Drug Safety Information for ONFI (Clobazam)

FDA Safety-related Labeling Changes for ONFI (CLOBAZAM) Rx Drug: Safety Information Link

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Evaluating

Adverse Drug Reactions for ONFI* (Clobazam)

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 ONFI
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	928
2	Somnolence	358
3	Drug ineffective	335
4	Epilepsy	250
5	Drug interaction	233
6	Pyrexia	227
7	Fatigue	198
8	Fall	192
9	Aggression	186
10	Status epilepticus	174
11	Confusional state	173
12	Condition aggravated	166
13	Abnormal behaviour	156
14	Vomiting	155
15	Dizziness	151
16	Headache	130
17	Rash	124
18	Asthenia	123
19	Gait disturbance	116
20	Thrombocytopenia	115

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

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

	Reason	# of FDA Reports
1	Epilepsy	4470
2	Product used for unknown indication	3810
3	Convulsion	1536
4	Lennox-gastaut syndrome	392
5	Partial seizures	316
6	Temporal lobe epilepsy	235
7	Anxiety	234
8	Depression	127
9	Status epilepticus	120
10	Complex partial seizures	111

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

Types of Adverse Events for ONFI

Total Reports Filed with FDA: 21568

Number of FDA Adverse Event Reports by Patient Age for ONFI

Total Reports Filed with FDA: 21568*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clobazam (Frisium, Onfi, Urbanyl)

Charts are based on 21568 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.

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.