarrhoealoose or frequent stools2.5%226
20. Lipodystrophy acquiredchanges in body fat distribution2.3%213
21. Nauseafeeling sick2.3%212
22. Loss of personal independence in daily activities2.3%208
23. Alanine aminotransferase increasedraised liver enzyme (ALT)2.1%196
24. Neurotoxicity2.1%192
25. Drug ineffectivethe medicine did not work as expected2%185
26. Rashskin rash2%181
27. Aspartate aminotransferase increasedraised liver enzyme (AST)1.8%169
28. Renal impairmentreduced kidney function1.7%155
29. Drug-induced liver injury1.6%146
30. Condition aggravatedthe condition being treated got worse1.5%136

Top 30 of 1,515 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 29,070 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 20.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,155 reports.

Drugs most often listed in the same reports

Other products listed in reports where Efavirenz is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Efavirenz as a suspect or interacting product; reports listing it only as a concomitant medication (2,138) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.