Arteriolar Vasodilator side effects compared: 3 drugs, 108,417 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Minoxidil | 44,631 | 11% | 449 | boxed | Hair growth abnormal; Hair disorder; Hypertrichosis | Application site pruritus; Application site irritation |
| Minoxidil Foam 5% (Womens) (Minoxidil) | 32,791 | 14% | 448 | – | Application site irritation; Application site pain; Hair texture abnormal | Application site pruritus; Application site dryness |
| Biotin | 30,995 | 47% | 966 | – | – | – |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Vascular anastomotic haemorrhage | 2/3 | 873.8 | 32 | 0/2 members' labels |
| Application site acne | 2/3 | 190.2 | 247 | 0/2 members' labels |
| Dandruff | 2/3 | 170.8 | 1,050 | 0/2 members' labels |
| Application site dryness | 2/3 | 162.8 | 1,559 | 0/2 members' labels |
| Application site ulcer | 2/3 | 135.7 | 283 | 0/2 members' labels |
| Perineal cyst | 2/3 | 103.6 | 22 | 0/2 members' labels |
| Vena cava injury | 2/3 | 103.3 | 28 | 0/2 members' labels |
| Hypertrichosis | 2/3 | 102.1 | 581 | 1/2 members' labels |
| Application site papules | 2/3 | 96.4 | 313 | 0/2 members' labels |
| Hair injury | 2/3 | 94.9 | 90 | 0/2 members' labels |
| Application site exfoliation | 2/3 | 88.3 | 1,150 | 0/2 members' labels |
| Application site pruritus | 2/3 | 74.9 | 5,461 | 0/2 members' labels |
| Application site irritation | 2/3 | 65.2 | 2,649 | 1/2 members' labels |
| Application site scab | 2/3 | 63.8 | 454 | 0/2 members' labels |
| Renal cyst haemorrhage | 2/3 | 58.5 | 42 | 0/2 members' labels |
| Hair texture abnormal | 2/3 | 36.4 | 1,779 | 1/2 members' labels |
| Application site paraesthesia | 2/3 | 33.0 | 152 | 0/2 members' labels |
| Application site pain | 2/3 | 32.7 | 2,504 | 1/2 members' labels |
| Hair growth abnormal | 2/3 | 30.8 | 781 | 1/2 members' labels |
| Central serous chorioretinopathy | 2/3 | 30.2 | 64 | 0/2 members' labels |
| Vascular compression | 2/3 | 28.1 | 30 | 0/2 members' labels |
| Trichorrhexis | 2/3 | 27.5 | 277 | 0/2 members' labels |
| Abdominal wall haemorrhage | 2/3 | 27.0 | 24 | 0/2 members' labels |
| Application site inflammation | 2/3 | 26.6 | 128 | 0/2 members' labels |
| Application site pustules | 2/3 | 23.4 | 30 | 0/2 members' labels |
| Application site discomfort | 2/3 | 21.6 | 137 | 0/2 members' labels |
| Mixed anxiety and depressive disorder | 2/3 | 20.9 | 26 | 0/2 members' labels |
| Application site rash | 2/3 | 20.3 | 997 | 0/2 members' labels |
| Application site infection | 2/3 | 19.8 | 36 | 0/2 members' labels |
| Application site hypersensitivity | 2/3 | 19.7 | 88 | 0/2 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.