OpenClaim

Vardenafil Side Effects

The most commonly reported side effects of vardenafil include erectile dysfunction, headache, and flushing, based on 8,331 FDA adverse event reports from 2004 to 2025. 9.8% of reports found the drug to be ineffective.

Vardenafil side effects

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

1
Erectile Dysfunction16.9%1,411
2
Drug Ineffective9.8%813
3
Drug Ineffective7.3%605
4
Headache7.0%580
5
Flushing3.3%272
6
Chronic Kidney Disease2.5%208
7
Nasal Congestion2.4%199
8
Dizziness2.4%199
9
Erection Increased2.4%196
10
Malignant Melanoma2.2%182
11
Adverse Event1.9%156
12
Headache1.8%154
13
Renal Failure1.7%145
14
Acute Kidney Injury1.7%143
15
Nausea1.6%134

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

Report severity

38.1%Serious3,172 reports
12.6%Hospitalizations1,047 reports
3.3%Fatal275 reports

Seriousness is determined by the reporter, not by OpenClaim.

Vardenafil drug interactions

Other drugs that appear in adverse event reports alongside vardenafil. 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
Sildenafil-citrate6.7%562
2
Tadalafil5.9%490
3
Omeprazole1.9%161
4
Esomeprazole1.9%156
5
Lenalidomide1.4%120
6
Pantoprazole-sodium1.3%106
7
Testosterone1.0%81
8
Lansoprazole1.0%80
9
Rosiglitazone-maleate0.7%56
10
Tenofovir0.6%54
11
Emtricitabine0.6%51
12
Quetiapine-fumarate0.6%50
13
Metformin0.6%50
14
Exenatide-synthetic0.5%43
15
Aspirin0.4%37

Taken alongside

1
Aspirin11.7%975
2
Lisinopril9.5%793
3
Sildenafil-citrate8.6%719
4
Simvastatin7.9%654
5
Metformin7.4%617
6
Atorvastatin-calcium7.3%612
7
Acetaminophen6.7%560
8
Hydrochlorothiazide6.4%536
9
Amlodipine6.2%516
10
Omeprazole5.7%479
11
Metoprolol5.5%458
12
Albuterol4.6%380
13
Ergocalciferol4.4%364
14
Insulin4.1%344
15
Tamsulosin-hydrochloride4.1%343

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 vardenafil side effects

1.3% of vardenafil adverse event reports involve female patients and 95.2% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female1.3%
Male95.2%
Unknown3.4%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6458.0%
65+41.9%

What is vardenafil used for

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

Accidental ExposureAdjuvant TherapyAdverse EventAngina PectorisAnorgasmiaAntidepressant TherapyAphrodisiac TherapyAtrophyAdverse Drug ReactionBack DisorderBack InjuryBack PainBenign Prostatic HyperplasiaBlood Testosterone AbnormalBlood Testosterone Decreased

Showing 15 of 125 indications

Vardenafil brand names and reporting trend

Vardenafil is sold under the brand name Vardenafil Hydrochloride.

Brand names

Vardenafil Hydrochloride6

Quarterly reports (20042025)

20052010201520202025

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

Taking vardenafil with another medication?

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