Adefovir Dipivoxil side effects: what 1,270 FDA adverse event reports show

Adefovir Dipivoxil · 51 reaction terms · 1,427 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,270 reports · 99% serious · 68 with death outcome · 26% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Adefovir Dipivoxil Tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

FDA label, Indications and Usage

What it is

Adefovir dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV).

FDA label, Description section

Boxed warning

SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including Adefovir Dipivoxil Tablets.

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 34 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 2Labeled (related wording) 5Reporting / coding artifact 3Lab value / disease marker 4Not in label — unassessed 17

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.
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. 17 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug resistance	275	178.6 160.7–198.4ROR 227.6 · χ² 47,911 / p <1e-300	174.5 EB05 157.9 · IC025 +6.9 3/3 methods agree	Reporting / coding artifact	serious PRR 114.9	no trial data cached
Osteoporosis	154	61.9 53.4–71.8ROR 70.3 · χ² 9,153 / p <1e-300	61.2 EB05 53.5 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 41.6 · 99% clinician	no trial data cached
Nephropathy toxic	37	55.0 40.0–75.6ROR 56.6 · χ² 1,902 / p <1e-300	53.4 EB05 40.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.7 · 100% clinician	no trial data cached
Blood alkaline phosphatase increased	64	42.5 33.5–54.0ROR 44.8 · χ² 2,552 / p <1e-300	41.9 EB05 34.0 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 28.1 · 95% clinician	no trial data cached
Hepatic cirrhosis	40	35.4 26.1–48.0ROR 36.5 · χ² 1,301 / p 4e-285	34.8 EB05 26.6 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.8	no trial data cached
Bone pain	118	33.3 28.0–39.5ROR 36.6 · χ² 3,663 / p <1e-300	33.0 EB05 28.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.4 · 98% clinician	no trial data cached
Proteinuria	31	27.2 19.2–38.5ROR 27.8 · χ² 755 / p 2e-166	26.7 EB05 19.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached
Glomerular filtration rate decreased	19	25.9 16.6–40.5ROR 26.3 · χ² 430 / p 8e-96	25.3 EB05 17.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 18.7	no trial data cached
Hepatic encephalopathy	14	24.8 14.7–41.7ROR 25.0 · χ² 296 / p 1e-66	23.9 EB05 15.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Musculoskeletal chest pain	21	22.4 14.6–34.2ROR 22.8 · χ² 408 / p 6e-91	21.9 EB05 15.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.6 · 100% clinician	no trial data cached
Hepatic failure	37	20.2 14.7–27.8ROR 20.8 · χ² 657 / p 3e-145	20.0 EB05 15.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.8	no trial data cached
Bone density decreased	36	18.8 13.6–25.9ROR 19.3 · χ² 588 / p 3e-130	18.6 EB05 14.0 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.7 · 94% clinician	no trial data cached
Multiple fractures	18	17.9 11.3–28.4ROR 18.2 · χ² 271 / p 3e-61	17.4 EB05 11.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Nephropathy	10	17.6 9.5–32.6ROR 17.7 · χ² 140 / p 1e-32	16.2 EB05 8.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Tenderness	11	17.4 9.7–31.3ROR 17.5 · χ² 154 / p 1e-35	16.2 EB05 8.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Blood creatine phosphokinase increased	30	16.9 11.9–24.1ROR 17.3 · χ² 434 / p 1e-96	16.7 EB05 12.1 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 11.0	no trial data cached
Rib fracture	20	16.1 10.4–24.9ROR 16.3 · χ² 268 / p 1e-60	15.6 EB05 10.3 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2 · 95% clinician	no trial data cached
Liver injury	19	13.0 8.3–20.3ROR 13.2 · χ² 198 / p 3e-45	12.1 EB05 7.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Ascites	21	11.8 7.7–18.0ROR 12.0 · χ² 197 / p 5e-45	10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Renal impairment	59	11.6 9.1–14.9ROR 12.2 · χ² 565 / p 3e-125	11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 7.0 · 93% clinician	no trial data cached
Metabolic acidosis	22	11.5 7.6–17.4ROR 11.7 · χ² 200 / p 1e-45	10.6 EB05 7.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · 100% clinician	no trial data cached
Blood creatinine increased	43	10.9 8.1–14.6ROR 11.2 · χ² 376 / p 6e-84	10.4 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.9 · ♀ 5% (drug 26%) · 98% clinician	no trial data cached
Renal injury	19	10.4 6.7–16.3ROR 10.6 · χ² 153 / p 2e-35	9.4 EB05 6.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Treatment failure	51	10.3 7.8–13.4ROR 10.6 · χ² 418 / p 3e-93	9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.5 · 100% clinician	no trial data cached
Alanine aminotransferase increased	35	9.4 6.8–13.0ROR 9.6 · χ² 255 / p 1e-57	8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.3 · 91% clinician	no trial data cached
Hepatic function abnormal	20	8.9 5.8–13.8ROR 9.0 · χ² 133 / p 5e-31	7.9 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6	no trial data cached
Hepatic cancer	13	8.8 5.1–15.2ROR 8.9 · χ² 83 / p 5e-20	7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Fracture	10	8.7 4.7–16.2ROR 8.8 · χ² 61 / p 3e-15	6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.6	no trial data cached
Hepatitis (liver inflammation)	13	8.4 4.9–14.4ROR 8.5 · χ² 77 / p 7e-19	6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.0	no trial data cached
Transaminases increased	11	8.2 4.5–14.7ROR 8.2 · χ² 62 / p 1e-15	6.5 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Intervertebral disc protrusion	10	7.5 4.1–14.0ROR 7.6 · χ² 50 / p 7e-13	5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Treatment noncompliance	24	7.3 4.9–10.8ROR 7.4 · χ² 124 / p 4e-29	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached
Jaundice (yellowing of skin/eyes)	11	6.7 3.7–12.1ROR 6.8 · χ² 48 / p 2e-12	5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Osteonecrosis (bone death)	13	6.5 3.8–11.1ROR 6.5 · χ² 55 / p 6e-14	5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	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
Drug resistance	275	178.6 160.7–198.4ROR 227.6 · χ² 47,911 / p <1e-300	174.5 EB05 157.9 · IC025 +6.9 3/3 methods agree	Reporting / coding artifact	serious PRR 114.9	no trial data cached
Osteoporosis	154	61.9 53.4–71.8ROR 70.3 · χ² 9,153 / p <1e-300	61.2 EB05 53.5 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 41.6 · 99% clinician	no trial data cached
Bone pain	118	33.3 28.0–39.5ROR 36.6 · χ² 3,663 / p <1e-300	33.0 EB05 28.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.4 · 98% clinician	no trial data cached
Blood alkaline phosphatase increased	64	42.5 33.5–54.0ROR 44.8 · χ² 2,552 / p <1e-300	41.9 EB05 34.0 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 28.1 · 95% clinician	no trial data cached
Renal impairment	59	11.6 9.1–14.9ROR 12.2 · χ² 565 / p 3e-125	11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 7.0 · 93% clinician	no trial data cached
Treatment failure	51	10.3 7.8–13.4ROR 10.6 · χ² 418 / p 3e-93	9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.5 · 100% clinician	no trial data cached
Blood creatinine increased	43	10.9 8.1–14.6ROR 11.2 · χ² 376 / p 6e-84	10.4 EB05 7.9 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.9 · ♀ 5% (drug 26%) · 98% clinician	no trial data cached
Hepatic cirrhosis	40	35.4 26.1–48.0ROR 36.5 · χ² 1,301 / p 4e-285	34.8 EB05 26.6 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.8	no trial data cached
Hepatic failure	37	20.2 14.7–27.8ROR 20.8 · χ² 657 / p 3e-145	20.0 EB05 15.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.8	no trial data cached
Nephropathy toxic	37	55.0 40.0–75.6ROR 56.6 · χ² 1,902 / p <1e-300	53.4 EB05 40.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.7 · 100% clinician	no trial data cached
Bone density decreased	36	18.8 13.6–25.9ROR 19.3 · χ² 588 / p 3e-130	18.6 EB05 14.0 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 13.7 · 94% clinician	no trial data cached
Alanine aminotransferase increased	35	9.4 6.8–13.0ROR 9.6 · χ² 255 / p 1e-57	8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.3 · 91% clinician	no trial data cached
Proteinuria	31	27.2 19.2–38.5ROR 27.8 · χ² 755 / p 2e-166	26.7 EB05 19.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.7	no trial data cached
Blood creatine phosphokinase increased	30	16.9 11.9–24.1ROR 17.3 · χ² 434 / p 1e-96	16.7 EB05 12.1 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 11.0	no trial data cached
Treatment noncompliance	24	7.3 4.9–10.8ROR 7.4 · χ² 124 / p 4e-29	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	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.

Osteoporosis — n=154, PRR 61.9
Nephropathy toxic — n=37, PRR 55.0
Proteinuria — n=31, PRR 27.2
Musculoskeletal chest pain — n=21, PRR 22.4
Ascites — n=21, PRR 11.8
Metabolic acidosis — n=22, PRR 11.5

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 Adefovir Dipivoxil?

In FDA FAERS, the most frequently co-reported reaction terms for Adefovir Dipivoxil are osteoporosis, bone pain, blood alkaline phosphatase increased, renal impairment, blood creatinine increased, hepatic cirrhosis. 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 Adefovir Dipivoxil have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including Adefovir Dipivoxil Tablets.

Do FAERS signals prove that Adefovir Dipivoxil 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 e047f3b2-feae-4c5e-9d07-1fefb4c0ec25, effective 20230324; matched on openfda.generic_name.exact:"ADEFOVIR DIPIVOXIL")
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, field patient.drug.openfda.generic_name.exact, 51 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.