What the label lists and what reports show
Tenofovir disoproxil side effects
Tenofovir disoproxil's FDA label: “Most common adverse reactions (incidence greater than or equal to 10%, Grades 2 to 4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia.” FAERS holds 32,864 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is bone density decreased (10,686 reports).
- Generic listed
- Boxed warning
Check it at the source: the tenofovir disoproxil FDA label on DailyMed (effective June 7, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of tenofovir disoproxil fumarate tablets?Tenofovir disoproxil fumarate tablets may cause serious side effects, including: See “What is the most important information I should know about tenofovir disoproxil fumarate tablets?” New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with tenofovir disoproxil fumarate tablets. Your healthcare provider may tell you to take tenofovir disoproxil fumarate tablets less often, or to stop taking tenofovir disoproxil fumarate tablets if you get new or worse kidney problems. Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-1 infected person starts taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 10%, Grades 2 to 4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia.
Table 8 Selected Adverse Reactions a (Grades 2 to 4) Reported in ≥3% in Any Treatment Group in Trial 907 (0 to 48 Weeks)
| Reaction | Tenofovir Disoproxil Fumarate N=368 (Week 0 to 24) | Placebo N=182 (Week 0 to 24) | Tenofovir Disoproxil Fumarate N=368 (Week 0 to 48) | Placebo Crossover to Tenofovir Disoproxil Fumarate N=170 (Week 24 to 48) |
|---|---|---|---|---|
| Asthenia | 7% | 6% | 11% | 1% |
| Pain | 7% | 7% | 12% | 4% |
| Headache | 5% | 5% | 8% | 2% |
| Abdominal pain | 4% | 3% | 7% | 6% |
| Back pain | 3% | 3% | 4% | 2% |
| Chest pain | 3% | 1% | 3% | 2% |
| Fever | 2% | 2% | 4% | 2% |
| Diarrhea | 11% | 10% | 16% | 11% |
| Nausea | 8% | 5% | 11% | 7% |
| Vomiting | 4% | 1% | 7% | 5% |
| Anorexia | 3% | 2% | 4% | 1% |
| Dyspepsia | 3% | 2% | 4% | 2% |
| Flatulence | 3% | 1% | 4% | 1% |
| Pneumonia | 2% | 0% | 3% | 2% |
| Depression | 4% | 3% | 8% | 4% |
| Insomnia | 3% | 2% | 4% | 4% |
| Peripheral neuropathy b | 3% | 3% | 5% | 2% |
| Dizziness | 1% | 3% | 3% | 1% |
| Rash event c | 5% | 4% | 7% | 1% |
| Sweating | 3% | 2% | 3% | 1% |
| Myalgia | 3% | 3% | 4% | 1% |
| Weight loss | 2% | 1% | 4% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.2) ]. Immune Reconstitution Syndrome [see Warnings and Precautions (5.4) ]. Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ]. Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6) ]. In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2 to 4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia. (6.1) In HBV-infected subjects with compensated liver disease: Most common adverse reaction (all grades) was nausea (9%). (6.1) In HBV-infected subjects with decompensated liver disease: Most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia. (6.1) In pediatric subjects: Adverse reactions in pediatric subjects were consistent with those observed in adults.
Source: FDA drug label, Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), via openFDA; the full label on DailyMed
What do FAERS reports show?
32,864 reports list tenofovir disoproxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,940 are coded as a death and 6,381 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (12,182, against a median of 1,322 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tenofovir disoproxil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions