Drug Safety Information for LEVETIRACETAM (Levetiracetam)

Safety-related Labeling Changes for KEPPRA (LEVETIRACETAM) Rx Drug: FDA Link

Safety-related Labeling Changes for KEPPRA XR (LEVETIRACETAM) Rx Drug: FDA Link

Safety-related Labeling Changes for LEVETIRACETAM IN SODIUM CHLORIDE (LEVETIRACETAM) Rx Drug: FDA Link

Safety-related Labeling Changes for SPRITAM (LEVETIRACETAM) Rx Drug: FDA Link

Adverse Drug Reactions for LEVETIRACETAM* (Levetiracetam)

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 LEVETIRACETAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion5172
2Drug ineffective1342
3Fatigue*1217
4Somnolence*991
5Headache936
6Vomiting889
7Dizziness*888
8Fall871
9Nausea870
10Grand mal convulsion842
11Epilepsy826
12Pregnancy825
13Condition aggravated814
14Confusional state770
15Thrombocytopenia764
16Pyrexia750
17Asthenia743
18Death728
19Drug interaction710
20Depression*686

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

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

Reason # of FDA Reports
1Epilepsy*21361
2Convulsion*18483
3Product used for unknown indication11204
4Partial seizures*1846
5Convulsion prophylaxis1210
6Grand mal convulsion*1113
7Complex partial seizures*836
8Status epilepticus765
9Prophylaxis504
10Temporal lobe epilepsy*328

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


Types of Adverse Events for LEVETIRACETAM

Total Reports Filed with FDA: 116050


Number of FDA Adverse Event Reports by Patient Age for LEVETIRACETAM

Total Reports Filed with FDA: 116050*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levetiracetam (Keppra xr, Elepsia xr, Spritam, Levetiractam, Levetiracetam, Keppra)

Charts are based on 116050 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 LEVETIRACETAM 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.