Drug · FAERS side-effect profile with label screen

Lamivudine and Zidovudine side effects: what 7,703 FDA adverse event reports show

Lamivudine And Zidovudine · 294 reaction terms · 16,527 drug–reaction co-reports · data 2026-09-14

Drug class

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Lamivudine (Lamivudine)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

7,703 reports · 90% serious · 594 with death outcome · 52% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LAMIVUDINE is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. LAMIVUDINE is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

FDA label, Indications and Usage

What it is

LAMIVUDINE (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV.

FDA label, Description section

Boxed warning

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE. Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with ste.

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 3Labeled adverse reaction 1Labeled (related wording) 1Reporting / coding artifact 6Lab value / disease marker 4Not in label — unassessed 25

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. 254 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 exposure during pregnancy	1,147	93.6 88.6–98.9ROR 109.8 · χ² 101,629 / p <1e-300	90.4 EB05 86.1 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	serious PRR 62.5	no trial data cached
Abortion induced	188	55.4 48.0–63.9ROR 56.7 · χ² 9,787 / p <1e-300	54.0 EB05 47.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.3 · ♀ 98% (drug 52%)	no trial data cached
Anhedonia	504	52.8 48.5–57.5ROR 56.4 · χ² 25,093 / p <1e-300	51.7 EB05 48.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 35.1 · ♀ 26% (drug 52%) · 100% consumer	no trial data cached
Caesarean section	169	39.7 34.1–46.1ROR 40.5 · χ² 6,243 / p <1e-300	39.0 EB05 34.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.3 · ♀ 76% (drug 52%)	no trial data cached
Economic problem	189	33.8 29.3–38.9ROR 34.6 · χ² 5,910 / p <1e-300	33.3 EB05 29.5 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 22.6 · ♀ 26% (drug 52%) · 100% consumer	no trial data cached
Premature baby	363	33.1 29.9–36.6ROR 34.7 · χ² 11,152 / p <1e-300	32.7 EB05 29.9 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.6	no trial data cached
Osteopenia	178	32.1 27.8–37.2ROR 32.9 · χ² 5,277 / p <1e-300	31.7 EB05 27.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% consumer	no trial data cached
Abortion spontaneous	443	30.3 27.7–33.2ROR 32.1 · χ² 12,404 / p <1e-300	29.9 EB05 27.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · ♀ 100% (drug 52%)	no trial data cached
Pregnancy	194	26.3 22.9–30.3ROR 27.0 · χ² 4,664 / p <1e-300	26.0 EB05 23.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.9 · ♀ 96% (drug 52%)	no trial data cached
Foetal exposure during pregnancy	719	24.3 22.7–26.1ROR 26.7 · χ² 15,955 / p <1e-300	24.1 EB05 22.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.3	no trial data cached
Osteoporosis	269	17.9 15.9–20.1ROR 18.5 · χ² 4,253 / p <1e-300	17.8 EB05 16.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Bone density decreased	195	16.9 14.7–19.4ROR 17.3 · χ² 2,878 / p <1e-300	16.7 EB05 14.8 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious PRR 12.7 · ♀ 31% (drug 52%) · 100% consumer	no trial data cached
End stage renal disease	100	14.9 12.2–18.1ROR 15.0 · χ² 1,272 / p 6e-279	14.7 EB05 12.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 77% consumer	no trial data cached
Premature delivery	84	14.4 11.6–17.8ROR 14.5 · χ² 1,026 / p 2e-225	14.2 EB05 11.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · ♀ 100% (drug 52%)	no trial data cached
Emotional distress	557	12.5 11.6–13.6ROR 13.4 · χ² 5,906 / p <1e-300	12.5 EB05 11.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · ♀ 26% (drug 52%) · 96% consumer	no trial data cached
Hepatomegaly	45	12.5 9.3–16.7ROR 12.5 · χ² 461 / p 2e-102	12.1 EB05 9.3 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.6	no trial data cached
Multiple fractures	72	11.9 9.4–14.9ROR 12.0 · χ² 703 / p 3e-155	11.6 EB05 9.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.1 · ♀ 25% (drug 52%)	no trial data cached
Quality of life decreased	58	11.8 9.1–15.3ROR 11.9 · χ² 560 / p 4e-124	11.5 EB05 9.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · ♀ 27% (drug 52%)	no trial data cached
Maternal exposure during pregnancy	380	11.8 10.7–13.0ROR 12.3 · χ² 3,735 / p <1e-300	11.7 EB05 10.7 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · ♀ 96% (drug 52%)	no trial data cached
Decreased activity	46	11.7 8.8–15.7ROR 11.8 · χ² 439 / p 8e-98	11.4 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · ♀ 13% (drug 52%)	no trial data cached
Chronic kidney disease	327	11.7 10.5–13.0ROR 12.1 · χ² 3,173 / p <1e-300	11.6 EB05 10.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.6 · ♀ 24% (drug 52%) · 78% consumer	no trial data cached
Hyperbilirubinaemia	43	11.4 8.5–15.4ROR 11.5 · χ² 396 / p 2e-88	11.0 EB05 8.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Exposure during pregnancy	257	11.3 10.0–12.7ROR 11.6 · χ² 2,398 / p <1e-300	11.2 EB05 10.1 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.2 · ♀ 100% (drug 52%)	no trial data cached
Hepatitis (liver inflammation)	105	11.2 9.3–13.6ROR 11.3 · χ² 963 / p 9e-212	11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 7.3	no trial data cached
Blood lactate dehydrogenase increased	56	9.6 7.4–12.5ROR 9.7 · χ² 421 / p 7e-94	9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 6.5 · ♀ 16% (drug 52%)	no trial data cached
Ataxia	41	9.4 6.9–12.8ROR 9.4 · χ² 298 / p 4e-67	8.9 EB05 6.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.5 · ♀ 11% (drug 52%)	no trial data cached
Bone loss	52	9.4 7.1–12.3ROR 9.4 · χ² 378 / p 1e-84	8.9 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · ♀ 24% (drug 52%)	no trial data cached
Hypotonia	34	9.3 6.6–13.0ROR 9.3 · χ² 241 / p 9e-55	8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · ♀ 26% (drug 52%)	no trial data cached
Nephropathy	30	8.7 6.1–12.5ROR 8.8 · χ² 197 / p 5e-45	8.0 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.7 · ♀ 27% (drug 52%)	no trial data cached
Drug resistance	82	8.7 7.0–10.8ROR 8.8 · χ² 551 / p 4e-122	8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 5.9	no trial data cached
Jaundice (yellowing of skin/eyes)	80	8.1 6.5–10.1ROR 8.2 · χ² 489 / p 1e-108	7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3	no trial data cached
Hepatotoxicity (liver damage)	65	8.0 6.3–10.2ROR 8.1 · χ² 391 / p 3e-87	7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.1	no trial data cached
Osteonecrosis (bone death)	93	7.7 6.3–9.4ROR 7.7 · χ² 531 / p 1e-117	7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 20% (drug 52%)	no trial data cached
Tooth loss	56	7.3 5.6–9.5ROR 7.4 · χ² 299 / p 3e-67	7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.6 · ♀ 26% (drug 52%)	no trial data cached
Proteinuria	50	7.2 5.5–9.5ROR 7.3 · χ² 262 / p 3e-59	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Blood bilirubin increased	71	7.2 5.7–9.0ROR 7.2 · χ² 369 / p 2e-82	6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 4.9	no trial data cached
Wrist fracture	31	7.1 5.0–10.0ROR 7.1 · χ² 155 / p 8e-36	6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Blood creatine phosphokinase increased	73	6.8 5.4–8.6ROR 6.9 · χ² 355 / p 1e-79	6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 4.7 · ♀ 27% (drug 52%)	no trial data cached
Rash maculo-papular	55	6.8 5.2–8.8ROR 6.8 · χ² 264 / p 1e-59	6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Skeletal injury	25	6.5 4.4–9.6ROR 6.5 · χ² 111 / p 3e-26	5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	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 exposure during pregnancy	1,147	93.6 88.6–98.9ROR 109.8 · χ² 101,629 / p <1e-300	90.4 EB05 86.1 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	serious PRR 62.5	no trial data cached
Foetal exposure during pregnancy	719	24.3 22.7–26.1ROR 26.7 · χ² 15,955 / p <1e-300	24.1 EB05 22.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.3	no trial data cached
Pain	601	2.7 2.5–2.9ROR 2.8 · χ² 639 / p 2e-141	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.6 · ♀ 27% (drug 52%) · 77% consumer	no trial data cached
Anxiety	568	5.4 5.0–5.9ROR 5.8 · χ² 2,071 / p <1e-300	5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · ♀ 27% (drug 52%) · 88% consumer	no trial data cached
Emotional distress	557	12.5 11.6–13.6ROR 13.4 · χ² 5,906 / p <1e-300	12.5 EB05 11.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · ♀ 26% (drug 52%) · 96% consumer	no trial data cached
Anhedonia	504	52.8 48.5–57.5ROR 56.4 · χ² 25,093 / p <1e-300	51.7 EB05 48.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 35.1 · ♀ 26% (drug 52%) · 100% consumer	no trial data cached
Anaemia (low red blood cells)	453	6.5 5.9–7.1ROR 6.8 · χ² 2,105 / p <1e-300	6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5	no trial data cached
Abortion spontaneous	443	30.3 27.7–33.2ROR 32.1 · χ² 12,404 / p <1e-300	29.9 EB05 27.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · ♀ 100% (drug 52%)	no trial data cached
Maternal exposure during pregnancy	380	11.8 10.7–13.0ROR 12.3 · χ² 3,735 / p <1e-300	11.7 EB05 10.7 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · ♀ 96% (drug 52%)	no trial data cached
Premature baby	363	33.1 29.9–36.6ROR 34.7 · χ² 11,152 / p <1e-300	32.7 EB05 29.9 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.6	no trial data cached
Chronic kidney disease	327	11.7 10.5–13.0ROR 12.1 · χ² 3,173 / p <1e-300	11.6 EB05 10.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.6 · ♀ 24% (drug 52%) · 78% consumer	no trial data cached
Pyrexia (fever)	284	2.2 2.0–2.5ROR 2.3 · χ² 195 / p 1e-44	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.7	no trial data cached
Renal failure (kidney failure)	269	5.5 4.9–6.2ROR 5.6 · χ² 986 / p 1e-216	5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.5 · ♀ 28% (drug 52%)	no trial data cached
Osteoporosis	269	17.9 15.9–20.1ROR 18.5 · χ² 4,253 / p <1e-300	17.8 EB05 16.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Depression	267	3.2 2.8–3.6ROR 3.3 · χ² 401 / p 1e-89	3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.7	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.

Abortion induced — n=188, PRR 55.4
Anhedonia — n=504, PRR 52.8
Caesarean section — n=169, PRR 39.7
Premature baby — n=363, PRR 33.1
Osteopenia — n=178, PRR 32.1
Abortion spontaneous — n=443, PRR 30.3
Pregnancy — n=194, PRR 26.3
Osteoporosis — n=269, PRR 17.9
End stage renal disease — n=100, PRR 14.9
Premature delivery — n=84, PRR 14.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zidovudine ↔ Anaemia / bone-marrow suppression.

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 Lamivudine and Zidovudine?

In FDA FAERS, the most frequently co-reported reaction terms for Lamivudine and Zidovudine are pain, anxiety, emotional distress, anhedonia, anaemia, abortion spontaneous. 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 Lamivudine and Zidovudine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE. Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with ste.

Do FAERS signals prove that Lamivudine and Zidovudine 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 47f8be59-178c-4bad-96a4-a5c82784f308, effective 20181224; matched on openfda.generic_name.exact:"LAMIVUDINE")
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, 294 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.