Lamotrigine Chewable Dispersible side effects: what 71,201 FDA adverse event reports show
Drug class
Anti-epileptic Agent, Mood Stabilizer
Brand names
Lamotrigine
Who reports
71,201 reports · 81% serious · 8,154 with death outcome · 66% female
Used for
1. INDICATIONS AND USAGE Lamotrigine tablet for oral suspension USP (chewable dispersible tablet) is indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: · partial-onset seizures. · primary generalized tonic-clonic seizures. · generalized seizures of Lennox-Gastaut syndrome.
What it is
11. DESCRIPTION Lamotrigine tablets for oral suspension USP (chewable dispersible tablets), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical.
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.
Causality screen of the 40 strongest signals
What the badges mean
- 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). 1,246 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| New onset refractory status epilepticus | 45 | 217.2 147.5–319.6ROR 217.3 · calibrated p 8e-10 ✓ | 118.4 EB05 92.1 · IC025 +5.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.3 (4.5–9.0) | Labeled (related wording) related wording | serious n=45 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Postictal psychosis | 46 | 124.5 88.1–175.8ROR 124.6 · calibrated p 5e-8 ✓ | 84.4 EB05 65.8 · IC025 +5.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.9 (5.5–11.2) | Not in label — unassessed | serious n=46 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Sudden unexplained death in epilepsy | 128 | 91.3 74.8–111.3ROR 91.4 · calibrated p 3e-7 ✓ | 69.0 EB05 59.5 · IC025 +5.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.1 (3.3–4.9) | Labeled adverse reaction exact term | serious n=128 · 100% clinician | not reported in cached trials |
| Multiple-drug resistance | 517 | 59.0 53.7–64.8ROR 59.4 · calibrated p 5e-6 ✓ | 49.1 EB05 45.6 · IC025 +5.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.8 (2.6–3.1) | Reporting / coding artifact | serious n=423 · 94% clinician | not reported in cached trials |
| Overlap syndrome | 110 | 55.8 45.5–68.4ROR 55.9 · calibrated p 8e-6 ✓ | 46.6 EB05 39.7 · IC025 +5.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.1 (5.7–9.0) | Not in label — unassessed | serious n=110 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Partial seizures with secondary generalisation | 64 | 46.4 35.7–60.5ROR 46.5 · calibrated p 3e-5 ✓ | 39.7 EB05 32.2 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.9 (2.2–3.8) | Labeled (related wording) related wording | serious n=64 · 100% clinician | not reported in cached trials |
| Anticonvulsant drug level above therapeutic | 80 | 41.1 32.5–51.9ROR 41.1 · calibrated p 6e-5 ✓ | 35.8 EB05 29.7 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.5 (2.0–3.2) | Lab value / disease marker | serious n=78 | not reported in cached trials |
| Developmental hip dysplasia | 97 | 38.7 31.3–47.8ROR 38.7 · calibrated p 7e-5 ✓ | 34.0 EB05 28.7 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.7 (4.5–7.2) | Not in label — unassessed | serious n=97 | not reported in cached trials |
| Sjs-ten overlap | 75 | 38.4 30.2–48.9ROR 38.5 · calibrated p 8e-5 ✓ | 33.8 EB05 27.8 · IC025 +4.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.5 (5.0–8.5) | Not in label — unassessed | serious n=75 · 100% clinician | not reported in cached trials |
| Toxic optic neuropathy | 49 | 37.7 28.0–50.8ROR 37.8 · calibrated p 1e-4 ✓ | 33.1 EB05 26.0 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 15.1 (10.1–22.4) | Not in label — unassessed | serious n=49 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Selective eating disorder | 99 | 35.8 29.1–44.1ROR 35.9 · calibrated p 1e-4 ✓ | 31.8 EB05 26.9 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.3 (5.0–7.9) | Not in label — unassessed | serious n=99 | not reported in cached trials |
| Focal dyscognitive seizures | 120 | 34.5 28.5–41.6ROR 34.5 · calibrated p 1e-4 ✓ | 30.8 EB05 26.4 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.3 (1.9–2.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=119 | not reported in cached trials |
| Myoclonic epilepsy | 150 | 33.3 28.1–39.4ROR 33.4 · calibrated p 2e-4 ✓ | 29.9 EB05 26.1 · IC025 +4.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.9 (2.4–3.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=149 | not reported in cached trials |
| Pleurothotonus | 90 | 32.2 25.9–40.0ROR 32.2 · calibrated p 2e-4 ✓ | 28.9 EB05 24.2 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.2 (4.9–8.0) | Not in label — unassessed | serious n=88 · 100% clinician | not reported in cached trials |
| Exomphalos | 53 | 31.8 24.0–42.3ROR 31.9 · calibrated p 2e-4 ✓ | 28.5 EB05 22.6 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 15.1 (10.3–22.0) | Not in label — unassessed | serious n=51 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Eosinophilic myocarditis | 69 | 30.6 23.9–39.3ROR 30.7 · calibrated p 3e-4 ✓ | 27.6 EB05 22.6 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 15.1 (10.8–21.0) | Not in label — unassessed | serious n=69 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Brugada syndrome | 95 | 30.1 24.3–37.1ROR 30.1 · calibrated p 3e-4 ✓ | 27.2 EB05 22.9 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.4 (5.8–9.5) | Not in label — unassessed | serious n=94 · ♀ 30% (drug 66%) · 100% clinician | not reported in cached trials |
| Change in seizure presentation | 60 | 29.5 22.7–38.5ROR 29.6 · calibrated p 4e-4 ✓ | 26.7 EB05 21.5 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.0 (2.3–4.0) | Labeled (related wording) related wording | serious n=59 | not reported in cached trials |
| Atonic seizures | 72 | 29.2 22.9–37.1ROR 29.2 · calibrated p 4e-4 ✓ | 26.4 EB05 21.7 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.5 (1.9–3.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=67 | not reported in cached trials |
| Hypospadias | 186 | 29.1 25.0–33.8ROR 29.2 · calibrated p 3e-4 ✓ | 26.5 EB05 23.4 · IC025 +4.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.0 (4.2–5.9) | Not in label — unassessed | serious n=186 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Coarctation of the aorta | 87 | 28.8 23.1–35.9ROR 28.8 · calibrated p 4e-4 ✓ | 26.1 EB05 21.8 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.4 (5.8–9.6) | Not in label — unassessed | serious n=86 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Anticonvulsant drug level decreased | 127 | 28.7 23.9–34.4ROR 28.7 · calibrated p 4e-4 ✓ | 26.1 EB05 22.5 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.7 (2.3–3.3) | Lab value / disease marker | serious n=110 | not reported in cached trials |
| Spina bifida | 184 | 28.1 24.2–32.7ROR 28.2 · calibrated p 4e-4 ✓ | 25.7 EB05 22.7 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.9 (4.2–5.8) | Not in label — unassessed | serious n=184 · ♀ 100% (drug 66%) · 92% clinician | not reported in cached trials |
| Agitation neonatal | 80 | 26.9 21.4–33.8ROR 26.9 · calibrated p 5e-4 ✓ | 24.6 EB05 20.4 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.8 (5.2–8.9) | Not in label — unassessed | serious n=80 | not reported in cached trials |
| Anal atresia | 44 | 26.2 19.3–35.7ROR 26.2 · calibrated p 7e-4 ✓ | 23.9 EB05 18.5 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 9.2 (6.3–13.4) | Not in label — unassessed | serious n=44 · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 257 | 26.1 22.9–29.6ROR 26.2 · calibrated p 6e-4 ✓ | 24.0 EB05 21.6 · IC025 +4.3 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.9 (3.4–4.4) | Not in label — unassessed | serious n=257 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Infantile apnoea | 66 | 25.9 20.2–33.4ROR 26.0 · calibrated p 7e-4 ✓ | 23.7 EB05 19.3 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 12.8 (9.2–17.7) | Not in label — unassessed | serious n=66 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Respiratory disorder neonatal | 129 | 25.9 21.6–31.0ROR 25.9 · calibrated p 6e-4 ✓ | 23.8 EB05 20.5 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.3 (5.1–7.7) | Not in label — unassessed | serious n=129 · ♀ 41% (drug 66%) | not reported in cached trials |
| Dyspraxia | 45 | 25.7 19.0–34.9ROR 25.8 · calibrated p 8e-4 ✓ | 23.5 EB05 18.3 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 9.7 (6.7–14.1) | Labeled adverse reaction exact term | serious n=44 · ♀ 0% (drug 66%) | not reported in cached trials |
| Petit mal epilepsy | 408 | 25.6 23.2–28.3ROR 25.8 · calibrated p 6e-4 ✓ | 23.6 EB05 21.7 · IC025 +4.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.1 (2.8–3.5) | Labeled (related wording) related wording | serious n=398 | not reported in cached trials |
| Anticonvulsant drug level increased | 130 | 25.5 21.3–30.5ROR 25.5 · calibrated p 7e-4 ✓ | 23.4 EB05 20.3 · IC025 +4.1 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.3 (1.9–2.8) | Lab value / disease marker | serious n=128 · 100% clinician | not reported in cached trials |
| Dysmetria | 48 | 25.4 18.9–34.1ROR 25.4 · calibrated p 8e-4 ✓ | 23.3 EB05 18.2 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.4 (4.6–9.0) | Not in label — unassessed | serious n=48 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Dysmorphism | 189 | 25.3 21.8–29.4ROR 25.4 · calibrated p 7e-4 ✓ | 23.3 EB05 20.7 · IC025 +4.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.0 (3.4–4.7) | Not in label — unassessed | serious n=189 · ♀ 38% (drug 66%) | not reported in cached trials |
| Tonic convulsion | 105 | 23.8 19.5–29.0ROR 23.8 · calibrated p 1e-3 ✓ | 22.0 EB05 18.7 · IC025 +4.0 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.9 (2.4–3.6) | Not in label — unassessed | serious n=101 · 100% clinician | not reported in cached trials |
| Lip erosion | 55 | 23.7 18.0–31.2ROR 23.7 · calibrated p 0.001 ✓ | 21.8 EB05 17.4 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.0 (2.2–4.0) | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Foetal anticonvulsant syndrome | 89 | 23.5 19.0–29.2ROR 23.6 · calibrated p 0.001 ✓ | 21.8 EB05 18.2 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.9 (2.3–3.6) | Not in label — unassessed | serious n=89 | not reported in cached trials |
| Meningomyelocele | 45 | 23.5 17.4–31.9ROR 23.5 · calibrated p 0.001 ✓ | 21.7 EB05 16.8 · IC025 +3.7 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.7 (5.4–11.0) | Not in label — unassessed | serious n=45 · 100% clinician | not reported in cached trials |
| Syndactyly | 61 | 23.3 18.0–30.3ROR 23.4 · calibrated p 0.001 ✓ | 21.5 EB05 17.4 · IC025 +3.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 7.7 (5.6–10.4) | Not in label — unassessed | serious n=61 | not reported in cached trials |
| Polydactyly | 84 | 23.1 18.5–28.8ROR 23.1 · calibrated p 0.001 ✓ | 21.3 EB05 17.8 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 6.0 (4.7–7.7) | Not in label — unassessed | serious n=84 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Cleft lip and palate | 82 | 23.0 18.4–28.8ROR 23.0 · calibrated p 0.001 ✓ | 21.3 EB05 17.7 · IC025 +3.9 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.2 (4.0–6.7) | Not in label — unassessed | serious n=82 · 100% clinician | 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 | 3,772 | 15.715.2–16.2 | signal |
| Seizure | 7,093 | 11.010.8–11.2 | signal |
| Suicidality | 6,292 | 7.77.5–7.9 | signal |
| Extrapyramidal | 1,352 | 3.83.6–4.0 | signal |
| Depression | 2,945 | 3.13.0–3.2 | signal |
| Hyponatraemia | 681 | 2.52.3–2.7 | signal |
| Rhabdomyolysis / myopathy | 675 | 2.52.3–2.7 | signal |
| Liver injury | 2,128 | 2.12.0–2.2 | raised |
| Arrhythmia / qt | 1,012 | 1.51.4–1.6 | raised |
| Fall / fracture | 1,961 | 1.51.5–1.6 | raised |
| Pancreatitis | 317 | 1.21.0–1.3 | raised |
| Thrombocytopenia | 727 | 1.00.9–1.0 | no difference |
| Serious infection | 2,354 | 0.90.9–0.9 | lower than other drugs |
| Kidney injury | 1,387 | 0.90.8–0.9 | lower than other drugs |
| Neutropenia / agranulocytosis | 692 | 0.80.8–0.9 | lower than other drugs |
| Dependence / withdrawal | 787 | 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 Chewable Dispersible 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 (0 of 40 signal terms matched).
- NCT01602510 — Lamotrigine Phase III Study in Bipolar I Disorder (N=265, PHASE3; 92 AE terms posted; arms: Randomized Placebo; Randomized Lamotrigine 200 mg/Day)
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) | 6,209 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.594 | 1.4 EB05 1.4 · IC025 +0.4 vs other Anti-epileptic Agents: PRR 3.1 (3.0–3.1) | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 2.1 | not reported in cached trials |
| Seizure | 4,294 | 11.4 11.1–11.8ROR 12.1 · calibrated p 0.016 ✓ | 11.0 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 2.8 (2.7–2.9) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 8.0 · serious PRR 7.8 | not reported in cached trials |
| Toxicity to various agents | 3,928 | 7.0 6.8–7.3ROR 7.4 · calibrated p 0.084 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Anti-epileptic Agents: PRR 4.6 (4.5–4.8) | Labeled (related wording) related wording | age-adj. PRR 6.0 · serious PRR 4.9 · 96% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 3,471 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.431 | 1.2 EB05 1.1 · IC025 +0.2 vs other Anti-epileptic Agents: PRR 3.2 (3.0–3.3) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Drug interaction | 3,257 | 6.2 5.9–6.4ROR 6.4 · calibrated p 0.127 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.2 (3.1–3.3) | Reporting / coding artifact | age-adj. PRR 5.5 · serious PRR 4.5 | not reported in cached trials |
| Completed suicide (death by suicide) | 3,072 | 11.1 10.7–11.5ROR 11.6 · calibrated p 0.019 ✓ | 10.7 EB05 10.4 · IC025 +3.4 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.2 (5.0–5.4) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 8.7 · serious PRR 7.6 · 98% clinician | not reported in cached trials |
| Fatigue (tiredness) | 2,987 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.398 | 1.1 EB05 1.1 · IC025 +0.1 vs other Anti-epileptic Agents: PRR 3.3 (3.2–3.4) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.1 | NCT01602510: 2/131 (1.5%) on Lamotrigine Chewable Dispersible; 3/133 (2.3%) control |
| Dizziness | 2,981 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.830 | 1.8 EB05 1.7 · IC025 +0.8 vs other Anti-epileptic Agents: PRR 3.5 (3.4–3.6) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.7 | NCT01602510: 2/131 (1.5%) on Lamotrigine Chewable Dispersible; 1/133 (0.8%) control |
| Nausea | 2,969 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.381 | 1.1 EB05 1.1 · IC025 +0.1 vs other Anti-epileptic Agents: PRR 3.5 (3.3–3.6) | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.1 | NCT01602510: 3/131 (2.3%) on Lamotrigine Chewable Dispersible; 1/133 (0.8%) control |
| Rash | 2,875 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.943 | 2.0 EB05 1.9 · IC025 +0.9 vs other Anti-epileptic Agents: PRR 3.0 (2.9–3.2) | Labeled — boxed warning exact term | age-adj. PRR 1.8 · serious PRR 2.3 | NCT01602510: 2/131 (1.5%) on Lamotrigine Chewable Dispersible; 2/133 (1.5%) control |
| Foetal exposure during pregnancy | 2,724 | 10.2 9.8–10.6ROR 10.5 · calibrated p 0.027 ✓ | 9.9 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other Anti-epileptic Agents: PRR 5.1 (4.9–5.3) | Reporting / coding artifact | serious PRR 7.1 · ♀ 40% (drug 66%) | not reported in cached trials |
| Headache | 2,700 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.495 | 1.3 EB05 1.2 · IC025 +0.3 vs other Anti-epileptic Agents: PRR 3.4 (3.3–3.6) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.4 | NCT01602510: 4/131 (3.1%) on Lamotrigine Chewable Dispersible; 4/133 (3.0%) control |
| Somnolence (drowsiness) | 2,574 | 3.8 3.7–4.0ROR 3.9 · calibrated p 0.395 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.1 (3.0–3.3) | Labeled adverse reaction exact term | age-adj. PRR 3.5 · serious PRR 3.8 | NCT01602510: 1/131 (0.8%) on Lamotrigine Chewable Dispersible; 1/133 (0.8%) control |
| Depression | 2,396 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.570 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Anti-epileptic Agents: PRR 3.4 (3.3–3.5) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.7 · serious PRR 2.6 | not reported in cached trials |
| Vomiting | 2,323 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.626 | 1.5 EB05 1.4 · IC025 +0.5 vs other Anti-epileptic Agents: PRR 3.3 (3.1–3.4) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.3 | 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.
- Postictal psychosis — n=46, PRR 124.5
- Overlap syndrome — n=110, PRR 55.8
- Developmental hip dysplasia — n=97, PRR 38.7
- Sjs-ten overlap — n=75, PRR 38.4
- Toxic optic neuropathy — n=49, PRR 37.7
- Selective eating disorder — n=99, PRR 35.8
- Pleurothotonus — n=90, PRR 32.2
- Exomphalos — n=53, PRR 31.8
- Eosinophilic myocarditis — n=69, PRR 30.6
- Brugada syndrome — n=95, PRR 30.1
✓ 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 Chewable Dispersible?
In FDA FAERS, the most frequently co-reported reaction terms for Lamotrigine Chewable Dispersible are seizure, toxicity to various agents, fatigue, dizziness, nausea, rash. 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 Chewable Dispersible 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 Chewable Dispersible 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 ae6522d4-d824-44aa-afe0-70cdcbd845af, effective 20230117; matched on
openfda.generic_name.exact:"LAMOTRIGINE CHEWABLE DISPERSIBLE") - 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, 1,286 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 CHEWABLE DISPERSIBLE, 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.