Drug · FAERS side-effect profile with label screen
Lamotrigine side effects: what 130,963 FDA adverse event reports show
Drug class
Anti-epileptic Agent, Mood Stabilizer
FDA label (Established Pharmacologic Class) · compare the class
Who reports
130,963 reports · 72% serious · 11,279 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lamotrigine is indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: · partial-onset seizures. · primary generalized tonic-clonic (PGTC) seizures. · generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy - monother.
FDA label, Indications and Usage
What it is
Lamotrigine is a member of the class of 1,2,4-triazines in which the triazene skeleton is substituted by amino groups at positions 3 and 5, and by a 2,3-dichlorophenyl group at position 6.
PubChem CID 3878 (ChEBI)
Boxed warning
SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine.
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 2Labeled adverse reaction 1Labeled (related wording) 7Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 19
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, 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). 1,217 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 |
|---|---|---|---|---|---|---|
| Sudden unexplained death in epilepsy | 170 | 73.3 61.1–87.9ROR 73.4 · calibrated p 1e-6 ✓ | 50.0 EB05 44.0 · IC025 +5.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.9 (4.9–7.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=170 · 100% clinician | not reported in cached trials |
| Lip erosion | 225 | 70.4 60.1–82.3ROR 70.5 · calibrated p 2e-6 ✓ | 48.7 EB05 43.6 · IC025 +5.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 30.8 (24.5–38.7) | Not in label — unassessed | serious n=225 | not reported in cached trials |
| Hypocholesterolaemia | 88 | 64.0 49.9–81.9ROR 64.0 · calibrated p 4e-6 ✓ | 45.3 EB05 37.9 · IC025 +4.8 3/3 methods agree vs other Anti-epileptic Agents: only this drug | Not in label — unassessed | serious n=88 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 744 | 49.3 45.4–53.5ROR 49.6 · calibrated p 1e-5 ✓ | 37.7 EB05 35.5 · IC025 +5.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 21.8 (19.5–24.4) | Not in label — unassessed | serious n=744 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Oral mucosa erosion | 244 | 39.6 34.4–45.6ROR 39.7 · calibrated p 6e-5 ✓ | 31.8 EB05 28.6 · IC025 +4.7 3/3 methods agree vs other Anti-epileptic Agents: PRR 26.6 (21.6–32.8) | Not in label — unassessed | serious n=243 | not reported in cached trials |
| Anticonvulsant drug level above therapeutic | 126 | 38.2 31.4–46.4ROR 38.2 · calibrated p 8e-5 ✓ | 30.8 EB05 26.5 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.4 (3.6–5.3) | Lab value / disease marker | serious n=114 | not reported in cached trials |
| Overlap syndrome | 122 | 34.3 28.2–41.7ROR 34.3 · calibrated p 1e-4 ✓ | 28.2 EB05 24.2 · IC025 +4.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 8.4 (6.7–10.4) | Not in label — unassessed | serious n=122 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Multiple-drug resistance | 543 | 33.9 30.9–37.2ROR 34.1 · calibrated p 1e-4 ✓ | 28.1 EB05 26.1 · IC025 +4.6 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.0 (2.7–3.3) | Reporting / coding artifact | serious n=441 · 91% clinician | not reported in cached trials |
| Partial seizures with secondary generalisation | 81 | 33.3 26.2–42.3ROR 33.3 · calibrated p 2e-4 ✓ | 27.5 EB05 22.8 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.9 (3.0–4.9) | Labeled (related wording) related wording | serious n=80 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 638 | 30.3 27.9–33.0ROR 30.5 · calibrated p 2e-4 ✓ | 25.6 EB05 23.9 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 18.7 (16.7–21.0) | Labeled (related wording) related wording | serious n=636 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Focal dyscognitive seizures | 181 | 30.0 25.6–35.2ROR 30.0 · calibrated p 3e-4 ✓ | 25.3 EB05 22.3 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.7 (3.2–4.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=178 | not reported in cached trials |
| Onychomadesis | 647 | 29.4 27.0–32.0ROR 29.5 · calibrated p 3e-4 ✓ | 24.9 EB05 23.3 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 23.3 (20.6–26.4) | Not in label — unassessed | serious n=643 · ♀ 100% (drug 68%) · 94% clinician | not reported in cached trials |
| Complex partial seizures | 173 | 28.9 24.6–34.0ROR 28.9 · calibrated p 3e-4 ✓ | 24.5 EB05 21.6 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.4 (6.2–8.9) | Labeled (related wording) related wording | serious n=169 | not reported in cached trials |
| Blepharospasm | 936 | 28.3 26.4–30.3ROR 28.5 · calibrated p 3e-4 ✓ | 24.1 EB05 22.9 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 18.0 (16.4–19.8) | Not in label — unassessed | serious n=905 · ♀ 97% (drug 68%) | not reported in cached trials |
| Aura | 280 | 28.2 24.9–32.1ROR 28.3 · calibrated p 4e-4 ✓ | 24.1 EB05 21.8 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 11.1 (9.5–13.0) | Not in label — unassessed | serious n=219 | not reported in cached trials |
| Atonic seizures | 114 | 26.6 21.8–32.4ROR 26.6 · calibrated p 6e-4 ✓ | 22.8 EB05 19.5 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.3 (3.5–5.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=106 | not reported in cached trials |
| Myoclonic epilepsy | 210 | 26.5 22.9–30.7ROR 26.5 · calibrated p 5e-4 ✓ | 22.8 EB05 20.3 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.3 (3.7–5.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=207 | not reported in cached trials |
| Enanthema | 81 | 26.0 20.6–32.9ROR 26.0 · calibrated p 6e-4 ✓ | 22.3 EB05 18.6 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: only this drug | Not in label — unassessed | serious n=81 | not reported in cached trials |
| Petit mal epilepsy | 696 | 25.3 23.3–27.4ROR 25.4 · calibrated p 6e-4 ✓ | 21.9 EB05 20.6 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.3 (5.8–6.9) | Labeled (related wording) related wording | serious n=674 | not reported in cached trials |
| Anticonvulsant drug level decreased | 193 | 24.9 21.4–29.0ROR 24.9 · calibrated p 7e-4 ✓ | 21.6 EB05 19.2 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.6 (3.9–5.4) | Lab value / disease marker | serious n=165 | not reported in cached trials |
| Selective eating disorder | 122 | 24.6 20.4–29.8ROR 24.7 · calibrated p 8e-4 ✓ | 21.4 EB05 18.4 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 8.6 (6.9–10.7) | Not in label — unassessed | serious n=122 | not reported in cached trials |
| Sjs-ten overlap | 85 | 24.0 19.1–30.2ROR 24.1 · calibrated p 9e-4 ✓ | 20.9 EB05 17.4 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.8 (6.0–10.1) | Not in label — unassessed | serious n=85 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Change in seizure presentation | 86 | 24.0 19.1–30.1ROR 24.0 · calibrated p 9e-4 ✓ | 20.9 EB05 17.4 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.7 (3.7–6.0) | Labeled (related wording) related wording | serious n=80 · ♀ 0% (drug 68%) | not reported in cached trials |
| Breast cancer stage iii | 810 | 22.9 21.3–24.7ROR 23.1 · calibrated p 0.001 ✓ | 20.1 EB05 19.0 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 22.7 (20.4–25.3) | Not in label — unassessed | serious n=810 · ♀ 100% (drug 68%) · 95% clinician | not reported in cached trials |
| Developmental hip dysplasia | 100 | 21.7 17.6–26.8ROR 21.7 · calibrated p 0.001 ✓ | 19.1 EB05 16.2 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.9 (4.7–7.5) | Not in label — unassessed | serious n=100 · 100% clinician | not reported in cached trials |
| Stevens-johnson syndrome (severe blistering skin reaction) | 2,615 | 21.2 20.3–22.1ROR 21.6 · calibrated p 0.001 ✓ | 18.8 EB05 18.2 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 9.9 (9.4–10.3) | Labeled — boxed warning exact term | age-adj. PRR 18.6 · serious PRR 15.0 | not reported in cached trials |
| Rheumatic fever | 509 | 21.0 19.2–23.0ROR 21.1 · calibrated p 0.002 ✓ | 18.6 EB05 17.3 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 19.7 (17.2–22.4) | Not in label — unassessed | serious n=509 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Seizure cluster | 92 | 20.6 16.6–25.6ROR 20.6 · calibrated p 0.002 ✓ | 18.2 EB05 15.3 · IC025 +3.7 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.0 (3.2–5.1) | Labeled adverse reaction exact term | serious n=86 · ♀ 0% (drug 68%) · 100% consumer | not reported in cached trials |
| Anticonvulsant drug level increased | 184 | 20.3 17.4–23.7ROR 20.3 · calibrated p 0.002 ✓ | 18.1 EB05 16.0 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.5 (3.0–4.1) | Lab value / disease marker | serious n=176 | not reported in cached trials |
| Anticonvulsant drug level below therapeutic | 86 | 20.3 16.2–25.4ROR 20.3 · calibrated p 0.002 ✓ | 18.0 EB05 15.0 · IC025 +3.7 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.9 (3.9–6.3) | Lab value / disease marker | serious n=75 · ♀ 0% (drug 68%) | not reported in cached trials |
| Duodenal ulcer perforation | 824 | 20.1 18.7–21.7ROR 20.3 · calibrated p 0.002 ✓ | 18.0 EB05 17.0 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 23.3 (20.9–25.9) | Labeled (related wording) related wording | serious PRR 14.4 · ♀ 100% (drug 68%) · 95% clinician | not reported in cached trials |
| Epilepsy | 3,415 | 20.1 19.4–20.8ROR 20.6 · calibrated p 0.002 ✓ | 17.9 EB05 17.4 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.3 (7.1–7.6) | Labeled — boxed warning exact term | age-adj. PRR 16.3 · serious PRR 14.3 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 792 | 20.0 18.6–21.5ROR 20.1 · calibrated p 0.002 ✓ | 17.8 EB05 16.8 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 24.9 (22.2–27.8) | Lab value / disease marker | serious PRR 14.3 · ♀ 100% (drug 68%) · 95% clinician | not reported in cached trials |
| Live birth | 905 | 19.4 18.1–20.8ROR 19.6 · calibrated p 0.002 ✓ | 17.4 EB05 16.5 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 22.7 (20.5–25.1) | Not in label — unassessed | serious PRR 15.1 · ♀ 100% (drug 68%) | not reported in cached trials |
| Partial seizures | 548 | 18.9 17.3–20.7ROR 19.0 · calibrated p 0.003 ✓ | 17.0 EB05 15.8 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.0 (4.6–5.5) | Likely indication confounding term in indications; also in warnings | serious n=529 | not reported in cached trials |
| Hypospadias | 219 | 18.9 16.4–21.8ROR 18.9 · calibrated p 0.003 ✓ | 17.0 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.2 (5.3–7.3) | Not in label — unassessed | serious n=219 · ♀ 0% (drug 68%) · 100% clinician | NCT01064297: 1/497 (0.2%) on Lamotrigine (serious AE) |
| Onychomycosis | 456 | 18.5 16.8–20.4ROR 18.6 · calibrated p 0.003 ✓ | 16.7 EB05 15.4 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 68.7 (55.4–85.3) | Not in label — unassessed | serious n=449 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Pleurothotonus | 94 | 18.3 14.8–22.7ROR 18.3 · calibrated p 0.003 ✓ | 16.4 EB05 13.8 · IC025 +3.6 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.6 (5.2–8.4) | Not in label — unassessed | serious n=92 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Agitation neonatal | 97 | 18.0 14.6–22.3ROR 18.1 · calibrated p 0.003 ✓ | 16.2 EB05 13.7 · IC025 +3.6 3/3 methods agree vs other Anti-epileptic Agents: PRR 9.1 (7.1–11.8) | Not in label — unassessed | serious n=97 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Simple partial seizures | 82 | 17.8 14.1–22.3ROR 17.8 · calibrated p 0.004 ✓ | 16.0 EB05 13.3 · IC025 +3.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.3 (3.4–5.5) | Labeled (related wording) related wording | serious n=79 | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Severe cutaneous reaction | 6,166 | 14.414.0–14.8 | signal |
| Seizure | 12,350 | 10.710.5–10.9 | signal |
| Suicidality | 8,738 | 5.95.7–6.0 | signal |
| Extrapyramidal | 2,543 | 3.93.8–4.1 | signal |
| Depression | 6,088 | 3.53.4–3.6 | signal |
| Liver injury | 4,081 | 2.22.1–2.2 | signal |
| Hyponatraemia | 1,064 | 2.12.0–2.3 | signal |
| Rhabdomyolysis / myopathy | 1,054 | 2.12.0–2.2 | raised |
| Fall / fracture | 3,872 | 1.61.6–1.7 | raised |
| Pancreatitis | 655 | 1.31.2–1.4 | raised |
| Arrhythmia / qt | 1,379 | 1.11.1–1.2 | raised |
| Hyperglycaemia / diabetes | 2,454 | 1.11.1–1.2 | raised |
| Thrombocytopenia | 1,265 | 0.90.9–1.0 | lower than other drugs |
| Serious infection | 4,270 | 0.90.9–0.9 | lower than other drugs |
| Dependence / withdrawal | 1,607 | 0.90.8–0.9 | lower than other drugs |
| Kidney injury | 2,178 | 0.80.7–0.8 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lamotrigine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01064297 — Lamotrigine Pregnancy Registry (LAM05) (N=3416, phase n/a; 32 AE terms posted; arms: Lamotrigine Monotherapy Pregnancy Exposu; Lamotrigine Polytherapy With Valproate P; Lamotrigine Polytherapy Without Valproat)
- NCT00277212 — A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term M (N=1169, PHASE4; 52 AE terms posted; arms: Phase 1: Single-Blind Treatment, Lamotri; Phase 2 Double-Blind Treatment: Lamotrig; Phase 2 Double-Blind Treatment: Lamotrig)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 ineffective (drug did not work) | 10,264 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.488 | 1.2 EB05 1.2 · IC025 +0.3 vs other Anti-epileptic Agents: PRR 5.8 (5.7–6.0) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.9 | not reported in cached trials |
| Rash | 8,633 | 3.2 3.2–3.3ROR 3.4 · calibrated p 0.512 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Anti-epileptic Agents: PRR 15.4 (15.0–15.8) | Labeled — boxed warning exact term | age-adj. PRR 3.0 · serious PRR 3.5 | not reported in cached trials |
| Seizure | 6,797 | 10.0 9.8–10.3ROR 10.5 · calibrated p 0.027 ✓ | 9.5 EB05 9.3 · IC025 +3.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.0 (4.9–5.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 6.9 · serious PRR 7.4 | not reported in cached trials |
| Nausea | 6,401 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.519 | 1.3 EB05 1.3 · IC025 +0.3 vs other Anti-epileptic Agents: PRR 10.1 (9.8–10.4) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.4 | NCT00277212: 7/176 (4.0%) on Lamotrigine; 6/165 (3.6%) control |
| Off label use (used outside approved label) | 6,174 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.404 | 1.1 EB05 1.1 · IC025 +0.1 vs other Anti-epileptic Agents: PRR 6.7 (6.5–6.9) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Fatigue (tiredness) | 6,174 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.500 | 1.3 EB05 1.2 · IC025 +0.3 vs other Anti-epileptic Agents: PRR 9.0 (8.7–9.2) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.3 | NCT00277212: 5/176 (2.8%) on Lamotrigine; 1/165 (0.6%) control |
| Dizziness | 6,034 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.943 | 1.9 EB05 1.9 · IC025 +0.9 vs other Anti-epileptic Agents: PRR 9.2 (9.0–9.5) | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.0 | NCT00277212: 1/165 (0.6%) control (serious AE) |
| Headache | 5,771 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.643 | 1.5 EB05 1.4 · IC025 +0.5 vs other Anti-epileptic Agents: PRR 9.9 (9.6–10.3) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.7 | NCT00277212: 8/176 (4.5%) on Lamotrigine; 13/165 (7.9%) control |
| Depression | 5,191 | 3.7 3.6–3.8ROR 3.8 · calibrated p 0.415 | 3.6 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 10.0 (9.7–10.3) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 3.2 · serious PRR 3.2 | NCT00277212: 1/176 (0.6%) on Lamotrigine (serious AE) |
| Vomiting | 4,791 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.749 | 1.6 EB05 1.6 · IC025 +0.7 vs other Anti-epileptic Agents: PRR 8.8 (8.5–9.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00277212: 1/176 (0.6%) on Lamotrigine; 1/165 (0.6%) control |
| Somnolence (drowsiness) | 4,505 | 3.6 3.5–3.8ROR 3.7 · calibrated p 0.429 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.5 (6.3–6.7) | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 3.6 | NCT00277212: 1/176 (0.6%) on Lamotrigine |
| Drug interaction | 4,470 | 4.6 4.5–4.7ROR 4.7 · calibrated p 0.264 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.8 (4.6–4.9) | Reporting / coding artifact | age-adj. PRR 4.2 · serious PRR 3.6 | not reported in cached trials |
| Pyrexia (fever) | 4,467 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.993 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 9.4 (9.0–9.7) | Labeled (related wording) related wording | age-adj. PRR 1.8 · serious PRR 1.9 | not reported in cached trials |
| Anxiety | 4,461 | 2.5 2.5–2.6ROR 2.6 · calibrated p 0.779 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 10.1 (9.8–10.5) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.2 | NCT00277212: 1/787 (0.1%) on Lamotrigine (serious AE) |
| Toxicity to various agents | 4,247 | 4.1 4.0–4.3ROR 4.2 · calibrated p 0.336 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.1 (4.9–5.3) | Labeled (related wording) related wording | age-adj. PRR 3.7 · serious PRR 3.2 · 94% clinician | not reported in cached trials |
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.
- Lip erosion — n=225, PRR 70.4
- Hypocholesterolaemia — n=88, PRR 64.0
- Facet joint syndrome — n=744, PRR 49.3
- Oral mucosa erosion — n=244, PRR 39.6
- Overlap syndrome — n=122, PRR 34.3
- Onychomadesis — n=647, PRR 29.4
- Blepharospasm — n=936, PRR 28.3
- Aura — n=280, PRR 28.2
- Enanthema — n=81, PRR 26.0
- Selective eating disorder — n=122, PRR 24.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Lamotrigine ↔ Stevens–Johnson syndrome / toxic epidermal necrolysis.
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 Lamotrigine?
In FDA FAERS, the most frequently co-reported reaction terms for Lamotrigine are rash, seizure, nausea, fatigue, dizziness, headache. 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 Lamotrigine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine.
Do FAERS signals prove that Lamotrigine 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 05cba628-b12c-44d8-89a8-3522fe417cc1, effective 20260226; matched on
openfda.generic_name.exact:"LAMOTRIGINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3878 description (ChEBI)
- 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, 1,257 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
LAMOTRIGINE, 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.