What the label lists and what reports show
Carbamazepine side effects
Carbamazepine's FDA label lists its adverse reactions in its own words. FAERS holds 66,615 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 fall (3,074 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the carbamazepine FDA label on DailyMed (effective August 20, 2026, 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 TEGRETOL?See “What is the most important information I should know about TEGRETOL?” TEGRETOL may cause other serious side effects. These include: Irregular heartbeat - symptoms include: Fast, slow, or pounding heartbeat Shortness of breath Feeling lightheaded Fainting Liver problems - symptoms include: yellowing of your skin or the whites of your eyes dark urine pain on the right side of your stomach area (abdominal pain) easy bruising loss of appetite nausea or vomiting 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 TEGRETOL?” The most common side effects of TEGRETOL include: dizziness drowsiness problems with walking and coordination (unsteadiness) nausea vomiting These are not all the possible side effects of TEGRETOL. For more information, ask your healthcare provider or pharmacist. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 20, 2026 (SPL set 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIf adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. …
(Incidence > 2% and greater than placebo)
This table is printed in the EQUETRO label published by Validus Pharmaceuticals LLC of August 19, 2025; the label quoted above does not print one.
| Adverse Reactions | EQUETRO ® (N = 251) | Placebo (N = 248) |
|---|---|---|
| Dizziness | 44% | 12% |
| Somnolence | 32% | 13% |
| Nausea | 29% | 10% |
| Vomiting | 18% | 3% |
| Ataxia | 15% | 0.4% |
| Constipation | 10% | 5% |
| Pruritus | 8% | 2% |
| Dry Mouth | 8% | 3% |
| Asthenia | 8% | 4% |
| Rash | 7% | 4% |
| Blurred vision | 6% | 2% |
| Speech Disorder | 6% | 0.4% |
| Hypertension | 3% | 0.4% |
| Paresthesia | 2% | 1% |
| Thinking abnormal | 2% | 0.4% |
| Tremor | 3% | 1% |
| Twitching | 2% | 1% |
| Vertigo | 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.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 20, 2026 (SPL set 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053), via openFDA; the full label on DailyMed
What do FAERS reports show?
66,615 reports list carbamazepine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,605 are coded as a death and 25,899 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 18 reactions below, 12 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?
- Carbamazepine: 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