Drug · FAERS side-effect profile with label screen
Lamivudine side effects: what 25,150 FDA adverse event reports show
Drug class
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
25,150 reports · 97% serious · 3,540 with death outcome · 38% 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 (related wording) 3Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 27
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 (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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,154 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 |
|---|---|---|---|---|---|---|
| Pinealoblastoma | 75 | 2,802.7 1,675.8–4,687.5ROR 2,809.6 · calibrated p 1e-20 ✓ | 476.9 EB05 393.0 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.7–3.3) | Not in label — unassessed | serious n=74 · ♀ 0% (drug 38%) | no trial arm names this drug |
| Progressive external ophthalmoplegia | 101 | 2,426.4 1,596.7–3,687.2ROR 2,434.4 · calibrated p 1e-20 ✓ | 479.3 EB05 405.9 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.1) | Not in label — unassessed | serious n=101 · ♀ 0% (drug 38%) · 93% clinician | no trial arm names this drug |
| Csf hiv virus identified | 18 | 2,421.6 899.1–6,522.0ROR 2,423.0 · calibrated p 2e-15 ✓ | 337.7 EB05 226.0 · IC025 +4.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.2–4.6) | Labeled (related wording) related wording | serious n=18 | no trial arm names this drug |
| Congenital neoplasm | 21 | 2,354.3 950.3–5,832.7ROR 2,355.9 · calibrated p 4e-16 ✓ | 354.4 EB05 244.6 · IC025 +4.6 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.3–4.3) | Not in label — unassessed | serious n=21 | no trial arm names this drug |
| Genotype drug resistance test | 34 | 1,524.7 830.6–2,798.9ROR 1,526.4 · calibrated p 8e-17 ✓ | 369.9 EB05 276.8 · IC025 +5.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.3 (0.8–1.9) | Reporting / coding artifact | serious n=33 · ♀ 0% (drug 38%) · 100% clinician | no trial arm names this drug |
| Csf hiv escape syndrome | 83 | 1,015.1 722.1–1,427.0ROR 1,017.8 · calibrated p 1e-16 ✓ | 370.5 EB05 308.3 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.2) | Not in label — unassessed | serious n=83 · 100% clinician | no trial arm names this drug |
| Hiv viraemia | 115 | 850.1 645.8–1,118.9ROR 853.3 · calibrated p 5e-16 ✓ | 353.9 EB05 302.8 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.1) | Not in label — unassessed | serious n=115 · 100% clinician | no trial arm names this drug |
| Ultrasound antenatal screen | 50 | 764.4 509.8–1,146.0ROR 765.6 · calibrated p 6e-15 ✓ | 315.1 EB05 248.4 · IC025 +5.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.6–3.6) | Not in label — unassessed | serious n=49 · 100% clinician | no trial arm names this drug |
| Immune reconstitution syndrome | 626 | 633.2 568.1–705.8ROR 646.4 · calibrated p 4e-15 ✓ | 323.4 EB05 302.7 · IC025 +7.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 3.0 (2.6–3.3) | Labeled — boxed warning exact term | serious n=499 | no trial arm names this drug |
| Human immunodeficiency virus transmission | 119 | 580.0 454.0–741.0ROR 582.3 · calibrated p 3e-14 ✓ | 297.0 EB05 254.9 · IC025 +6.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.9–3.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=118 · 100% clinician | no trial arm names this drug |
| Viral mutation identified | 1,670 | 563.4 528.4–600.6ROR 595.7 · calibrated p 9e-15 ✓ | 306.0 EB05 293.8 · IC025 +8.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.4) | Not in label — unassessed | serious n=1,650 · 98% clinician | no trial arm names this drug |
| Aids encephalopathy | 25 | 509.6 303.1–856.8ROR 510.0 · calibrated p 1e-12 ✓ | 237.7 EB05 169.3 · IC025 +4.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 3.1 (1.7–5.7) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Genetic polymorphism | 24 | 489.2 289.2–827.6ROR 489.6 · calibrated p 2e-12 ✓ | 231.5 EB05 163.7 · IC025 +4.7 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.3–4.2) | Not in label — unassessed | serious n=24 | no trial arm names this drug |
| Hiv associated nephropathy | 20 | 448.4 254.7–789.5ROR 448.7 · calibrated p 7e-12 ✓ | 214.5 EB05 146.6 · IC025 +4.4 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.1 (1.1–3.8) | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Total lung capacity increased | 101 | 402.0 314.3–514.3ROR 403.3 · calibrated p 1e-12 ✓ | 240.5 EB05 203.7 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.1) | Not in label — unassessed | serious n=101 · ♀ 100% (drug 38%) · 94% clinician | no trial arm names this drug |
| Virologic failure | 1,957 | 390.7 370.0–412.7ROR 417.3 · calibrated p 4e-13 ✓ | 246.9 EB05 237.9 · IC025 +7.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (2.3–2.6) | Not in label — unassessed | serious n=1,892 · 98% clinician | no trial arm names this drug |
| Aids related complication | 22 | 344.1 205.9–575.2ROR 344.4 · calibrated p 4e-11 ✓ | 190.5 EB05 132.6 · IC025 +4.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.9 (1.6–5.4) | Reporting / coding artifact | serious n=18 | no trial arm names this drug |
| Hiv-associated neurocognitive disorder | 33 | 284.6 189.5–427.5ROR 284.9 · calibrated p 9e-11 ✓ | 179.6 EB05 133.8 · IC025 +5.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.5–3.8) | Not in label — unassessed | serious n=33 | no trial arm names this drug |
| Mitochondrial toxicity | 234 | 272.3 234.0–316.9ROR 274.4 · calibrated p 3e-11 ✓ | 191.1 EB05 171.4 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.6 (2.1–3.1) | Not in label — unassessed | serious n=216 · ♀ 17% (drug 38%) | no trial arm names this drug |
| Lipodystrophy acquired | 552 | 238.9 217.0–263.1ROR 243.3 · calibrated p 7e-11 ✓ | 175.5 EB05 163.6 · IC025 +7.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.8 (2.4–3.1) | Not in label — unassessed | serious n=474 | no trial arm names this drug |
| Birth mark | 53 | 230.0 168.4–314.1ROR 230.4 · calibrated p 3e-10 ✓ | 161.7 EB05 128.4 · IC025 +5.6 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.6–3.5) | Not in label — unassessed | serious n=53 · 96% clinician | no trial arm names this drug |
| Ectopic kidney | 23 | 224.2 139.9–359.4ROR 224.4 · calibrated p 1e-9 ✓ | 148.0 EB05 103.8 · IC025 +4.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.5 (1.4–4.5) | Not in label — unassessed | serious n=22 | no trial arm names this drug |
| Hepatitis b virus | 20 | 220.5 133.1–365.4ROR 220.7 · calibrated p 2e-9 ✓ | 143.8 EB05 98.3 · IC025 +4.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 3.2 (1.6–6.2) | Labeled — boxed warning exact term | serious n=15 | no trial arm names this drug |
| Blood hiv rna increased | 419 | 208.6 187.1–232.6ROR 211.5 · calibrated p 3e-10 ✓ | 158.3 EB05 146.0 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.5 (2.2–2.9) | Lab value / disease marker | serious n=390 · 98% clinician | no trial arm names this drug |
| Congenital teratoma | 20 | 207.0 125.4–341.6ROR 207.1 · calibrated p 3e-9 ✓ | 137.9 EB05 94.3 · IC025 +4.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.3–4.4) | Not in label — unassessed | serious n=20 | no trial arm names this drug |
| Retinoblastoma | 25 | 202.6 129.6–316.8ROR 202.8 · calibrated p 2e-9 ✓ | 139.5 EB05 99.4 · IC025 +4.6 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 3.1 (1.7–5.7) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 73 | 191.8 147.9–248.7ROR 192.3 · calibrated p 1e-9 ✓ | 143.9 EB05 118.3 · IC025 +5.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.5 (1.8–3.4) | Labeled (related wording) related wording | serious n=70 · 100% clinician | no trial arm names this drug |
| Hepatitis b dna increased | 145 | 187.2 155.8–225.0ROR 188.1 · calibrated p 9e-10 ✓ | 143.9 EB05 125.3 · IC025 +6.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.2 (1.0–1.5) | Lab value / disease marker | serious n=139 · 91% clinician | no trial arm names this drug |
| Pathogen resistance | 1,770 | 165.1 156.9–173.7ROR 175.1 · calibrated p 1e-9 ✓ | 132.5 EB05 127.4 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.4) | Reporting / coding artifact | serious PRR 99.2 · 98% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 101 | 164.5 132.4–204.4ROR 165.0 · calibrated p 3e-9 ✓ | 129.2 EB05 109.4 · IC025 +6.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.1) | Not in label — unassessed | serious n=101 · ♀ 100% (drug 38%) · 94% clinician | no trial arm names this drug |
| Vertical infection transmission | 21 | 155.2 96.6–249.5ROR 155.3 · calibrated p 2e-8 ✓ | 113.5 EB05 78.3 · IC025 +4.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.6 (1.4–4.9) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Kaposi's sarcoma | 94 | 154.6 123.6–193.4ROR 155.1 · calibrated p 5e-9 ✓ | 122.8 EB05 103.3 · IC025 +5.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 3.0 (2.2–4.0) | Not in label — unassessed | serious n=74 · ♀ 13% (drug 38%) · 91% clinician | no trial arm names this drug |
| Ergot poisoning | 21 | 135.8 85.0–217.1ROR 135.9 · calibrated p 5e-8 ✓ | 102.8 EB05 71.0 · IC025 +4.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.3–4.3) | Not in label — unassessed | serious n=21 | no trial arm names this drug |
| Immune reconstitution inflammatory syndrome | 762 | 122.7 113.6–132.4ROR 125.7 · calibrated p 2e-8 ✓ | 103.6 EB05 97.6 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.6 (2.3–2.9) | Labeled (related wording) related wording | serious n=699 · 96% clinician | no trial arm names this drug |
| Congenital umbilical hernia | 56 | 119.6 90.0–158.9ROR 119.8 · calibrated p 5e-8 ✓ | 98.4 EB05 78.6 · IC025 +5.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.7–3.5) | Not in label — unassessed | serious n=55 · 96% clinician | no trial arm names this drug |
| Fanconi syndrome acquired | 260 | 119.1 104.5–135.9ROR 120.1 · calibrated p 3e-8 ✓ | 100.6 EB05 90.8 · IC025 +6.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (1.9–2.6) | Not in label — unassessed | serious n=210 · 94% clinician | no trial arm names this drug |
| Cd4 lymphocytes increased | 34 | 114.9 79.9–165.3ROR 115.1 · calibrated p 1e-7 ✓ | 93.3 EB05 69.8 · IC025 +4.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.9 (1.8–4.8) | Lab value / disease marker | serious n=28 · 91% clinician | no trial arm names this drug |
| Mitochondrial cytopathy | 63 | 112.7 86.3–147.1ROR 112.9 · calibrated p 7e-8 ✓ | 94.0 EB05 76.1 · IC025 +5.4 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 4.3 (2.8–6.5) | Not in label — unassessed | serious n=35 | no trial arm names this drug |
| Dandy-walker syndrome | 34 | 102.6 71.5–147.1ROR 102.7 · calibrated p 2e-7 ✓ | 85.0 EB05 63.6 · IC025 +4.7 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.5–3.8) | Not in label — unassessed | serious n=34 · ♀ 0% (drug 38%) · 100% clinician | no trial arm names this drug |
| Hepatitis b reactivation | 400 | 98.3 88.6–109.1ROR 99.6 · calibrated p 1e-7 ✓ | 85.6 EB05 78.7 · IC025 +6.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.7 (1.5–1.9) | Labeled — boxed warning synonym match | serious n=394 · 99% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Lamivudine only as a background or rescue medication (NCT01061151, NCT00074581); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 2,020 | 17.4 16.7–18.1ROR 18.5 · calibrated p 0.003 ✓ | 17.0 EB05 16.4 · IC025 +4.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.5 (2.4–2.7) | Reporting / coding artifact | serious PRR 11.1 | no trial arm names this drug |
| Virologic failure | 1,957 | 390.7 370.0–412.7ROR 417.3 · calibrated p 4e-13 ✓ | 246.9 EB05 237.9 · IC025 +7.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (2.3–2.6) | Not in label — unassessed | serious n=1,892 · 98% clinician | no trial arm names this drug |
| Drug resistance | 1,956 | 56.2 53.8–58.8ROR 60.0 · calibrated p 4e-6 ✓ | 52.0 EB05 50.1 · IC025 +5.6 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (1.7–1.9) | Reporting / coding artifact | serious PRR 40.1 · 95% clinician | no trial arm names this drug |
| Drug interaction | 1,865 | 8.1 7.8–8.5ROR 8.6 · calibrated p 0.054 | 8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.3) | Reporting / coding artifact | serious PRR 6.1 · ♀ 17% (drug 38%) · 91% clinician | no trial arm names this drug |
| Pathogen resistance | 1,770 | 165.1 156.9–173.7ROR 175.1 · calibrated p 1e-9 ✓ | 132.5 EB05 127.4 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.4) | Reporting / coding artifact | serious PRR 99.2 · 98% clinician | no trial arm names this drug |
| Viral mutation identified | 1,670 | 563.4 528.4–600.6ROR 595.7 · calibrated p 9e-15 ✓ | 306.0 EB05 293.8 · IC025 +8.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.4) | Not in label — unassessed | serious n=1,650 · 98% clinician | no trial arm names this drug |
| Depression | 1,340 | 4.0 3.8–4.2ROR 4.2 · calibrated p 0.350 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.9 (2.6–3.1) | Labeled (related wording) related wording | serious PRR 3.2 · ♀ 6% (drug 38%) | no trial arm names this drug |
| Pyrexia (fever) | 1,276 | 2.5 2.4–2.7ROR 2.6 · calibrated p 0.777 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.9 (1.8–2.1) | Labeled (related wording) related wording | serious PRR 1.7 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,157 | 0.6 0.6–0.6ROR 0.6 · calibrated p 0.078 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (1.7–2.0) | Reporting / coding artifact | serious PRR 1.1 | no trial arm names this drug |
| Anaemia (low red blood cells) | 1,122 | 4.0 3.8–4.3ROR 4.1 · calibrated p 0.352 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.1–2.4) | Labeled adverse reaction exact term | serious PRR 2.3 | no trial arm names this drug |
| Pain | 1,117 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.473 | 1.2 EB05 1.2 · IC025 +0.2 vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 4.5 (4.0–4.9) | Labeled adverse reaction exact term | serious PRR 0.5 | no trial arm names this drug |
| Nausea | 1,072 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.259 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.1 (2.0–2.3) | Labeled adverse reaction exact term | serious PRR 1.0 · ♀ 63% (drug 38%) | no trial arm names this drug |
| Treatment failure | 1,020 | 8.6 8.1–9.1ROR 8.8 · calibrated p 0.049 ✓ | 8.5 EB05 8.0 · IC025 +3.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.0–2.3) | Reporting / coding artifact | serious PRR 11.5 · 98% clinician | no trial arm names this drug |
| Vomiting | 1,017 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.641 | 1.5 EB05 1.4 · IC025 +0.5 vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (2.2–2.6) | Labeled adverse reaction exact term | serious PRR 1.3 · ♀ 59% (drug 38%) | no trial arm names this drug |
| Anxiety | 987 | 2.4 2.2–2.5ROR 2.4 · calibrated p 0.852 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 5.5 (4.9–6.2) | Not in label — unassessed | serious PRR 0.9 | no trial arm names this drug |
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.
- Pinealoblastoma — n=75, PRR 2,802.7
- Progressive external ophthalmoplegia — n=101, PRR 2,426.4
- Congenital neoplasm — n=21, PRR 2,354.3
- Csf hiv escape syndrome — n=83, PRR 1,015.1
- Hiv viraemia — n=115, PRR 850.1
- Ultrasound antenatal screen — n=50, PRR 764.4
- Viral mutation identified — n=1,670, PRR 563.4
- Aids encephalopathy — n=25, PRR 509.6
- Genetic polymorphism — n=24, PRR 489.2
- Hiv associated nephropathy — n=20, PRR 448.4
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?
In FDA FAERS, the most frequently co-reported reaction terms for Lamivudine are virologic failure, viral mutation identified, depression, pyrexia, anaemia, pain. 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 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 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, fieldpatient.drug.openfda.generic_name.exact, 1,194 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 - ClinicalTrials.gov API v2 (query
LAMIVUDINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.