OpenClaim

Tadalafil Side Effects

The most commonly reported side effects of tadalafil include dyspnoea, headache, and diarrhoea, based on 96,855 FDA adverse event reports from 2004 to 2025. 4.4% of reports found the drug to be ineffective.

Tadalafil side effects

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

1
Dyspnoea11.9%11,508
2
Headache10.4%10,094
3
Diarrhoea8.0%7,731
4
Nausea6.6%6,387
5
Fatigue5.9%5,714
6
Death5.6%5,417
7
Dizziness5.2%4,999
8
Drug Ineffective4.4%4,275
9
Cough4.3%4,176
10
Pneumonia4.2%4,103
11
Malaise3.8%3,656
12
Vomiting3.5%3,377
13
Asthenia3.3%3,214
14
Pain3.3%3,168
15
Fluid Retention3.2%3,132

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

Report severity

62.3%Serious60,322 reports
37.6%Hospitalizations36,419 reports
11.1%Fatal10,752 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tadalafil drug interactions

Other drugs that appear in adverse event reports alongside tadalafil. 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
Treprostinil25.4%24,612
2
Ambrisentan22.4%21,704
3
Macitentan8.2%7,949
4
Selexipag6.3%6,105
5
Bosentan4.1%4,000
6
Epoprostenol-sodium3.5%3,413
7
Sildenafil-citrate2.3%2,264
8
Sotatercept-csrk0.9%898
9
Lenalidomide0.7%712
10
Relugolix0.7%709
11
Iloprost0.7%707
12
Riociguat0.6%614
13
Warfarin0.6%582
14
Furosemide0.6%576
15
Sodium-oxybate0.5%504

Taken alongside

1
Furosemide10.0%9,643
2
Ambrisentan8.8%8,530
3
Warfarin8.6%8,283
4
Aspirin7.6%7,323
5
Treprostinil7.2%6,992
6
Macitentan6.6%6,414
7
Acetaminophen6.2%5,957
8
Ergocalciferol5.9%5,670
9
Spironolactone5.6%5,393
10
Oxygen5.4%5,274
11
Atorvastatin-calcium5.4%5,272
12
Amlodipine5.2%5,038
13
Omeprazole5.1%4,968
14
Albuterol4.7%4,585
15
Levothyroxine-sodium4.3%4,122

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 tadalafil side effects

50.7% of tadalafil adverse event reports involve female patients and 45.2% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female50.7%
Male45.2%
Unknown4.1%

Age group

< 20.3%
2–111.6%
12–171.6%
18–6455.8%
65+40.6%

What is tadalafil used for

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

Accident At WorkAccidental Drug Intake By ChildAccidental Exposure To Product By ChildAccidental OverdoseAdenoma BenignAdjuvant TherapyAdverse EventAffective DisorderAgitationAlopeciaAnal CancerAnalgesic TherapyAnaphylactic ReactionAndrogen DeficiencyAngina Unstable

Showing 15 of 581 indications

Tadalafil brand names and reporting trend

Tadalafil is sold under the brand name Chewtadzy.

Brand names

Chewtadzy31,477

Quarterly reports (20042025)

20052010201520202025

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

Taking tadalafil with another medication?

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