What the label lists and what reports show
Oxcarbazepine side effects
Oxcarbazepine's FDA label: “The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and …” FAERS holds 31,342 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 (1,518 reports).
- Generic listed
Check it at the source: the oxcarbazepine FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); 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 TRILEPTAL?See “ What is the most important information I should know about TRILEPTAL? ” TRILEPTAL may cause other serious side effects, including: trouble concentrating problems with your speech and language feeling confused feeling sleepy and tired trouble with walking and coordination seizures that can happen more often or become worse, especially in children Get medical help right away if you have any of the symptoms listed above or listed in “What is the most important information I should know about TRILEPTAL?” The most common side effects of TRILEPTAL include: • dizziness • problems with vision • sleepiness • trembling • double vision • problems with walking and coordination (unsteadiness) • tiredness • rash • nausea • headache • vomiting These are not all the possible side effects of TRILEPTAL. Tell your healthcare provider if you have any side effect that bothers you or does not go away. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 3: Adverse Reactions in a Controlled Clinical Study of Adjunctive Therapy With TRILEPTAL in Adults
| Body system/ Adverse reaction | TRILEPTAL 600 N = 163 % | TRILEPTAL 1200 N = 171 % | TRILEPTAL 2400 N = 126 % | Placebo N = 166 % |
|---|---|---|---|---|
| Fatigue | 15 | 12 | 15 | 7 |
| Asthenia | 6 | 3 | 6 | 5 |
| Leg edema | 2 | 1 | 2 | 1 |
| Increased weight | 1 | 2 | 2 | 1 |
| Feeling abnormal | 0 | 1 | 2 | 0 |
| Hypotension | 0 | 1 | 2 | 0 |
| Nausea | 15 | 25 | 29 | 10 |
| Vomiting | 13 | 25 | 36 | 5 |
| Abdominal pain | 10 | 13 | 11 | 5 |
| Diarrhea | 5 | 6 | 7 | 6 |
| Dyspepsia | 5 | 5 | 6 | 2 |
| Constipation | 2 | 2 | 6 | 4 |
| Gastritis | 2 | 1 | 2 | 1 |
| Hyponatremia | 3 | 1 | 2 | 1 |
| Muscle weakness | 1 | 2 | 2 | 0 |
| Sprains and strains | 0 | 2 | 2 | 1 |
| Headache | 32 | 28 | 26 | 23 |
| Dizziness | 26 | 32 | 49 | 13 |
| Somnolence | 20 | 28 | 36 | 12 |
| Ataxia | 9 | 17 | 31 | 5 |
| Nystagmus | 7 | 20 | 26 | 5 |
| Abnormal gait | 5 | 10 | 17 | 1 |
| Insomnia | 4 | 2 | 3 | 1 |
| Tremor | 3 | 8 | 16 | 5 |
| Nervousness | 2 | 4 | 2 | 1 |
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 serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions (5.1)] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2)] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3)] Serious Dermatological Reactions [see Warnings and Precautions (5.4)] Suicidal Behavior and Ideation [see Warnings and Precautions (5. 5 )] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5. 7 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5. 8 )] Hematologic Events [see Warnings and Precautions (5. 9 )] The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b), via openFDA; the full label on DailyMed
What do FAERS reports show?
31,342 reports list oxcarbazepine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,175 are coded as a death and 9,792 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 20 reactions below, 15 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?
- Oxcarbazepine: 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