Drug Safety Information for RAPAFLO (Silodosin)

Safety-related Labeling Changes for RAPAFLO (SILODOSIN) Rx Drug: FDA Link

Adverse Drug Reactions for RAPAFLO* (Silodosin)

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 RAPAFLO
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective94
2Dizziness*94
3Death74
4Diarrhoea71
5Fatigue69
6Dyspnoea61
7Loss of consciousness58
8Retrograde ejaculation*53
9Nausea52
10Headache*45
11Nasal congestion43
12Asthenia39
13Fall38
14Drug interaction37
15Syncope34
16Malaise32
17Pneumonia32
18Constipation29
19Off label use28
20Rash28

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

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

Reason # of FDA Reports
1Product used for unknown indication896
2Benign prostatic hyperplasia*807
3Bladder disorder251
4Prostatomegaly*242
5Dysuria199
6Prostatic disorder104
7Pollakiuria80
8Urinary retention63
9Bladder obstruction62
10Urinary incontinence42

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


Types of Adverse Events for RAPAFLO

Total Reports Filed with FDA: 4446


Number of FDA Adverse Event Reports by Patient Age for RAPAFLO

Total Reports Filed with FDA: 4446*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Silodosin (Rapaflo)

Charts are based on 4446 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 RAPAFLO 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.