Drug Safety Information for ANAFRANIL (Clomipramine hydrochloride)

FDA Safety-related Labeling Changes for ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for ANAFRANIL* (Clomipramine hydrochloride)

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 ANAFRANIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction218
2Toxicity to various agents167
3Depression154
4Overdose149
5Confusional state142
6Fall140
7Anxiety*139
8Somnolence*133
9Drug ineffective129
10Agitation128
11Tremor*124
12Pyrexia119
13Suicide attempt118
14Nausea116
15Dizziness*98
16Suicidal ideation96
17Malaise95
18Hyperhidrosis*94
19Dyspnoea93
20Headache93

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

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

Reason # of FDA Reports
1Depression*2710
2Product used for unknown indication1728
3Obsessive-compulsive disorder*879
4Bipolar disorder283
5Major depression276
6Anxiety*199
7Suicide attempt85
8Panic disorder74
9Schizophrenia71
10Postpartum depression66

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


Types of Adverse Events for ANAFRANIL

Total Reports Filed with FDA: 17266


Number of FDA Adverse Event Reports by Patient Age for ANAFRANIL

Total Reports Filed with FDA: 17266*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clomipramine hydrochloride (Chlomipramine, Clomipramine, Chlorimipramine, Clomipramina, Anafranil)

Charts are based on 17266 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 ANAFRANIL 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.