Tenofovir disoproxil fumarate: adverse event reports filed with FDA

7,400

reports as suspect product

0% of all reports · about 330 a year

150

reports, 12 months to June 2026

236 in the 12 months before

97.4%

marked serious by the reporter

88.4% across the class

10.2%

record death among outcomes, as reported

753 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 Tenofovir disoproxil fumarate reports recording the termmedian drug in hepatitis b virus nucleoside analog reverse transcriptase inhibitor

1. Virologic failure9.7%718
2. Pathogen resistance9.5%700
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine9.4%699
4. Viral mutation identified9%663
5. Drug resistance6%445
6. Maternal exposure during pregnancythe mother took the medicine during pregnancy5.1%379
7. Drug ineffectivethe medicine did not work as expected3.9%286
8. Treatment failurethe treatment did not work3.6%269
9. Abortion spontaneousmiscarriage3.5%262
10. Exposure during pregnancythe medicine was taken during pregnancy3.2%236
11. Osteoporosisthinning of the bones3.1%232
12. Deaththe patient died; cause not stated by this term3%220
13. Drug interactionan interaction between medicines3%219
14. Immune reconstitution inflammatory syndrome2.9%212
15. Nephropathy toxic2.7%201
16. Hepatitis Bhepatitis B infection2.6%191
17. Treatment noncompliancethe treatment was not taken as directed2.6%190
18. Renal impairmentreduced kidney function2.5%187
19. Acute kidney injurysudden loss of kidney function2.1%157
20. Premature babya baby born early2.1%152
21. Fanconi syndrome acquired2%147
22. Diarrhoealoose or frequent stools1.9%138
23. Alanine aminotransferase increasedraised liver enzyme (ALT)1.9%137
24. Blood creatinine increasedraised creatinine, a kidney test1.9%137
25. Nauseafeeling sick1.8%136
26. Anaemialow red blood cells1.8%134
27. Condition aggravatedthe condition being treated got worse1.8%131
28. Pyrexiafever1.8%131
29. Off label useused for a purpose or in a way not on the label1.6%121
30. Chronic kidney diseaselong-term kidney disease1.6%120

Top 30 of 1,331 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 12 drugs in the hepatitis b 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 72,523 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. 23.1% 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 7,400 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tenofovir disoproxil fumarate 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 hepatitis b 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 Tenofovir disoproxil fumarate as a suspect or interacting product; reports listing it only as a concomitant medication (1,293) 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.