Drug · FAERS side-effect profile with label screen
Lamivudine Oral 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). 1,109 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 | 74 | 3,200.5 1,933.6–5,297.5ROR 3,209.9 · calibrated p 2e-21 ✓ | 559.4 EB05 460.4 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (1.7–3.2) | Not in label — unassessed | serious n=74 · ♀ 0% (drug 38%) | no trial arm names this drug |
| Progressive external ophthalmoplegia | 101 | 2,964.1 1,950.6–4,504.2ROR 2,976.1 · calibrated p 1e-21 ✓ | 573.7 EB05 485.8 · 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=101 · ♀ 0% (drug 38%) · 93% clinician | no trial arm names this drug |
| Csf hiv virus identified | 18 | 2,958.3 1,098.4–7,967.4ROR 2,960.4 · calibrated p 3e-16 ✓ | 381.9 EB05 255.6 · 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 | 2,876.1 1,160.9–7,125.3ROR 2,878.5 · calibrated p 6e-17 ✓ | 403.8 EB05 278.6 · 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 | 33 | 1,694.8 933.0–3,078.8ROR 1,697.1 · calibrated p 2e-17 ✓ | 419.0 EB05 312.2 · IC025 +5.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.2 (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 | 1,240.1 882.2–1,743.2ROR 1,244.2 · calibrated p 1e-17 ✓ | 444.0 EB05 369.4 · IC025 +6.6 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 | 1,038.5 789.0–1,366.8ROR 1,043.2 · calibrated p 5e-17 ✓ | 426.6 EB05 365.0 · IC025 +7.0 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=115 · 100% clinician | no trial arm names this drug |
| Ultrasound antenatal screen | 49 | 894.8 597.1–1,340.9ROR 896.5 · calibrated p 1e-15 ✓ | 367.2 EB05 288.8 · IC025 +5.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (1.6–3.5) | Not in label — unassessed | serious n=49 · 100% clinician | no trial arm names this drug |
| Human immunodeficiency virus transmission | 118 | 697.6 546.0–891.3ROR 700.9 · calibrated p 4e-15 ✓ | 355.9 EB05 305.2 · IC025 +6.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.4 (1.8–3.0) | 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 | 1,652 | 674.7 632.9–719.2ROR 722.1 · calibrated p 1e-15 ✓ | 369.4 EB05 354.7 · IC025 +8.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.0–2.3) | Not in label — unassessed | serious n=1,650 · 98% clinician | no trial arm names this drug |
| Genetic polymorphism | 24 | 597.6 353.3–1,010.9ROR 598.2 · calibrated p 3e-13 ✓ | 271.5 EB05 192.0 · 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 |
| Immune reconstitution syndrome | 502 | 522.8 467.8–584.3ROR 533.5 · calibrated p 3e-14 ✓ | 316.1 EB05 293.5 · IC025 +7.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.9 (1.7–2.1) | Labeled — boxed warning exact term | serious n=499 | no trial arm names this drug |
| Total lung capacity increased | 101 | 491.1 383.9–628.2ROR 493.1 · calibrated p 1e-13 ✓ | 290.8 EB05 246.2 · IC025 +6.6 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 | 1,899 | 455.3 431.1–480.9ROR 492.5 · calibrated p 7e-14 ✓ | 292.5 EB05 281.6 · IC025 +8.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (2.1–2.4) | Not in label — unassessed | serious n=1,892 · 98% clinician | no trial arm names this drug |
| Hiv associated nephropathy | 17 | 423.3 235.8–759.9ROR 423.6 · calibrated p 2e-11 ✓ | 213.0 EB05 140.9 · IC025 +4.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.6 (0.8–2.9) | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Aids encephalopathy | 19 | 400.3 231.4–692.6ROR 400.6 · calibrated p 2e-11 ✓ | 212.2 EB05 143.6 · IC025 +4.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (1.0–3.3) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Hiv-associated neurocognitive disorder | 33 | 347.7 231.5–522.2ROR 348.1 · calibrated p 1e-11 ✓ | 214.4 EB05 159.7 · 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 |
| Granulomatous rosacea | 14 | 328.7 176.9–610.8ROR 328.9 · calibrated p 2e-10 ✓ | 178.3 EB05 112.9 · IC025 +3.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: only this drug | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Aids related complication | 18 | 314.7 182.8–541.7ROR 314.9 · calibrated p 1e-10 ✓ | 183.7 EB05 123.0 · IC025 +4.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.9 (1.0–3.6) | Reporting / coding artifact | serious n=18 | no trial arm names this drug |
| Mitochondrial toxicity | 217 | 299.7 256.7–349.9ROR 302.3 · calibrated p 1e-11 ✓ | 215.7 EB05 192.7 · IC025 +7.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (1.8–2.6) | Not in label — unassessed | serious n=216 · ♀ 17% (drug 38%) | no trial arm names this drug |
| Birth mark | 53 | 281.0 205.7–383.7ROR 281.6 · calibrated p 5e-11 ✓ | 195.0 EB05 154.8 · IC025 +5.7 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 | 22 | 258.3 160.0–416.9ROR 258.5 · calibrated p 4e-10 ✓ | 168.3 EB05 117.1 · IC025 +4.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (1.3–4.1) | Not in label — unassessed | serious n=22 | no trial arm names this drug |
| Congenital teratoma | 20 | 252.8 153.2–417.3ROR 253.0 · calibrated p 5e-10 ✓ | 163.6 EB05 111.8 · 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 |
| Lipodystrophy acquired | 476 | 240.0 216.8–265.6ROR 244.6 · calibrated p 7e-11 ✓ | 184.6 EB05 171.1 · IC025 +7.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.0 (1.8–2.3) | Not in label — unassessed | serious n=474 | no trial arm names this drug |
| Blood hiv rna increased | 392 | 233.8 209.1–261.3ROR 237.4 · calibrated p 9e-11 ✓ | 180.6 EB05 166.1 · IC025 +7.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (1.9–2.5) | Lab value / disease marker | serious n=390 · 98% clinician | no trial arm names this drug |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 70 | 222.1 170.6–289.1ROR 222.7 · calibrated p 3e-10 ✓ | 167.1 EB05 136.8 · IC025 +5.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (1.6–3.2) | Labeled (related wording) related wording | serious n=70 · 100% clinician | no trial arm names this drug |
| Hepatitis b dna increased | 139 | 216.7 179.9–261.2ROR 217.9 · calibrated p 3e-10 ✓ | 167.8 EB05 145.7 · IC025 +6.5 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.1 (0.9–1.4) | Lab value / disease marker | serious n=139 · 91% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 101 | 201.0 161.7–249.7ROR 201.8 · calibrated p 6e-10 ✓ | 156.9 EB05 132.9 · IC025 +6.2 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 |
| Pathogen resistance | 1,736 | 196.8 187.1–207.1ROR 211.4 · calibrated p 2e-10 ✓ | 158.7 EB05 152.6 · IC025 +7.2 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 99.2 · 98% clinician | no trial arm names this drug |
| Hepatitis b virus | 15 | 186.8 106.6–327.1ROR 186.9 · calibrated p 1e-8 ✓ | 127.9 EB05 82.3 · IC025 +3.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (0.9–3.5) | Labeled — boxed warning exact term | serious n=15 | no trial arm names this drug |
| Retinoblastoma | 19 | 175.4 106.9–287.8ROR 175.6 · calibrated p 9e-9 ✓ | 126.6 EB05 85.7 · IC025 +4.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (1.0–3.3) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Vertical infection transmission | 19 | 167.9 102.5–274.9ROR 168.0 · calibrated p 1e-8 ✓ | 122.7 EB05 83.0 · IC025 +4.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.1 (1.2–4.0) | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Ergot poisoning | 21 | 165.9 103.8–265.1ROR 166.1 · calibrated p 1e-8 ✓ | 123.0 EB05 84.9 · IC025 +4.3 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 |
| Kaposi's sarcoma | 75 | 144.0 112.7–184.0ROR 144.4 · calibrated p 1e-8 ✓ | 119.0 EB05 98.1 · IC025 +5.7 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.9 (1.4–2.6) | Not in label — unassessed | serious n=74 · ♀ 13% (drug 38%) · 91% clinician | no trial arm names this drug |
| Congenital umbilical hernia | 55 | 143.0 107.4–190.4ROR 143.3 · calibrated p 1e-8 ✓ | 117.1 EB05 93.4 · IC025 +5.4 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (1.6–3.4) | Not in label — unassessed | serious n=55 · 96% clinician | no trial arm names this drug |
| Urine phosphorus increased | 16 | 142.9 84.1–243.0ROR 143.0 · calibrated p 5e-8 ✓ | 106.7 EB05 69.6 · IC025 +3.9 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: only this drug | Lab value / disease marker | serious n=16 | no trial arm names this drug |
| Immune reconstitution inflammatory syndrome | 700 | 135.6 125.3–146.8ROR 139.5 · calibrated p 9e-9 ✓ | 116.2 EB05 109.1 · IC025 +6.6 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.0–2.4) | Labeled (related wording) related wording | serious n=699 · 96% clinician | no trial arm names this drug |
| Dandy-walker syndrome | 34 | 125.3 87.4–179.7ROR 125.5 · calibrated p 5e-8 ✓ | 102.7 EB05 76.9 · IC025 +4.8 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 | 394 | 118.0 106.3–131.1ROR 119.9 · calibrated p 3e-8 ✓ | 102.8 EB05 94.6 · IC025 +6.3 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 |
| Fanconi syndrome acquired | 210 | 113.7 98.5–131.3ROR 114.6 · calibrated p 5e-8 ✓ | 99.1 EB05 88.4 · IC025 +6.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.5 (1.3–1.8) | Not in label — unassessed | serious n=210 · 94% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Lamivudine Oral 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 |
|---|---|---|---|---|---|---|
| Virologic failure | 1,899 | 455.3 431.1–480.9ROR 492.5 · calibrated p 7e-14 ✓ | 292.5 EB05 281.6 · IC025 +8.0 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.3 (2.1–2.4) | Not in label — unassessed | serious n=1,892 · 98% clinician | no trial arm names this drug |
| Drug resistance | 1,880 | 65.8 62.9–68.9ROR 71.1 · calibrated p 1e-6 ✓ | 61.0 EB05 58.7 · IC025 +5.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.6 (1.6–1.7) | Reporting / coding artifact | serious PRR 40.1 · 95% clinician | no trial arm names this drug |
| Foetal exposure during pregnancy | 1,794 | 18.8 18.0–19.7ROR 20.2 · calibrated p 0.002 ✓ | 18.4 EB05 17.7 · IC025 +4.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.0 (1.9–2.1) | Reporting / coding artifact | serious PRR 11.1 | no trial arm names this drug |
| Drug interaction | 1,773 | 9.4 9.0–9.8ROR 10.0 · calibrated p 0.032 ✓ | 9.3 EB05 8.9 · IC025 +3.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.0 (1.9–2.1) | Reporting / coding artifact | serious PRR 6.1 · ♀ 17% (drug 38%) · 91% clinician | no trial arm names this drug |
| Pathogen resistance | 1,736 | 196.8 187.1–207.1ROR 211.4 · calibrated p 2e-10 ✓ | 158.7 EB05 152.6 · IC025 +7.2 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 99.2 · 98% clinician | no trial arm names this drug |
| Viral mutation identified | 1,652 | 674.7 632.9–719.2ROR 722.1 · calibrated p 1e-15 ✓ | 369.4 EB05 354.7 · IC025 +8.3 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.0–2.3) | Not in label — unassessed | serious n=1,650 · 98% clinician | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,063 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.110 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.6 (1.5–1.7) | Reporting / coding artifact | serious PRR 1.1 | no trial arm names this drug |
| Depression | 1,059 | 3.9 3.7–4.1ROR 4.0 · calibrated p 0.377 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.8 (1.7–1.9) | Labeled (related wording) related wording | serious PRR 3.2 · ♀ 6% (drug 38%) | no trial arm names this drug |
| Treatment failure | 1,011 | 10.4 9.8–11.0ROR 10.8 · calibrated p 0.025 ✓ | 10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.1 (2.0–2.3) | Reporting / coding artifact | serious PRR 11.5 · 98% clinician | no trial arm names this drug |
| Pyrexia (fever) | 959 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.873 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.2 (1.1–1.3) | Labeled (related wording) related wording | serious PRR 1.7 | no trial arm names this drug |
| Nausea | 866 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.251 | 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 1.5 (1.4–1.6) | Labeled adverse reaction exact term | serious PRR 1.0 · ♀ 63% (drug 38%) | no trial arm names this drug |
| Vomiting | 846 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.657 | 1.5 EB05 1.4 · IC025 +0.5 vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.7 (1.6–1.9) | Labeled adverse reaction exact term | serious PRR 1.3 · ♀ 59% (drug 38%) | no trial arm names this drug |
| Exposure during pregnancy | 837 | 11.4 10.6–12.2ROR 11.7 · calibrated p 0.018 ✓ | 11.2 EB05 10.6 · IC025 +3.4 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 2.2 (2.0–2.4) | Reporting / coding artifact | serious PRR 9.0 · ♀ 97% (drug 38%) · 90% clinician | no trial arm names this drug |
| Anaemia (low red blood cells) | 800 | 3.5 3.3–3.8ROR 3.6 · calibrated p 0.464 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.3 (1.2–1.4) | Labeled adverse reaction exact term | serious PRR 2.3 | no trial arm names this drug |
| Off label use (used outside approved label) | 730 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.127 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors: PRR 1.0 (0.9–1.1) | Reporting / coding artifact | serious PRR 0.8 · 91% clinician | 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=74, PRR 3,200.5
- Progressive external ophthalmoplegia — n=101, PRR 2,964.1
- Congenital neoplasm — n=21, PRR 2,876.1
- Csf hiv escape syndrome — n=83, PRR 1,240.1
- Hiv viraemia — n=115, PRR 1,038.5
- Ultrasound antenatal screen — n=49, PRR 894.8
- Viral mutation identified — n=1,652, PRR 674.7
- Genetic polymorphism — n=24, PRR 597.6
- Total lung capacity increased — n=101, PRR 491.1
- Virologic failure — n=1,899, PRR 455.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
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 Oral?
In FDA FAERS, the most frequently co-reported reaction terms for Lamivudine Oral are virologic failure, viral mutation identified, depression, pyrexia, nausea, vomiting. 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 Oral 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 Oral 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, 1,149 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.