Drug Safety Information for STENDRA (Avanafil)

FDA Safety-related Labeling Changes for STENDRA (AVANAFIL) Rx Drug: Safety Information Link

Adverse Drug Reactions for STENDRA* (Avanafil)

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 STENDRA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective143
2Erectile dysfunction19
3Headache10
4Drug effect decreased9
5Flushing7
6Drug effect delayed4
7Dizziness4
8Tinnitus3
9Nausea3
10Feeling hot3
11Back pain2
12Tremor2
13Cough2
14Hypoaesthesia2
15Arthralgia2
16Incorrect dose administered2
17Chest discomfort2
18Malaise2
19Hypoacusis2
20Dyspnoea2

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

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

Reason # of FDA Reports
1Erectile dysfunction210
2Product used for unknown indication64
3Diabetic neuropathy2
4Genital disorder male1
5Sexual dysfunction1

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


Types of Adverse Events for STENDRA

Total Reports Filed with FDA: 308


Number of FDA Adverse Event Reports by Patient Age for STENDRA

Total Reports Filed with FDA: 308*


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

Charts are based on 308 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 STENDRA 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.