Emtricitabine and tenofovir disoproxil fumarate: adverse event reports filed with FDA

3,518

reports as suspect product

0% of all reports · about 173 a year

5

reports, 12 months to June 2026

11 in the 12 months before

98%

marked serious by the reporter

84.3% across the class

8.5%

record death among outcomes, as reported

298 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 Emtricitabine and tenofovir disoproxil fumarate reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Maternal exposure during pregnancythe mother took the medicine during pregnancy10.5%371
2. Abortion spontaneousmiscarriage10.3%361
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine9.9%349
4. Osteoporosisthinning of the bones7%248
5. Virologic failure3.7%131
6. Foetal death3%106
7. Drug ineffectivethe medicine did not work as expected3%105
8. Deaththe patient died; cause not stated by this term2.9%102
9. Treatment noncompliancethe treatment was not taken as directed1.6%58
10. Pregnancypregnancy1.6%57
11. Exposure during pregnancythe medicine was taken during pregnancy1.6%56
12. Congenital anomalya condition present at birth1.5%54
13. Premature babya baby born early1.5%53
14. Chronic kidney diseaselong-term kidney disease1.5%52
15. Stillbirth1.4%51
16. Diabetes mellitusdiabetes1.4%50
17. Off label useused for a purpose or in a way not on the label1.4%48
18. Renal impairmentreduced kidney function1.3%46
19. Anaemialow red blood cells1.2%42
20. Drug resistance1.2%42
21. Drug interactionan interaction between medicines1.1%40
22. Premature delivery1.1%39
23. Hypertensionhigh blood pressure1.1%37
24. Neoplasm malignanta cancer, type not specified1.1%37
25. Low birth weight baby1%36
26. Fatiguetiredness1%35
27. Nauseafeeling sick1%35
28. Acute HIV infection1%34
29. Depressionlow mood1%34
30. Diarrhoealoose or frequent stools1%34

Top 30 of 548 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. 38.7% 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 3,518 reports.

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 Emtricitabine and tenofovir disoproxil fumarate as a suspect or interacting product; reports listing it only as a concomitant medication (257) 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.