Drug · FAERS side-effect profile with label screen
Eslicarbazepine side effects: what 3,246 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Eslicarbazepine Acetate (Eslicarbazepine Acetate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,246 reports · 69% serious · 94 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. ( 1 )
FDA label, Indications and Usage
Boxed warning
None in the current 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 adverse reaction 17Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 3Not in label — unassessed 14
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.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 75 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 |
|---|---|---|---|---|---|---|
| Seizure | 1,002 | 56.9 54.0–59.9ROR 81.8 · χ² 54,762 / p <1e-300 | 56.3 EB05 53.5 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.4 · 71% consumer | no trial data cached |
| Generalised tonic-clonic seizure | 117 | 46.5 38.9–55.6ROR 48.2 · χ² 5,130 / p <1e-300 | 45.8 EB05 39.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 37.9 | no trial data cached |
| Hyponatraemia (low sodium) | 172 | 19.8 17.1–22.9ROR 20.9 · χ² 3,054 / p <1e-300 | 19.7 EB05 17.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 | no trial data cached |
| Status epilepticus | 31 | 17.7 12.5–25.2ROR 17.9 · χ² 472 / p 6e-105 | 17.5 EB05 12.8 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.7 · ♀ 33% (drug 57%) | no trial data cached |
| Blood sodium decreased | 48 | 16.5 12.5–21.9ROR 16.8 · χ² 683 / p 6e-151 | 16.3 EB05 12.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 78% (drug 57%) · 75% consumer | no trial data cached |
| Ataxia | 26 | 14.1 9.6–20.7ROR 14.2 · χ² 303 / p 3e-68 | 13.7 EB05 9.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Epilepsy | 55 | 11.7 9.0–15.2ROR 11.8 · χ² 525 / p 2e-116 | 11.4 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Decreased activity | 17 | 10.3 6.4–16.5ROR 10.3 · χ² 133 / p 5e-31 | 9.0 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Prescribed underdose | 30 | 9.7 6.8–13.9ROR 9.8 · χ² 226 / p 2e-51 | 9.0 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 87% consumer | no trial data cached |
| Hypersomnia | 42 | 9.5 7.0–12.8ROR 9.6 · χ² 310 / p 9e-70 | 9.0 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 79% consumer | no trial data cached |
| Therapy interrupted | 99 | 9.3 7.6–11.3ROR 9.5 · χ² 724 / p 8e-160 | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 · 92% consumer | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 35 | 8.9 6.4–12.3ROR 8.9 · χ² 236 / p 1e-53 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 | no trial data cached |
| Diplopia (double vision) | 35 | 8.7 6.3–12.1ROR 8.8 · χ² 231 / p 2e-52 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Prescribed overdose | 26 | 8.7 5.9–12.7ROR 8.7 · χ² 169 / p 6e-39 | 7.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 77% consumer | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 12 | 7.6 4.3–13.4ROR 7.6 · χ² 63 / p 1e-15 | 6.2 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Hepatic cytolysis | 14 | 7.4 4.4–12.5ROR 7.4 · χ² 71 / p 2e-17 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Underdose | 77 | 6.8 5.5–8.5ROR 7.0 · χ² 377 / p 3e-84 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 | no trial data cached |
| Somnolence (drowsiness) | 191 | 6.1 5.4–7.0ROR 6.5 · χ² 824 / p 2e-181 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Muscle rigidity | 11 | 5.9 3.3–10.7ROR 6.0 · χ² 40 / p 1e-10 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Anger | 30 | 5.7 4.0–8.2ROR 5.8 · χ² 112 / p 2e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · ♀ 32% (drug 57%) · 79% consumer | no trial data cached |
| Mydriasis | 11 | 5.5 3.1–10.0ROR 5.6 · χ² 37 / p 7e-10 | 4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Altered state of consciousness | 18 | 5.4 3.4–8.6ROR 5.4 · χ² 60 / p 4e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Coordination abnormal | 11 | 5.1 2.8–9.1ROR 5.1 · χ² 32 / p 8e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Irritability | 47 | 5.0 3.8–6.7ROR 5.1 · χ² 149 / p 2e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · ♀ 79% (drug 57%) | no trial data cached |
| Agitation | 55 | 4.8 3.7–6.3ROR 4.9 · χ² 163 / p 1e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Balance disorder | 63 | 4.7 3.7–6.0ROR 4.8 · χ² 181 / p 2e-41 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 73% consumer | no trial data cached |
| Aphasia (loss of speech) | 21 | 4.5 2.9–6.9ROR 4.5 · χ² 53 / p 1e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Hallucination, auditory | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Sedation | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 1e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 4.4 3.2–6.0ROR 4.4 · χ² 97 / p 4e-23 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · ♀ 79% (drug 57%) | no trial data cached |
| Head discomfort | 12 | 4.4 2.5–7.7ROR 4.4 · χ² 28 / p 5e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 62 | 4.4 3.4–5.6ROR 4.4 · χ² 158 / p 1e-36 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Coma | 32 | 4.3 3.1–6.1ROR 4.4 · χ² 79 / p 3e-19 | 4.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Dysarthria (slurred speech) | 25 | 4.3 2.9–6.3ROR 4.3 · χ² 60 / p 5e-15 | 4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Memory impairment | 91 | 4.3 3.5–5.2ROR 4.4 · χ² 226 / p 2e-51 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 78% consumer | no trial data cached |
| Mood swings | 21 | 4.3 2.8–6.5ROR 4.3 · χ² 49 / p 1e-12 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 2e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Aggression | 32 | 4.1 2.9–5.8ROR 4.2 · χ² 73 / p 8e-18 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · ♀ 23% (drug 57%) | no trial data cached |
| Rash maculo-papular | 14 | 4.1 2.4–6.9ROR 4.1 · χ² 30 / p 3e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Cognitive disorder | 29 | 4.0 2.8–5.8ROR 4.1 · χ² 63 / p 1e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · ♀ 33% (drug 57%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seizure | 1,002 | 56.9 54.0–59.9ROR 81.8 · χ² 54,762 / p <1e-300 | 56.3 EB05 53.5 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.4 · 71% consumer | no trial data cached |
| Somnolence (drowsiness) | 191 | 6.1 5.4–7.0ROR 6.5 · χ² 824 / p 2e-181 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Hyponatraemia (low sodium) | 172 | 19.8 17.1–22.9ROR 20.9 · χ² 3,054 / p <1e-300 | 19.7 EB05 17.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 | no trial data cached |
| Generalised tonic-clonic seizure | 117 | 46.5 38.9–55.6ROR 48.2 · χ² 5,130 / p <1e-300 | 45.8 EB05 39.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 37.9 | no trial data cached |
| Therapy interrupted | 99 | 9.3 7.6–11.3ROR 9.5 · χ² 724 / p 8e-160 | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 · 92% consumer | no trial data cached |
| Feeling abnormal | 94 | 2.5 2.1–3.1ROR 2.6 · χ² 86 / p 9e-21 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 83% consumer | no trial data cached |
| Memory impairment | 91 | 4.3 3.5–5.2ROR 4.4 · χ² 226 / p 2e-51 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 78% consumer | no trial data cached |
| Inappropriate schedule of product administration | 87 | 3.2 2.6–3.9ROR 3.2 · χ² 129 / p 4e-30 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 89% consumer | no trial data cached |
| Underdose | 77 | 6.8 5.5–8.5ROR 7.0 · χ² 377 / p 3e-84 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 | no trial data cached |
| Balance disorder | 63 | 4.7 3.7–6.0ROR 4.8 · χ² 181 / p 2e-41 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 73% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 62 | 4.4 3.4–5.6ROR 4.4 · χ² 158 / p 1e-36 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Agitation | 55 | 4.8 3.7–6.3ROR 4.9 · χ² 163 / p 1e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Epilepsy | 55 | 11.7 9.0–15.2ROR 11.8 · χ² 525 / p 2e-116 | 11.4 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Overdose | 48 | 1.4 1.1–1.9ROR 1.4 · χ² 6 / p 0.008 | 1.4 EB05 1.1 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.3 · 71% consumer | no trial data cached |
| Blood sodium decreased | 48 | 16.5 12.5–21.9ROR 16.8 · χ² 683 / p 6e-151 | 16.3 EB05 12.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 78% (drug 57%) · 75% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Prescribed underdose — n=30, PRR 9.7
- Prescribed overdose — n=26, PRR 8.7
- Agitation — n=55, PRR 4.8
- Coma — n=32, PRR 4.3
- Mood swings — n=21, PRR 4.3
- Aggression — n=32, PRR 4.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Eslicarbazepine?
In FDA FAERS, the most frequently co-reported reaction terms for Eslicarbazepine are seizure, somnolence, hyponatraemia, generalised tonic-clonic seizure, feeling abnormal, memory impairment. 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 Eslicarbazepine have an FDA boxed warning?
No. The FDA label retrieved for Eslicarbazepine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Eslicarbazepine 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 22d08671-ac0d-4e3d-8195-929bbb021125, effective 20260415; matched on
openfda.generic_name.exact:"ESLICARBAZEPINE ACETATE") - 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, 115 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.