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Drug class · FAERS comparison

Arteriolar Vasodilator side effects compared: 3 drugs, 108,417 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Minoxidil44,63111%449boxedHair growth abnormal; Hair disorder; HypertrichosisApplication site pruritus; Application site irritation
Minoxidil Foam 5% (Womens) (Minoxidil)32,79114%448–Application site irritation; Application site pain; Hair texture abnormalApplication site pruritus; Application site dryness
Biotin30,99547%966–––

Class-wide signals (flagged in at least 2 of 3 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Vascular anastomotic haemorrhage2/3873.8320/2 members' labels
Application site acne2/3190.22470/2 members' labels
Dandruff2/3170.81,0500/2 members' labels
Application site dryness2/3162.81,5590/2 members' labels
Application site ulcer2/3135.72830/2 members' labels
Perineal cyst2/3103.6220/2 members' labels
Vena cava injury2/3103.3280/2 members' labels
Hypertrichosis2/3102.15811/2 members' labels
Application site papules2/396.43130/2 members' labels
Hair injury2/394.9900/2 members' labels
Application site exfoliation2/388.31,1500/2 members' labels
Application site pruritus2/374.95,4610/2 members' labels
Application site irritation2/365.22,6491/2 members' labels
Application site scab2/363.84540/2 members' labels
Renal cyst haemorrhage2/358.5420/2 members' labels
Hair texture abnormal2/336.41,7791/2 members' labels
Application site paraesthesia2/333.01520/2 members' labels
Application site pain2/332.72,5041/2 members' labels
Hair growth abnormal2/330.87811/2 members' labels
Central serous chorioretinopathy2/330.2640/2 members' labels
Vascular compression2/328.1300/2 members' labels
Trichorrhexis2/327.52770/2 members' labels
Abdominal wall haemorrhage2/327.0240/2 members' labels
Application site inflammation2/326.61280/2 members' labels
Application site pustules2/323.4300/2 members' labels
Application site discomfort2/321.61370/2 members' labels
Mixed anxiety and depressive disorder2/320.9260/2 members' labels
Application site rash2/320.39970/2 members' labels
Application site infection2/319.8360/2 members' labels
Application site hypersensitivity2/319.7880/2 members' labels

Member-specific signals (flagged in exactly one drug)

No strong single-member signals (n ≥ 50) in this class.

Common questions

Which arteriolar vasodilator has the most FDA adverse event reports?

Minoxidil has the most FAERS co-reports in this class (44,631), followed by Minoxidil Foam 5% (Womens) (32,791). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across arteriolar vasodilator drugs?

Reaction terms flagged in at least half of the 3 members include vascular anastomotic haemorrhage, application site acne, dandruff, application site dryness, application site ulcer. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.