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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.

In bijsluiterNieuw signaalOnbekend & frequent
Symptoom
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
Beoogd effect
56.1 [53.0–59.3]
HAIR Growth Abnormal
Beoogd effect
50.0 [46.1–54.2]
Application SITE PAIN
32.9 [31.2–34.8]
HAIR Colour Changes
Beoogd 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
Beoogd effect
18.9 [16.9–21.2]

ROR = reporting odds ratio (log-schaal). Een waarde boven 1 betekent dat het symptoom vaker wordt gemeld voor dit product dan voor alle andere producten samen. Dit meet hoeveel het opvalt in meldingen — geen causaliteit, geen risico.

INTERPRETATION
Auto-gegenereerd

Minoxidil tiene efectos adversos notificados desproporcionadamente. La "alopecia" (ROR 10.0) es un efecto paradójico, ya que el minoxidil se usa para el crecimiento del cabello. Sin embargo, "hair texture abnormal" (ROR 56.1) es lógico, ya que el minoxidil altera el ciclo capilar. "Application site pruritus" (ROR 74.3) e "irritation" (ROR 62.1) son esperables por su aplicación tópica. "Notificado con frecuencia" no es lo mismo que "causado con frecuencia". Esto no sustituye el consejo médico.

Dit vervangt geen medisch advies.

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
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Reports140,435
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BRON & CITATIE
HealthProves. minoxidil — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/minoxidil/
FAERS44,095 records
Opgehaald2026-07-04
MethodeROR / disproportionaliteit