Viagra: adverse event reports filed with FDA

28,349

reports as suspect product

0.1% of all reports · about 1,260 a year

44

reports, 12 months to June 2026

62 in the 12 months before

46%

marked serious by the reporter

60.1% across the class

4%

record death among outcomes, as reported

1,125 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Viagra reports recording the termmedian drug in phosphodiesterase 5 inhibitor

1. Drug ineffectivethe medicine did not work as expected30.1%8,527
2. Erection increased10.5%2,965
3. Headachehead pain5.1%1,450
4. Malignant melanomamelanoma, a skin cancer4.4%1,237
5. Ejaculation disorder2.9%836
6. Drug effect incomplete2.7%779
7. Flushingsudden reddening or warmth of the skin2.5%700
8. Penis disorder2.4%683
9. Erectile dysfunctiondifficulty getting or keeping an erection2.2%628
10. Deaththe patient died; cause not stated by this term1.9%552
11. Vision blurredblurred vision1.8%502
12. Drug effect decreasedthe medicine had less effect1.8%498
13. Intentional product misusedeliberate use not as intended1.6%462
14. Dizzinesslight-headedness or unsteadiness1.6%453
15. Drug interactionan interaction between medicines1.6%450
16. Optic ischaemic neuropathy1.6%446
17. Malaisegeneral feeling of being unwell1.5%433
18. Blindnessloss of sight1.4%411
19. Penile pain1.4%394
20. Malignant melanoma in situ1.4%386
21. Hypertensionhigh blood pressure1.4%385
22. Nasal congestiona blocked nose1.3%374
23. Prostate cancer1.3%367
24. Cyanopsia1.2%347
25. Cerebrovascular accidentstroke1.1%326
26. Off label useused for a purpose or in a way not on the label1.1%325
27. Suspected counterfeit product1.1%317
28. Incorrect dose administeredthe wrong dose was given1.1%314
29. Myocardial infarctionheart attack1.1%307
30. Feeling abnormalfeeling odd or not right1.1%306

Top 30 of 1,273 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the phosphodiesterase 5 inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 92,849 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 88.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 28,349 reports.

Drugs most often listed in the same reports

Other products listed in reports where Viagra is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the phosphodiesterase 5 inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Viagra as a suspect or interacting product; reports listing it only as a concomitant medication (9,513) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.