Truvada: adverse event reports filed with FDA

38,638

reports as suspect product

0.2% of all reports · about 1,798 a year

844

reports, 12 months to June 2026

1,535 in the 12 months before

85.7%

marked serious by the reporter

84.3% across the class

3.3%

record death among outcomes, as reported

1,287 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 Truvada reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Bone density decreased42.9%16,593
2. Chronic kidney diseaselong-term kidney disease26.8%10,352
3. Osteonecrosis23.6%9,124
4. Bone loss23.5%9,098
5. Renal failurekidney failure23.2%8,955
6. Multiple fractures21.2%8,181
7. Tooth loss21.1%8,142
8. Renal injury20.7%7,991
9. Osteoporosisthinning of the bones18.8%7,259
10. Skeletal injury18.6%7,170
11. Painpain, site not specified16.8%6,473
12. Emotional distressemotional distress16.4%6,332
13. Anxietyanxiety15%5,811
14. Anhedonia14.5%5,600
15. Osteopenia10.2%3,932
16. Acute kidney injurysudden loss of kidney function5.6%2,172
17. Renal impairmentreduced kidney function5.5%2,129
18. Tooth injury5.4%2,087
19. Blood creatinine increasedraised creatinine, a kidney test5.3%2,044
20. Economic problema financial problem5%1,934
21. Fracturea broken bone3.3%1,288
22. Nephropathy2.9%1,105
23. Vitamin D deficiencylow vitamin D2.8%1,093
24. Bone density abnormal2.7%1,038
25. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.6%994
26. Depressionlow mood2.3%893
27. Foot fracture1.9%725
28. End stage renal diseasekidney failure needing dialysis or transplant1.9%721
29. Off label useused for a purpose or in a way not on the label1.9%715
30. Fatiguetiredness1.7%675

Top 30 of 1,918 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 13 drugs in the human immunodeficiency virus 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 80,988 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. 81.9% 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 38,638 reports.

Drugs most often listed in the same reports

Other products listed in reports where Truvada 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 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 Truvada as a suspect or interacting product; reports listing it only as a concomitant medication (6,404) 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.