What the label lists and what reports show
Tenofovir alafenamide side effects
Tenofovir alafenamide's FDA label: “Most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache.” FAERS holds 4,061 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 fatigue (141 reports).
- No generic listed
- Boxed warning
Check it at the source: the tenofovir alafenamide FDA label on DailyMed (effective July 14, 2025, Gilead Sciences, Inc.); 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 VEMLIDY?VEMLIDY may cause serious side effects, including: See " What is the most important information I should know about VEMLIDY? " New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting and during treatment with VEMLIDY. Your healthcare provider may tell you to stop taking VEMLIDY if you develop new or worse kidney problems. Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems. […]
Source: FDA drug label, Gilead Sciences, Inc., effective July 14, 2025 (SPL set 72e6b33c-0351-4070-9172-eeaa186c01d2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence greater than or equal to 10%, all grades) is headache.
Table 1 Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. (All Grades) Reported in ≥5% of Subjects with Chronic HBV…
| Reaction | VEMLIDY (N=866) | TDF (N=432) |
|---|---|---|
| Headache | 12% | 10% |
| Abdominal pain Grouped term including abdominal pain upper, abdominal pain, abdominal… | 9% | 6% |
| Cough | 8% | 8% |
| Back pain | 6% | 6% |
| Fatigue | 6% | 5% |
| Nausea | 6% | 6% |
| Arthralgia | 5% | 6% |
| Diarrhea | 5% | 5% |
| Dyspepsia | 5% | 5% |
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 [see Warnings and Precautions (5.1) ] New Onset or Worsening of Renal Impairment [see Warnings and Precautions (5.3) ] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.4) ] Most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult Subjects with Chronic Hepatitis B and Compensated Liver Disease The safety assessment of VEMLIDY was based on pooled data through the Week 96 data analysis from 1298 subjects in two randomized, double-blind, active-controlled trials, Trial 108 and Trial 110, in adult subjects with chronic hepatitis B and compensated liver disease. A total of 866 subjects received VEMLIDY 25 mg once daily [see Clinical Studies (14.2) ].
Source: FDA drug label, Gilead Sciences, Inc., effective July 14, 2025 (SPL set 72e6b33c-0351-4070-9172-eeaa186c01d2), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,061 reports list tenofovir alafenamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 431 are coded as a death and 1,162 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. Of the 14 reactions below, 6 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 alafenamide: 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