Drug Safety Information for ZARONTIN (Ethosuximide)

Safety-related Labeling Changes for ZARONTIN (ETHOSUXIMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ZARONTIN* (Ethosuximide)

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 ZARONTIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion93
2Drug ineffective54
3Petit mal epilepsy49
4Condition aggravated35
5Drug interaction26
6Grand mal convulsion26
7Epilepsy24
8Vomiting22
9Product quality issue21
10Pyrexia21
11Pyloric stenosis20
12Rash20
13Fall19
14Fatigue19
15Nausea16
16Blister15
17Aggression*15
18Headache*15
19Joint injury14
20Somnolence*14

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

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

Reason # of FDA Reports
1Epilepsy*779
2Convulsion281
3Product used for unknown indication176
4Petit mal epilepsy*170
5Myoclonic epilepsy20
6Partial seizures18
7Amnesia15
8Encephalopathy15
9Maternal exposure during pregnancy13
10Ill-defined disorder13

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


Types of Adverse Events for ZARONTIN

Total Reports Filed with FDA: 2334


Number of FDA Adverse Event Reports by Patient Age for ZARONTIN

Total Reports Filed with FDA: 2334*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethosuximide (Ethosuximide, Suxilep, Ethymal, Petnidan, Zarontin)

Charts are based on 2334 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 ZARONTIN Reviews and Review Summary .

Historical 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.