Minoxidil Foam 5% (Womens) side effects: what 32,791 FDA adverse event reports show

Minoxidil Foam 5% (Womens) · Minoxidil · 1,044 reaction terms · 62,771 drug–reaction co-reports · data 2026-09-14

Drug class

Arteriolar Vasodilator

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Minoxidil

openFDA label

Who reports

32,791 reports · 14% serious · 448 with death outcome · 23% female

openFDA FAERS counts, all years, deduplication not applied

Used for

to regrow hair on the top of the scalp (see pictures on side of this carton)

FDA label, Indications and Usage

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 40 strongest signals

Labeled (related wording) 3Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 33

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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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.
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. 1,004 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
Vascular anastomotic haemorrhage	16	1,007.8 457.4–2,220.7ROR 1,008.3 · χ² 5,808 / p <1e-300	265.3 EB05 173.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Application site acne	106	182.9 147.4–227.0ROR 183.5 · χ² 14,722 / p <1e-300	138.5 EB05 117.7 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site dryness	738	176.7 163.0–191.6ROR 180.7 · χ² 100,560 / p <1e-300	137.7 EB05 129.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Dandruff	472	174.4 157.6–193.0ROR 176.9 · χ² 63,594 / p <1e-300	136.0 EB05 126.0 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=8 · 100% consumer	no trial arm names this drug
Application site ulcer	131	144.0 119.1–174.1ROR 144.6 · χ² 15,026 / p <1e-300	115.5 EB05 99.8 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=5 · 98% consumer	no trial arm names this drug
Perineal cyst	11	119.5 62.7–227.6ROR 119.5 · χ² 989 / p 3e-217	86.0 EB05 51.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Vena cava injury	14	119.2 67.3–211.0ROR 119.2 · χ² 1,282 / p 5e-281	88.6 EB05 56.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Hypertrichosis	286	115.9 102.2–131.4ROR 116.9 · χ² 27,426 / p <1e-300	97.4 EB05 88.3 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=107 · ♀ 69% (drug 23%)	no trial arm names this drug
Application site papules	154	109.4 92.2–129.7ROR 109.9 · χ² 13,997 / p <1e-300	92.3 EB05 80.7 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site exfoliation	535	94.8 86.6–103.7ROR 96.3 · χ² 43,083 / p <1e-300	82.3 EB05 76.6 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site pruritus	2,535	80.4 77.2–83.7ROR 87.0 · χ² 176,359 / p <1e-300	71.4 EB05 69.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=16 · 100% consumer	no trial arm names this drug
Application site irritation	1,229	70.0 66.1–74.2ROR 72.7 · χ² 75,257 / p <1e-300	63.1 EB05 60.2 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=5 · 100% consumer	no trial arm names this drug
Application site scab	210	68.3 59.3–78.7ROR 68.7 · χ² 12,503 / p <1e-300	61.4 EB05 54.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=5 · 99% consumer	no trial arm names this drug
Adverse drug reaction	8,573	67.7 66.4–69.1ROR 91.4 · χ² 511,122 / p <1e-300	61.3 EB05 60.2 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · ♀ 0% (drug 23%) · 100% consumer	no trial arm names this drug
Renal cyst haemorrhage	21	67.5 43.0–105.8ROR 67.5 · χ² 1,183 / p 1e-259	58.0 EB05 40.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 0% (drug 23%)	no trial arm names this drug
Hair injury	25	58.5 38.9–88.2ROR 58.6 · χ² 1,242 / p 3e-272	51.7 EB05 36.8 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Central serous chorioretinopathy	32	34.9 24.4–49.8ROR 34.9 · χ² 966 / p 2e-212	32.5 EB05 24.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 50% (drug 23%) · 100% clinician	no trial arm names this drug
Application site pain	1,091	33.3 31.4–35.4ROR 34.4 · χ² 32,468 / p <1e-300	31.7 EB05 30.1 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=11 · 99% consumer	no trial arm names this drug
Vascular compression	15	32.4 19.3–54.4ROR 32.4 · χ² 404 / p 3e-90	29.8 EB05 19.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Abdominal wall haemorrhage	12	31.1 17.4–55.5ROR 31.1 · χ² 305 / p 1e-68	28.5 EB05 17.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Application site paraesthesia	59	30.1 23.2–39.1ROR 30.2 · χ² 1,557 / p <1e-300	28.6 EB05 22.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	♀ 58% (drug 23%) · 100% consumer	no trial arm names this drug
Application site inflammation	56	27.2 20.8–35.5ROR 27.2 · χ² 1,329 / p 3e-291	25.9 EB05 20.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site pustules	14	25.3 14.9–43.2ROR 25.4 · χ² 292 / p 1e-65	23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Blood 25-hydroxycholecalciferol decreased	11	25.0 13.7–45.7ROR 25.0 · χ² 221 / p 2e-50	23.1 EB05 13.4 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious n=11	no trial arm names this drug
Mixed anxiety and depressive disorder	13	24.2 13.9–42.0ROR 24.2 · χ² 256 / p 6e-58	22.5 EB05 13.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Application site discomfort	64	23.5 18.3–30.1ROR 23.5 · χ² 1,307 / p 2e-286	22.6 EB05 18.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Product administered at inappropriate site	640	23.3 21.6–25.2ROR 23.8 · χ² 13,178 / p <1e-300	22.5 EB05 21.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=11 · ♀ 56% (drug 23%) · 99% consumer	no trial arm names this drug
Intraductal papillary mucinous neoplasm	10	22.7 12.1–42.6ROR 22.7 · χ² 179 / p 3e-41	20.7 EB05 11.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Application site infection	16	20.6 12.5–33.8ROR 20.6 · χ² 270 / p 6e-61	19.4 EB05 12.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=6	no trial arm names this drug
Application site discharge	36	20.5 14.7–28.5ROR 20.5 · χ² 627 / p 1e-138	19.7 EB05 14.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site rash	424	20.2 18.4–22.3ROR 20.5 · χ² 7,500 / p <1e-300	19.6 EB05 18.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	99% consumer	no trial arm names this drug
Hyperparathyroidism secondary	71	18.4 14.6–23.3ROR 18.5 · χ² 1,120 / p 9e-246	17.8 EB05 14.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=71	no trial arm names this drug
Hair texture abnormal	370	18.0 16.2–20.0ROR 18.2 · χ² 5,764 / p <1e-300	17.5 EB05 16.1 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=10 · ♀ 63% (drug 23%) · 99% consumer	no trial arm names this drug
Exposure via eye contact	11	17.9 9.8–32.6ROR 17.9 · χ² 155 / p 8e-36	16.3 EB05 8.7 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Skin fibrosis	13	17.7 10.2–30.7ROR 17.7 · χ² 183 / p 5e-42	16.3 EB05 9.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Delayed graft function	19	17.6 11.2–27.8ROR 17.6 · χ² 274 / p 8e-62	16.7 EB05 11.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Application site erythema	591	14.7 13.5–15.9ROR 14.9 · χ² 7,351 / p <1e-300	14.3 EB05 13.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=6 · 99% consumer	no trial arm names this drug
Penile size reduced	21	14.3 9.3–22.0ROR 14.3 · χ² 241 / p 1e-54	13.4 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=20 · 85% consumer	no trial arm names this drug
Application site hypersensitivity	26	14.1 9.5–20.7ROR 14.1 · χ² 296 / p 1e-66	13.3 EB05 9.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	23	13.9 9.2–21.1ROR 14.0 · χ² 258 / p 3e-58	13.1 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=23	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Minoxidil Foam 5% (Womens) (searched MINOXIDIL FOAM 5% (WOMENS).

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
Adverse drug reaction	8,573	67.7 66.4–69.1ROR 91.4 · χ² 511,122 / p <1e-300	61.3 EB05 60.2 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · ♀ 0% (drug 23%) · 100% consumer	no trial arm names this drug
Drug ineffective (drug did not work)	6,221	3.0 3.0–3.1ROR 3.5 · χ² 8,985 / p <1e-300	3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.1 · 96% consumer	no trial arm names this drug
Application site pruritus	2,535	80.4 77.2–83.7ROR 87.0 · χ² 176,359 / p <1e-300	71.4 EB05 69.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=16 · 100% consumer	no trial arm names this drug
Off label use (used outside approved label)	1,449	1.1 1.0–1.1ROR 1.1 · χ² 6 / p 0.006	1.1 EB05 1.0 · IC025 +0.0	Reporting / coding artifact	serious PRR 1.1 · ♀ 85% (drug 23%) · 86% consumer	no trial arm names this drug
Application site irritation	1,229	70.0 66.1–74.2ROR 72.7 · χ² 75,257 / p <1e-300	63.1 EB05 60.2 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=5 · 100% consumer	no trial arm names this drug
Application site pain	1,091	33.3 31.4–35.4ROR 34.4 · χ² 32,468 / p <1e-300	31.7 EB05 30.1 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=11 · 99% consumer	no trial arm names this drug
Headache	1,080	1.1 1.0–1.2ROR 1.1 · χ² 11 / p 6e-4	1.1 EB05 1.0 · IC025 +0.0	Not in label — unassessed	serious PRR 1.9 · 87% consumer	no trial arm names this drug
Alopecia (hair loss)	884	2.9 2.7–3.1ROR 2.9 · χ² 1,089 / p 4e-239	2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.0 · ♀ 60% (drug 23%) · 93% consumer	no trial arm names this drug
Inappropriate schedule of product administration	755	2.7 2.6–2.9ROR 2.8 · χ² 834 / p 9e-184	2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · ♀ 49% (drug 23%) · 97% consumer	no trial arm names this drug
Application site dryness	738	176.7 163.0–191.6ROR 180.7 · χ² 100,560 / p <1e-300	137.7 EB05 129.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Condition aggravated	706	1.5 1.4–1.6ROR 1.5 · χ² 117 / p 1e-27	1.5 EB05 1.4 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.5 · ♀ 59% (drug 23%) · 87% consumer	no trial arm names this drug
Rash	653	1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.169	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.0 · 88% consumer	no trial arm names this drug
Product administered at inappropriate site	640	23.3 21.6–25.2ROR 23.8 · χ² 13,178 / p <1e-300	22.5 EB05 21.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=11 · ♀ 56% (drug 23%) · 99% consumer	no trial arm names this drug
Dizziness	627	0.8 0.7–0.9ROR 0.8 · χ² 30 / p 2e-8	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.9 · 82% consumer	no trial arm names this drug
Hypersensitivity (allergic reaction)	599	2.1 1.9–2.2ROR 2.1 · χ² 332 / p 2e-74	2.1 EB05 1.9 · IC025 +0.9	Not in label — unassessed	serious PRR 1.8 · 95% consumer	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Application site acne — n=106, PRR 182.9
Application site dryness — n=738, PRR 176.7
Dandruff — n=472, PRR 174.4
Application site ulcer — n=131, PRR 144.0
Hypertrichosis — n=286, PRR 115.9
Application site papules — n=154, PRR 109.4
Application site exfoliation — n=535, PRR 94.8
Application site pruritus — n=2,535, PRR 80.4
Application site scab — n=210, PRR 68.3
Renal cyst haemorrhage — n=21, PRR 67.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.

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 Minoxidil Foam 5% (Womens)?

In FDA FAERS, the most frequently co-reported reaction terms for Minoxidil Foam 5% (Womens) are application site pruritus, application site irritation, application site pain, headache, alopecia, application site dryness. 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 Minoxidil Foam 5% (Womens) have an FDA boxed warning?

No. The FDA label retrieved for Minoxidil Foam 5% (Womens) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Minoxidil Foam 5% (Womens) 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 1b54eca8-4a96-1b5e-e063-6394a90a7b94, effective 20260508; matched on openfda.generic_name.exact:"MINOXIDIL FOAM 5% (WOMENS)")
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, 1,044 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
ClinicalTrials.gov API v2 (query MINOXIDIL FOAM 5% (WOMENS, results-bearing studies sorted by enrollment)

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.