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Sildenafil Side Effects

The most commonly reported side effects of sildenafil include dyspnoea, headache, and death, based on 126,255 FDA adverse event reports from 2004 to 2025. 7.4% of reports found the drug to be ineffective.

Sildenafil side effects

Percentages show how often each reaction appears relative to total reports for sildenafil.

1
Dyspnoea9.6%12,175
2
Drug Ineffective7.4%9,393
3
Headache7.2%9,059
4
Death5.9%7,434
5
Diarrhoea5.2%6,574
6
Nausea4.7%5,940
7
Fatigue4.6%5,798
8
Dizziness4.0%5,102
9
Pneumonia3.5%4,474
10
Cough3.4%4,326
11
Malaise3.3%4,160
12
Off Label Use3.0%3,749
13
Vomiting2.7%3,420
14
Pain2.7%3,371
15
Hypotension2.7%3,346

These are voluntary reports and do not establish that sildenafil caused these reactions.

Report severity

66.9%Serious84,514 reports
35.1%Hospitalizations44,314 reports
14.7%Fatal18,593 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sildenafil drug interactions

Other drugs that appear in adverse event reports alongside sildenafil. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Treprostinil18.5%23,402
2
Ambrisentan12.7%15,980
3
Bosentan7.7%9,729
4
Macitentan6.3%7,991
5
Epoprostenol-sodium3.7%4,617
6
Selexipag2.8%3,569
7
Tadalafil2.1%2,677
8
Iloprost1.8%2,308
9
Lenalidomide0.8%963
10
Omeprazole0.8%948
11
Warfarin0.7%835
12
Furosemide0.7%822
13
Esomeprazole0.6%753
14
Metformin0.6%721
15
Acetaminophen0.6%714

Taken alongside

1
Furosemide11.3%14,293
2
Warfarin10.2%12,903
3
Aspirin8.8%11,070
4
Acetaminophen7.1%8,969
5
Atorvastatin-calcium6.5%8,151
6
Spironolactone6.0%7,554
7
Albuterol5.9%7,490
8
Oxygen5.7%7,221
9
Omeprazole5.7%7,146
10
Amlodipine5.6%7,132
11
Ergocalciferol5.5%6,907
12
Treprostinil5.1%6,402
13
Levothyroxine-sodium4.7%5,925
14
Fluticasone4.6%5,813
15
Macitentan4.6%5,800

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sildenafil side effects

41.5% of sildenafil adverse event reports involve female patients and 50.9% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.5%
Male50.9%
Unknown7.6%

Age group

< 22.2%
2–112.3%
12–171.1%
18–6455.0%
65+39.4%

What is sildenafil used for

Conditions and purposes for which patients were taking sildenafil when the adverse event was reported.

Abdominal PainAbscess LimbAccidental ExposureAcute Kidney InjuryAcute Lymphocytic LeukaemiaAcute Respiratory FailureAcute SinusitisAdjuvant TherapyAdverse Drug ReactionAgitationAlveolar Capillary DysplasiaAmyotrophic Lateral SclerosisAnaemiaAnal CancerAnal Incontinence

Showing 15 of 977 indications

Sildenafil brand names and reporting trend

Sildenafil is sold under the brand name Revatio.

Brand names

Revatio60,000

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sildenafil with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.