Drug Safety Information for STAXYN (Vardenafil hydrochloride)

Safety-related Labeling Changes for LEVITRA (VARDENAFIL HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for STAXYN (VARDENAFIL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for STAXYN* (Vardenafil 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 STAXYN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Erectile dysfunction1593
2Drug ineffective*1192
3Headache*698
4Flushing*329
5Dizziness253
6Nasal congestion*230
7Erection increased214
8Nausea168
9Adverse event159
10Vision blurred*139
11Diarrhoea119
12Visual impairment117
13Chest pain114
14Drug effect decreased113
15Fatigue*106
16Dyspepsia105
17Dyspnoea105
18Hypotension91
19Feeling abnormal91
20Myocardial infarction90

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

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

Reason # of FDA Reports
1Erectile dysfunction*7005
2Product used for unknown indication1739
3Sexual dysfunction131
4Ill-defined disorder118
5Organic erectile dysfunction37
6Libido decreased25
7Prostatomegaly23
8Unevaluable event22
9Prostatectomy20
10Premature ejaculation17

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


Types of Adverse Events for STAXYN

Total Reports Filed with FDA: 17880


Number of FDA Adverse Event Reports by Patient Age for STAXYN

Total Reports Filed with FDA: 17880*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Vardenafil hydrochloride (Levitra, Vardenafil, Staxyn)

Charts are based on 17880 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 STAXYN 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.