Drug Safety Information for CARBAMAZEPINE (Carbamazepine)

Safety-related Labeling Changes for TEGRETOL (CARBAMAZEPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for TEGRETOL-XR (CARBAMAZEPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for CARBATROL (CARBAMAZEPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for EQUETRO (CARBAMAZEPINE) Rx Drug: FDA Link

Adverse Drug Reactions for CARBAMAZEPINE* (Carbamazepine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CARBAMAZEPINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion3049
2Pyrexia1508
3Drug interaction1391
4Dizziness*1321
5Drug ineffective1200
6Nausea*1123
7Vomiting1104
8Rash1069
9Somnolence*1054
10Fall1007
11Headache*980
12Fatigue*940
13Toxicity to various agents922
14Epilepsy825
15Condition aggravated823
16Malaise807
17Pain785
18Asthenia771
19Confusional state*739
20Hyponatraemia687

* This side effect also appears in "Top 10 Side Effects of CARBAMAZEPINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CARBAMAZEPINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Epilepsy*21403
2Convulsion*12040
3Product used for unknown indication9617
4Trigeminal neuralgia*5095
5Bipolar disorder*3577
6Depression1385
7Neuralgia1369
8Partial seizures1296
9Grand mal convulsion1192
10Complex partial seizures*1005

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CARBAMAZEPINE

Total Reports Filed with FDA: 138535


Number of FDA Adverse Event Reports by Patient Age for CARBAMAZEPINE

Total Reports Filed with FDA: 138535*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Carbamazepine (Equetro, Tegretol-xr, Neurotol, Finlepsin, Timonil retard, Carbamazepine, Epitol, Carbatrol, Tegretol, Teril)

Charts are based on 138535 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CARBAMAZEPINE Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on CARBAMAZEPINE's side effects.