Drug Safety Information for SARAFEM (Fluoxetine hydrochloride)

Safety-related Labeling Changes for PROZAC (FLUOXETINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for PROZAC WEEKLY (FLUOXETINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for SYMBYAX (FLUOXETINE HYDROCHLORIDE; OLANZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for SARAFEM (FLUOXETINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for SARAFEM* (Fluoxetine 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 SARAFEM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*3009
2Depression2991
3Drug ineffective2649
4Fatigue*2446
5Anxiety*2433
6Headache*2323
7Pain2222
8Dizziness2081
9Dyspnoea2068
10Vomiting1941
11Diarrhoea1759
12Insomnia*1724
13Completed suicide1695
14Fall1695
15Drug interaction1581
16Asthenia1492
17Suicidal ideation1483
18Weight increased*1479
19Malaise1360
20Tremor1344

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

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

Reason # of FDA Reports
1Depression*50080
2Product used for unknown indication29346
3Anxiety*4875
4Obsessive-compulsive disorder*2195
5Major depression*1709
6Bipolar disorder*1437
7Antidepressant therapy905
8Affective disorder632
9Depressed mood586
10Ill-defined disorder574

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


Types of Adverse Events for SARAFEM

Total Reports Filed with FDA: 250602


Number of FDA Adverse Event Reports by Patient Age for SARAFEM

Total Reports Filed with FDA: 250602*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluoxetine hydrochloride (Selfemra, Fluoxetine, Fluox, Fluoxetina, Fluoxetine hcl, Prozac weekly, Sarafem, Prozac)

Charts are based on 250602 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 SARAFEM Reviews and Review Summary .

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.

Visit   DrugInformer.com more on SARAFEM's side effects.