Drug · FAERS side-effect profile with label screen
Tenofovir Disoproxil Fumarate Tablets side effects: what 8,583 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Tenofovir Disoproxil Fumarate Tablets (Tenofovir Disoproxil Fumarate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
8,583 reports · 96% serious · 895 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
FDA label, Indications and Usage
What it is
Tenofovir disoproxil fumarate tablets is the brand name for tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir.
FDA label, Description section
Boxed warning
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 4Labeled adverse reaction 2Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 21
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. 961 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Csf hiv virus identified | 14 | 3,748.3 1,622.8–8,657.6ROR 3,754.4 · χ² 19,082 / p <1e-300 | 486.7 EB05 308.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Csf virus identified | 30 | 1,853.5 1,152.1–2,982.0ROR 1,860.0 · χ² 30,357 / p <1e-300 | 626.5 EB05 460.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · 100% clinician | no trial data cached |
| Progressive external ophthalmoplegia | 50 | 1,525.1 1,070.9–2,171.9ROR 1,534.0 · χ² 45,708 / p <1e-300 | 687.0 EB05 541.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 0% (drug 39%) · 98% clinician | no trial data cached |
| Ultrasound antenatal screen | 33 | 1,303.6 853.9–1,990.0ROR 1,308.6 · χ² 27,034 / p <1e-300 | 566.6 EB05 422.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | no trial data cached |
| Hiv viraemia | 61 | 1,013.7 752.2–1,366.1ROR 1,020.9 · χ² 42,729 / p <1e-300 | 582.6 EB05 469.9 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=61 · 100% clinician | no trial data cached |
| Viral mutation identified | 706 | 575.1 531.3–622.6ROR 626.6 · χ² 326,249 / p <1e-300 | 458.7 EB05 431.0 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=704 · 99% clinician | no trial data cached |
| Virologic failure | 744 | 391.3 363.2–421.5ROR 428.3 · χ² 248,883 / p <1e-300 | 333.8 EB05 314.2 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=740 · 98% clinician | no trial data cached |
| Renal tubular dysfunction | 71 | 356.4 278.0–456.9ROR 359.4 · χ² 21,613 / p <1e-300 | 286.6 EB05 234.9 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=71 · 100% clinician | no trial data cached |
| Csf hiv escape syndrome | 16 | 316.0 187.7–531.9ROR 316.6 · χ² 4,168 / p <1e-300 | 209.8 EB05 136.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 38 | 314.7 224.5–440.9ROR 316.1 · χ² 10,233 / p <1e-300 | 244.3 EB05 185.8 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=38 · 100% clinician | no trial data cached |
| Birth mark | 24 | 314.3 205.5–480.7ROR 315.2 · χ² 6,356 / p <1e-300 | 227.8 EB05 161.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Chronic hepatitis b | 31 | 267.7 184.8–387.8ROR 268.7 · χ² 7,176 / p <1e-300 | 210.0 EB05 155.0 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning exact term | serious n=31 · ♀ 81% (drug 39%) · 90% clinician | no trial data cached |
| Congenital umbilical hernia | 34 | 243.1 171.0–345.7ROR 244.1 · χ² 7,228 / p <1e-300 | 196.6 EB05 147.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=34 · 97% clinician | no trial data cached |
| Fanconi syndrome acquired | 150 | 229.1 194.0–270.4ROR 233.1 · χ² 30,896 / p <1e-300 | 203.8 EB05 177.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=150 · 97% clinician | no trial data cached |
| Human immunodeficiency virus transmission | 22 | 225.6 145.8–349.0ROR 226.2 · χ² 4,295 / p <1e-300 | 175.2 EB05 122.0 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=22 · 100% clinician | no trial data cached |
| Hypophosphataemic osteomalacia | 22 | 223.7 144.6–346.0ROR 224.2 · χ² 4,261 / p <1e-300 | 174.1 EB05 121.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 62% (drug 39%) · 100% clinician | no trial data cached |
| Pathogen resistance | 748 | 218.9 203.7–235.2ROR 239.7 · χ² 148,579 / p <1e-300 | 199.7 EB05 188.0 · IC025 +7.3 3/3 methods agree | Reporting / coding artifact | serious PRR 126.3 · 98% clinician | no trial data cached |
| Hepatitis b dna increased | 52 | 204.1 153.9–270.6ROR 205.3 · χ² 9,501 / p <1e-300 | 176.1 EB05 139.5 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=52 | no trial data cached |
| Genotype drug resistance test positive | 78 | 198.5 157.7–249.8ROR 200.3 · χ² 13,978 / p <1e-300 | 175.6 EB05 145.3 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=77 · 96% clinician | no trial data cached |
| Hemivertebra | 12 | 184.2 102.4–331.1ROR 184.4 · χ² 1,864 / p <1e-300 | 135.0 EB05 82.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Blood hiv rna increased | 120 | 175.2 145.8–210.7ROR 177.7 · χ² 19,220 / p <1e-300 | 159.3 EB05 136.8 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=120 · 93% clinician | no trial data cached |
| Fanconi syndrome | 94 | 175.2 142.2–215.7ROR 177.1 · χ² 15,015 / p <1e-300 | 158.2 EB05 133.1 · IC025 +6.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=93 · 98% clinician | no trial data cached |
| Mitochondrial toxicity | 54 | 171.7 130.4–226.1ROR 172.7 · χ² 8,394 / p <1e-300 | 151.8 EB05 120.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 0% (drug 39%) · 96% clinician | no trial data cached |
| Trisomy 18 | 20 | 134.2 85.6–210.5ROR 134.6 · χ² 2,381 / p <1e-300 | 113.7 EB05 77.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Brachydactyly | 10 | 131.0 69.3–247.4ROR 131.1 · χ² 1,103 / p 4e-242 | 100.9 EB05 58.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hydrops foetalis | 31 | 130.4 90.9–187.0ROR 130.8 · χ² 3,654 / p <1e-300 | 115.1 EB05 85.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | no trial data cached |
| Lipodystrophy acquired | 105 | 126.4 104.0–153.7ROR 128.0 · χ² 12,298 / p <1e-300 | 117.7 EB05 100.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 13% (drug 39%) | no trial data cached |
| Immune reconstitution inflammatory syndrome | 217 | 110.7 96.8–126.6ROR 113.5 · χ² 22,452 / p <1e-300 | 104.9 EB05 93.7 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=216 · 96% clinician | no trial data cached |
| Immune reconstitution syndrome | 55 | 107.2 81.9–140.4ROR 107.9 · χ² 5,440 / p <1e-300 | 99.2 EB05 79.1 · IC025 +5.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=54 | no trial data cached |
| Gene mutation identification test positive | 17 | 101.6 62.6–165.1ROR 101.8 · χ² 1,530 / p <1e-300 | 88.2 EB05 58.3 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Macrocephaly | 14 | 92.9 54.5–158.4ROR 93.1 · χ² 1,139 / p 6e-250 | 80.1 EB05 50.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Hiv test positive | 24 | 91.1 60.6–136.8ROR 91.3 · χ² 1,974 / p <1e-300 | 82.2 EB05 58.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=24 · 100% clinician | no trial data cached |
| Meningomyelocele | 21 | 87.5 56.7–135.2ROR 87.8 · χ² 1,651 / p <1e-300 | 78.7 EB05 54.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% clinician | no trial data cached |
| Glycosuria | 45 | 84.1 62.5–113.1ROR 84.5 · χ² 3,489 / p <1e-300 | 78.6 EB05 61.2 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=45 · 100% clinician | no trial data cached |
| Hepatitis b | 201 | 83.7 72.9–96.2ROR 85.7 · χ² 15,804 / p <1e-300 | 80.4 EB05 71.5 · IC025 +5.8 3/3 methods agree | Labeled — boxed warning exact term | serious n=200 | no trial data cached |
| Extraocular muscle paresis | 14 | 75.8 44.6–129.0ROR 75.9 · χ² 931 / p 1e-204 | 67.1 EB05 42.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Renal tubular disorder | 84 | 74.7 60.2–92.7ROR 75.4 · χ² 5,851 / p <1e-300 | 71.3 EB05 59.4 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=84 · 99% clinician | no trial data cached |
| Congenital hydrocephalus | 15 | 73.6 44.1–123.0ROR 73.7 · χ² 973 / p 6e-214 | 65.8 EB05 42.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Spine malformation | 10 | 71.5 38.1–134.1ROR 71.6 · χ² 608 / p 1e-134 | 61.7 EB05 35.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Osteomalacia | 43 | 69.3 51.2–93.7ROR 69.6 · χ² 2,746 / p <1e-300 | 65.5 EB05 50.6 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=43 · ♀ 17% (drug 39%) · 90% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Pathogen resistance | 748 | 218.9 203.7–235.2ROR 239.7 · χ² 148,579 / p <1e-300 | 199.7 EB05 188.0 · IC025 +7.3 3/3 methods agree | Reporting / coding artifact | serious PRR 126.3 · 98% clinician | no trial data cached |
| Virologic failure | 744 | 391.3 363.2–421.5ROR 428.3 · χ² 248,883 / p <1e-300 | 333.8 EB05 314.2 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=740 · 98% clinician | no trial data cached |
| Foetal exposure during pregnancy | 711 | 21.6 20.1–23.1ROR 23.4 · χ² 13,850 / p <1e-300 | 21.4 EB05 20.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 · 94% clinician | no trial data cached |
| Viral mutation identified | 706 | 575.1 531.3–622.6ROR 626.6 · χ² 326,249 / p <1e-300 | 458.7 EB05 431.0 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=704 · 99% clinician | no trial data cached |
| Drug resistance | 500 | 48.5 44.5–52.8ROR 51.4 · χ² 22,776 / p <1e-300 | 47.5 EB05 44.1 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 31.7 · 93% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 437 | 0.8 0.7–0.9ROR 0.8 · χ² 20 / p 3e-6 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Maternal exposure during pregnancy | 389 | 10.8 9.8–11.9ROR 11.3 · χ² 3,455 / p <1e-300 | 10.7 EB05 9.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 98% (drug 39%) | no trial data cached |
| Drug interaction | 340 | 5.2 4.7–5.8ROR 5.4 · χ² 1,170 / p 1e-256 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 92% clinician | no trial data cached |
| Treatment failure | 300 | 9.0 8.0–10.0ROR 9.2 · χ² 2,113 / p <1e-300 | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 97% clinician | no trial data cached |
| Abortion spontaneous | 266 | 16.3 14.4–18.3ROR 16.7 · χ² 3,774 / p <1e-300 | 16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 97% (drug 39%) · 95% clinician | no trial data cached |
| Death | 252 | 0.7 0.6–0.8ROR 0.7 · χ² 30 / p 3e-8 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.4 | no trial data cached |
| Exposure during pregnancy | 240 | 9.5 8.3–10.7ROR 9.7 · χ² 1,806 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · ♀ 97% (drug 39%) | no trial data cached |
| Osteoporosis | 240 | 14.3 12.6–16.2ROR 14.7 · χ² 2,947 / p <1e-300 | 14.2 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.8 | no trial data cached |
| Renal impairment | 227 | 6.6 5.8–7.6ROR 6.8 · χ² 1,084 / p 6e-238 | 6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 | no trial data cached |
| Immune reconstitution inflammatory syndrome | 217 | 110.7 96.8–126.6ROR 113.5 · χ² 22,452 / p <1e-300 | 104.9 EB05 93.7 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=216 · 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.
- Progressive external ophthalmoplegia — n=50, PRR 1,525.1
- Ultrasound antenatal screen — n=33, PRR 1,303.6
- Hiv viraemia — n=61, PRR 1,013.7
- Viral mutation identified — n=706, PRR 575.1
- Virologic failure — n=744, PRR 391.3
- Birth mark — n=24, PRR 314.3
- Congenital umbilical hernia — n=34, PRR 243.1
- Fanconi syndrome acquired — n=150, PRR 229.1
- Hypophosphataemic osteomalacia — n=22, PRR 223.7
- Mitochondrial toxicity — n=54, PRR 171.7
✓ 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 Disoproxil?
In FDA FAERS, the most frequently co-reported reaction terms for Tenofovir Disoproxil are virologic failure, viral mutation identified, abortion spontaneous, osteoporosis, renal impairment, immune reconstitution inflammatory syndrome. 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 Disoproxil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate.
Do FAERS signals prove that Tenofovir Disoproxil 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 9cf11bd3-01b9-4ac8-96cc-55d57998b51d, effective 20221212; matched on
openfda.generic_name.exact:"TENOFOVIR DISOPROXIL FUMARATE TABLETS") - 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, 1,001 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.