Drug Safety Information for CLONAZEPAM (Clonazepam)

Safety-related Labeling Changes for KLONOPIN (CLONAZEPAM) Rx Drug: FDA Link

Safety-related Labeling Changes for KLONOPIN RAPIDLY DISINTEGRATING (CLONAZEPAM) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for CLONAZEPAM* (Clonazepam)

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 CLONAZEPAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective4118
2Nausea3927
3Anxiety*3501
4Depression*3411
5Fatigue*3312
6Headache*3300
7Pain3063
8Insomnia*3035
9Dizziness*3015
10Dyspnoea2454
11Fall2401
12Somnolence*2398
13Vomiting2349
14Diarrhoea2348
15Weight increased2250
16Convulsion2242
17Completed suicide2192
18Asthenia2188
19Malaise1971
20Tremor1872

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

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

Reason # of FDA Reports
1Product used for unknown indication34018
2Anxiety*25347
3Depression*6989
4Insomnia*6876
5Sleep disorder4791
6Epilepsy3599
7Convulsion*2972
8Restless legs syndrome*2868
9Panic attack*2700
10Bipolar disorder2093

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


Types of Adverse Events for CLONAZEPAM

Total Reports Filed with FDA: 323208


Number of FDA Adverse Event Reports by Patient Age for CLONAZEPAM

Total Reports Filed with FDA: 323208*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clonazepam (Klonopin wafer, Valpax, Antelepsin, Rivotril, Clonazepam, Klonopin)

Charts are based on 323208 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 CLONAZEPAM 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.