What the label lists and what reports show
Vardenafil side effects
Vardenafil's FDA label: “Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.” FAERS holds 669 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (29 reports).
- Generic listed
Check it at the source: the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
Table 1: Adverse Reactions Reported By ≥2% of Patients Treated with Vardenafil and More Frequent on Drug than Placebo in Fixed and Flexible a Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil
| Reaction | Adverse Reaction Placebo N = 1,199 | Percentage of Patients Reporting Reactions Vardenafil N = 2,203 |
|---|---|---|
| Headache | 4% | 15% |
| Flushing | 1% | 11% |
| Rhinitis | 3% | 9% |
| Dyspepsia | 1% | 4% |
| Accidental Injury b | 2% | 3% |
| Sinusitis | 1% | 3% |
| Flu Syndrome | 2% | 3% |
| Dizziness | 1% | 2% |
| Increased Creatine Kinase | 1% | 2% |
| Nausea | 1% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of vardenafil are discussed elsewhere in the labeling: Cardiovascular Effects [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )] Priapism [see Warnings and Precautions ( 5.3 )] Effects on Eye [see Warnings and Precautions ( 5.4 )] Sudden Hearing Loss [see Warnings and Precautions ( 5.5 )] QT Prolongation [see Warnings and Precautions ( 5.7 )] 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Vardenafil was administered to over 4,430 men (mean age 56, range 18 to 89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2,200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year. …
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective January 5, 2026 (SPL set 5876e062-e604-42a7-99c3-5da30b8dac06), via openFDA; the full label on DailyMed
What do FAERS reports show?
669 reports list vardenafil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 243 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vardenafil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions