Tenofovir Alafenamide side effects: what 4,059 FDA adverse event reports show
Drug class
Hepatitis b virus (hbv) nucleoside analog reverse transcriptase inhibitor and is
Brand names
Vemlidy
Who reports
4,059 reports · 71% serious · 431 with death outcome · 39% female
Used for
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease . VEMLIDY is a hepatit.
What it is
VEMLIDY is a tablet containing tenofovir alafenamide for oral administration. Tenofovir alafenamide, a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.
Boxed warning
POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored clo.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 69 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Intentional dose omission | 69 | 13.1 10.3–16.5ROR 13.3 · χ² 755 / p 1e-166 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 88% consumer | no trial data cached |
| Hepatic cancer | 49 | 10.4 7.9–13.8ROR 10.6 · χ² 409 / p 4e-91 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Drug resistance | 46 | 9.3 6.9–12.3ROR 9.4 · χ² 331 / p 4e-74 | 8.8 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Hepatic cirrhosis | 28 | 7.7 5.4–11.2ROR 7.8 · χ² 158 / p 2e-36 | 7.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Dialysis | 18 | 6.5 4.1–10.4ROR 6.6 · χ² 79 / p 3e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Osteoporosis | 52 | 6.5 5.0–8.6ROR 6.6 · χ² 238 / p 5e-54 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Product dispensing error | 24 | 5.7 3.8–8.5ROR 5.7 · χ² 88 / p 3e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=11 · 91% clinician | no trial data cached |
| Glomerular filtration rate decreased | 13 | 5.5 3.2–9.5ROR 5.6 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 4.3 | no trial data cached |
| Product dose omission | 71 | 5.5 4.4–7.0ROR 5.6 · χ² 260 / p 8e-59 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 81% consumer | no trial data cached |
| Hepatic encephalopathy | 10 | 5.5 3.0–10.3ROR 5.5 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Neoplasm malignant | 68 | 5.3 4.2–6.7ROR 5.3 · χ² 231 / p 1e-52 | 5.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 72% consumer | no trial data cached |
| Transaminases increased | 22 | 5.1 3.4–7.8ROR 5.1 · χ² 69 / p 5e-17 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Osteopenia | 15 | 5.1 3.1–8.4ROR 5.1 · χ² 45 / p 9e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Cytopenia | 11 | 4.8 2.6–8.6ROR 4.8 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Economic problem | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 6e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Anhedonia | 23 | 4.5 3.0–6.7ROR 4.5 · χ² 59 / p 8e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hepatic failure | 26 | 4.4 3.0–6.5ROR 4.5 · χ² 66 / p 2e-16 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Liver disorder | 38 | 4.4 3.2–6.1ROR 4.5 · χ² 98 / p 2e-23 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.8 · ♀ 59% (drug 39%) | no trial data cached |
| Product dose omission in error | 23 | 4.4 2.9–6.7ROR 4.4 · χ² 58 / p 2e-14 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Alanine aminotransferase increased | 52 | 4.4 3.3–5.7ROR 4.4 · χ² 132 / p 7e-31 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Liver function test increased | 17 | 4.1 2.6–6.6ROR 4.1 · χ² 37 / p 6e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Treatment noncompliance | 43 | 4.1 3.0–5.5ROR 4.1 · χ² 97 / p 3e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 95% clinician | no trial data cached |
| Renal impairment | 65 | 4.0 3.2–5.1ROR 4.1 · χ² 145 / p 1e-33 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.1 | no trial data cached |
| Renal disorder | 36 | 4.0 2.9–5.5ROR 4.0 · χ² 78 / p 6e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| End stage renal disease | 14 | 3.9 2.3–6.6ROR 3.9 · χ² 28 / p 7e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Hepatic function abnormal | 28 | 3.9 2.7–5.6ROR 3.9 · χ² 58 / p 2e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Proteinuria | 13 | 3.6 2.1–6.1ROR 3.6 · χ² 21 / p 2e-6 | 3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Foetal exposure during pregnancy | 54 | 3.4 2.6–4.5ROR 3.5 · χ² 91 / p 7e-22 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 91% clinician | no trial data cached |
| Cerebral infarction | 16 | 3.4 2.1–5.5ROR 3.4 · χ² 24 / p 4e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Maternal exposure during pregnancy | 56 | 3.3 2.5–4.3ROR 3.3 · χ² 87 / p 6e-21 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · ♀ 100% (drug 39%) | no trial data cached |
| Fracture | 12 | 3.3 1.9–5.8ROR 3.3 · χ² 17 / p 2e-5 | 3.0 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Product dose omission issue | 178 | 3.2 2.8–3.7ROR 3.3 · χ² 275 / p 4e-62 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 90% consumer | no trial data cached |
| Liver injury | 15 | 3.2 1.9–5.3ROR 3.2 · χ² 21 / p 3e-6 | 3.0 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Chronic kidney disease | 47 | 3.2 2.4–4.2ROR 3.2 · χ² 68 / p 9e-17 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 · ♀ 19% (drug 39%) · 96% clinician | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 16 | 3.1 1.9–5.0ROR 3.1 · χ² 20 / p 3e-6 | 2.9 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Dementia | 16 | 3.0 1.8–4.8ROR 3.0 · χ² 19 / p 7e-6 | 2.8 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Drug eruption | 10 | 2.9 1.6–5.4ROR 2.9 · χ² 11 / p 5e-4 | 2.7 EB05 1.6 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Drug interaction | 88 | 2.9 2.3–3.5ROR 2.9 · χ² 106 / p 4e-25 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 95% clinician | no trial data cached |
| Cardiovascular disorder | 14 | 2.8 1.7–4.8ROR 2.8 · χ² 15 / p 6e-5 | 2.6 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 10 | 2.8 1.5–5.2ROR 2.8 · χ² 10 / p 9e-4 | 2.6 EB05 1.5 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 251 | 1.5 1.3–1.7ROR 1.5 · χ² 44 / p 2e-11 | 1.5 EB05 1.4 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Product dose omission issue | 178 | 3.2 2.8–3.7ROR 3.3 · χ² 275 / p 4e-62 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 90% consumer | no trial data cached |
| Drug interaction | 88 | 2.9 2.3–3.5ROR 2.9 · χ² 106 / p 4e-25 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 95% clinician | no trial data cached |
| Product use issue | 83 | 2.3 1.9–2.8ROR 2.3 · χ² 60 / p 5e-15 | 2.3 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.3 · 83% consumer | no trial data cached |
| Product dose omission | 71 | 5.5 4.4–7.0ROR 5.6 · χ² 260 / p 8e-59 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 81% consumer | no trial data cached |
| Intentional dose omission | 69 | 13.1 10.3–16.5ROR 13.3 · χ² 755 / p 1e-166 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 88% consumer | no trial data cached |
| Neoplasm malignant | 68 | 5.3 4.2–6.7ROR 5.3 · χ² 231 / p 1e-52 | 5.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 72% consumer | no trial data cached |
| Renal impairment | 65 | 4.0 3.2–5.1ROR 4.1 · χ² 145 / p 1e-33 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.1 | no trial data cached |
| Maternal exposure during pregnancy | 56 | 3.3 2.5–4.3ROR 3.3 · χ² 87 / p 6e-21 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · ♀ 100% (drug 39%) | no trial data cached |
| Foetal exposure during pregnancy | 54 | 3.4 2.6–4.5ROR 3.5 · χ² 91 / p 7e-22 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 91% clinician | no trial data cached |
| Alanine aminotransferase increased | 52 | 4.4 3.3–5.7ROR 4.4 · χ² 132 / p 7e-31 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Osteoporosis | 52 | 6.5 5.0–8.6ROR 6.6 · χ² 238 / p 5e-54 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Dysphagia (difficulty swallowing) | 49 | 2.7 2.0–3.5ROR 2.7 · χ² 50 / p 8e-13 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 92% clinician | no trial data cached |
| Hepatic cancer | 49 | 10.4 7.9–13.8ROR 10.6 · χ² 409 / p 4e-91 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Chronic kidney disease | 47 | 3.2 2.4–4.2ROR 3.2 · χ² 68 / p 9e-17 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 · ♀ 19% (drug 39%) · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hepatic cancer — n=49, PRR 10.4
- Hepatic cirrhosis — n=28, PRR 7.7
- Neoplasm malignant — n=68, PRR 5.3
- Transaminases increased — n=22, PRR 5.1
- Anhedonia — n=23, PRR 4.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tenofovir Alafenamide?
In FDA FAERS, the most frequently co-reported reaction terms for Tenofovir Alafenamide are neoplasm malignant, renal impairment, alanine aminotransferase increased, osteoporosis, dysphagia, hepatic cancer. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tenofovir Alafenamide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored clo.
Do FAERS signals prove that Tenofovir Alafenamide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 72e6b33c-0351-4070-9172-eeaa186c01d2, effective 20250714; matched on
openfda.generic_name.exact:"TENOFOVIR ALAFENAMIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 109 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.