Drug Safety Information for CITALOPRAM HYDROBROMIDE (Citalopram hydrobromide)

Safety-related Labeling Changes for CELEXA (CITALOPRAM HYDROBROMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for CITALOPRAM HYDROBROMIDE* (Citalopram hydrobromide)

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 CITALOPRAM HYDROBROMIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*2338
2Depression1995
3Fatigue*1941
4Anxiety*1814
5Pain1707
6Headache*1673
7Dizziness*1626
8Vomiting1584
9Fall1502
10Drug ineffective1500
11Diarrhoea1493
12Dyspnoea1470
13Drug interaction1230
14Asthenia1193
15Insomnia*1156
16Confusional state1080
17Tremor1058
18Malaise1001
19Suicidal ideation951
20Weight increased*949

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

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

Reason # of FDA Reports
1Depression*36248
2Product used for unknown indication17242
3Anxiety*4374
4Depressed mood1063
5Bipolar disorder*944
6Antidepressant therapy842
7Major depression*777
8Obsessive-compulsive disorder*623
9Panic attack*357
10Affective disorder321

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


Types of Adverse Events for CITALOPRAM HYDROBROMIDE

Total Reports Filed with FDA: 189787


Number of FDA Adverse Event Reports by Patient Age for CITALOPRAM HYDROBROMIDE

Total Reports Filed with FDA: 189787*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Citalopram hydrobromide (Perrigo citalopram, Cipramil, Celexa)

Charts are based on 189787 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 CITALOPRAM HYDROBROMIDE 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.