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REPORTED SIGNALS

minoxidil

Rogaine · Loniten

Registration status unknownDrugglp-1Rite Aid Corporation
TOPICAL

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

44,095
reports (FAERS)
10.3%
reported as serious
307
fatal reports (0.7%)
29
signals above threshold
1979
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
1979
1978
2026
SIGNAL RANKING · ROR

What stands out in the reports.

On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Dandruff
172.3 [156.5–189.6]
Application SITE Dryness
153.8 [142.0–166.6]
Application SITE Exfoliation
82.8 [75.9–90.3]
Application SITE Pruritus
74.3 [71.4–77.3]
Product Formulation Issue
65.7 [60.9–70.8]
Application SITE Irritation
62.1 [58.7–65.7]
Adverse DRUG Reaction
62.0 [60.5–63.5]
HAIR Texture Abnormal
Intended effect
56.1 [53.0–59.3]
HAIR Growth Abnormal
Intended effect
50.0 [46.1–54.2]
Application SITE PAIN
32.9 [31.2–34.8]
HAIR Colour Changes
Intended effect
28.5 [26.4–30.7]
DRUG Administered AT Inappropriate SITE
23.1 [21.1–25.3]
Application SITE RASH
20.5 [18.8–22.3]
Product Administered AT Inappropriate SITE
19.4 [18.0–21.0]
HAIR Disorder
Intended effect
18.9 [16.9–21.2]

ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.

INTERPRETATION
Auto-generated

Minoxidil reports show some effects more often than average. "Application site exfoliation," "pruritus," and "irritation" are frequently reported. This is logical, as topical minoxidil can irritate the skin. "Hair texture abnormal" is also reported more often, which is expected as minoxidil affects hair growth. "Alopecia" is also reported more frequently. While minoxidil treats hair loss, initial shedding can occur. Remember, "frequently reported" is not the same as "frequently caused." This does not replace medical advice.

This does not replace medical advice.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Dandruff
Application SITE Dryness
Application SITE Exfoliation
Application SITE Pruritus
Product Formulation Issue
Application SITE Irritation
Adverse DRUG Reaction
HAIR Texture Abnormal
REPORTS OVER TIME

Report volume per quarter.

19791980198119821984
RECALL HISTORY · 0 ON RECORD

No recalls on record.

COMPARE WITHIN GLP-1
tirzepatide
Mounjaro · Zepbound
Reports140,435
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semaglutide
Ozempic · Wegovy
Reports82,911
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finasteride
Propecia · Proscar
Reports58,942
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SOURCE & CITATION
HealthProves. minoxidil — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/minoxidil/
FAERS44,095 records
Retrieved2026-07-04
MethodROR / disproportionality