Vardenafil side effects: what 588 FDA adverse event reports show

Vardenafil · 9 reaction terms · 89 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

588 reports · 82% serious · 51 with death outcome · 1% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Vardenafil hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ).

FDA label, Indications and Usage

What it is

Vardenafil hydrochloride orally disintegrating tablets, USP are an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 7 strongest signals

Labeled (related wording) 1Likely indication confounding 1Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 3

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Malignant melanoma	17	45.2 28.3–72.3ROR 46.6 · χ² 691 / p 1e-152	43.2 EB05 28.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 32.2	no trial data cached
Cholestasis (bile flow blockage)	14	26.2 15.6–43.9ROR 26.8 · χ² 314 / p 1e-70	25.3 EB05 15.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Transaminases increased	12	19.3 11.0–33.7ROR 19.7 · χ² 190 / p 2e-43	18.4 EB05 10.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5	no trial data cached
International normalised ratio increased	12	14.9 8.5–26.0ROR 15.2 · χ² 142 / p 5e-33	13.6 EB05 7.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 10.7	no trial data cached
Poisoning	5	14.1 5.9–33.8ROR 14.2 · χ² 49 / p 2e-12	9.7 EB05 3.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Erectile dysfunction	7	9.7 4.6–20.3ROR 9.8 · χ² 46 / p 5e-12	6.9 EB05 3.3 · IC025 +1.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.8	no trial data cached
Completed suicide (death by suicide)	14	5.9 3.5–10.0ROR 6.1 · χ² 53 / p 2e-13	5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Malignant melanoma	17	45.2 28.3–72.3ROR 46.6 · χ² 691 / p 1e-152	43.2 EB05 28.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 32.2	no trial data cached
Completed suicide (death by suicide)	14	5.9 3.5–10.0ROR 6.1 · χ² 53 / p 2e-13	5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.2	no trial data cached
Cholestasis (bile flow blockage)	14	26.2 15.6–43.9ROR 26.8 · χ² 314 / p 1e-70	25.3 EB05 15.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
International normalised ratio increased	12	14.9 8.5–26.0ROR 15.2 · χ² 142 / p 5e-33	13.6 EB05 7.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 10.7	no trial data cached
Transaminases increased	12	19.3 11.0–33.7ROR 19.7 · χ² 190 / p 2e-43	18.4 EB05 10.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5	no trial data cached
Erectile dysfunction	7	9.7 4.6–20.3ROR 9.8 · χ² 46 / p 5e-12	6.9 EB05 3.3 · IC025 +1.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.8	no trial data cached
Poisoning	5	14.1 5.9–33.8ROR 14.2 · χ² 49 / p 2e-12	9.7 EB05 3.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Sopor	4	10.7 4.0–28.3ROR 10.7 · χ² 26 / p 2e-7	6.2 EB05 2.3 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Poisoning deliberate	4	15.3 5.8–40.7ROR 15.4 · χ² 40 / p 1e-10	9.6 EB05 3.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Vardenafil?

In FDA FAERS, the most frequently co-reported reaction terms for Vardenafil are malignant melanoma, cholestasis, international normalised ratio increased, transaminases increased, erectile dysfunction, poisoning. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Vardenafil have an FDA boxed warning?

No. The FDA label retrieved for Vardenafil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Vardenafil causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0ce4eb7b-fa50-441d-ae71-eb33dca27926, effective 20250730; matched on openfda.generic_name.exact:"VARDENAFIL")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 9 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.