Drug Safety Information for FINASTERIDE (Finasteride)

FDA Safety-related Labeling Changes for PROSCAR (FINASTERIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for PROPECIA (FINASTERIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for FINASTERIDE* (Finasteride)

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 FINASTERIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Erectile dysfunction*1974
2Sexual dysfunction1678
3Depression*1408
4Anxiety*1293
5Cognitive disorder1051
6Libido decreased*951
7Fatigue*909
8Drug ineffective712
9Dizziness620
10Asthenia557
11Loss of libido*553
12Dyspnoea548
13Insomnia479
14Ejaculation disorder449
15Diarrhoea437
16Headache409
17Nausea407
18Pain*387
19Ejaculation failure381
20Back pain373

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

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

Reason # of FDA Reports
1Alopecia*16669
2Androgenetic alopecia*10324
3Product used for unknown indication4804
4Benign prostatic hyperplasia*3860
5Prostatomegaly*1621
6Prostatic disorder1132
7Prostate cancer529
8Prophylaxis500
9Alopecia areata247
10Prostatic adenoma188

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


Types of Adverse Events for FINASTERIDE

Total Reports Filed with FDA: 73413


Number of FDA Adverse Event Reports by Patient Age for FINASTERIDE

Total Reports Filed with FDA: 73413*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Finasteride (Chibro-proscar, Finasteride, Propecia, Proscar)

Charts are based on 73413 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 FINASTERIDE 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.