What the label lists and what reports show
Eslicarbazepine side effects
Eslicarbazepine's FDA label: “Most common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.” FAERS holds 3,247 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (222 reports).
- Generic listed
Check it at the source: the eslicarbazepine FDA label on DailyMed (effective November 10, 2023, Sumitomo Pharma America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of APTIOM?See “ What is the most important information I should know about APTIOM? ” APTIOM may cause other serious side effects including: Nervous system problems. APTIOM may cause problems that can affect your nervous system. Symptoms of nervous system problems include: dizziness trouble concentrating trouble walking or with coordination vision problems feeling sleepy and tired Liver problems. APTIOM may affect your liver. […]
Source: FDA drug label, Sumitomo Pharma America, Inc., effective November 10, 2023 (SPL set 3d0c9554-eaeb-4694-8089-00133fcadce3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.
Table 4: Adverse Reactions Incidence in Pooled Controlled Clinical Trials of Adjunctive Therapy in Adults (Events ≥2% of Patients in the APTIOM 800 mg or 1200 mg Dose Group and More Frequent Than in the Placebo Group)
| Reaction | (N=426) % | (N=415) % | (N=410) % |
|---|---|---|---|
| Ear and labyrinth disorders Vertigo | <1 | 2 | 6 |
| Infections and Infestations Urinary tract infections | 1 | 2 | 2 |
| Injury, poisoning and procedural complications Fall | 1 | 3 | 1 |
| Metabolism and nutrition disorders Hyponatremia | <1 | 2 | 2 |
| Respiratory, thoracic and mediastinal disorders Cough | 1 | 2 | 1 |
| Skin and subcutaneous tissue disorders Rash | 1 | 1 | 3 |
| Vascular disorders Hypertension | 1 | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Serious Dermatologic Reactions [see Warnings and Precautions ( 5.2 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.4 )] Hyponatremia [see Warnings and Precautions ( 5.5 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.6 )] Drug Induced Liver Injury [see Warnings and Precautions ( 5.8 )] Abnormal Thyroid Function Tests [see Warnings and Precautions ( 5.9 )] Pancytopenia, Agranulocytosis, and Leukopenia [see Warnings and Precautions ( 5.10 )] Most common adverse reactions in adult patients receiving APTIOM (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. ( 6.1 ) Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Sumitomo Pharma America, Inc., effective November 10, 2023 (SPL set 3d0c9554-eaeb-4694-8089-00133fcadce3), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,247 reports list eslicarbazepine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 693 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 15 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eslicarbazepine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions