Sildenafil citrate: adverse event reports filed with FDA

5,933

reports as suspect product

0% of all reports · about 265 a year

282

reports, 12 months to June 2026

298 in the 12 months before

69.1%

marked serious by the reporter

60.1% across the class

15.5%

record death among outcomes, as reported

921 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 Sildenafil citrate reports recording the termmedian drug in phosphodiesterase 5 inhibitor

1. Drug ineffectivethe medicine did not work as expected18.4%1,090
2. Dyspnoeashortness of breath8.8%520
3. Headachehead pain7.8%464
4. Deaththe patient died; cause not stated by this term6.6%392
5. Hypotensionlow blood pressure4.2%252
6. Dizzinesslight-headedness or unsteadiness4.2%250
7. Nauseafeeling sick3.9%234
8. Diarrhoealoose or frequent stools3.7%221
9. Off label useused for a purpose or in a way not on the label3.6%213
10. Fatiguetiredness3.5%210
11. Pneumonialung infection3.2%189
12. Coughcough3.2%187
13. Condition aggravatedthe condition being treated got worse3.1%183
14. Malaisegeneral feeling of being unwell2.8%165
15. Pulmonary hypertensionhigh pressure in the lung arteries2.4%140
16. Product use issuea problem in how the product was used2.3%135
17. Chest painchest pain2.2%129
18. Vomitingbeing sick2.1%127
19. Fluid retentionthe body holding extra fluid2%121
20. Pyrexiafever2%120
21. Nasal congestiona blocked nose2%116
22. Falla fall1.9%114
23. Oxygen saturation decreased1.9%113
24. Flushingsudden reddening or warmth of the skin1.8%109
25. Dyspnoea exertional1.8%108
26. Painpain, site not specified1.8%108
27. Pain in extremitypain in an arm or leg1.8%108
28. Weight decreasedweight loss1.8%105
29. Oedema peripheralswelling of the legs, ankles or hands1.7%102
30. Chest discomfortchest discomfort1.7%101

Top 30 of 863 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. 63.2% 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 5,933 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sildenafil citrate 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 Sildenafil citrate as a suspect or interacting product; reports listing it only as a concomitant medication (16,588) 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.