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REPORTED SIGNALS

bimatoprost

Latisse · Lumigan

Registration status unknownDruginjectablesAurobindo Pharma Limited
OPHTHALMIC

1 INDICATIONS AND USAGE Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )

Mechanism. 12.1 Mechanism of Action Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

28,372
reports (FAERS)
27.1%
reported as serious
613
fatal reports (2.2%)
30
signals above threshold
2001
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
2001
Class III recall
2017
Class III recall
2017
2000
2026
SIGNAL RANKING · ROR

What stands out in the reports.

In bijsluiterNieuw signaalOnbekend & frequent
Symptoom
0.1110100
ROR [95% CI]
Blepharal Pigmentation
904.1 [757.81078.5]
Growth OF Eyelashes
441.6 [381.9510.6]
Erythema OF Eyelid
181.5 [169.3194.6]
Eyelids Pruritus
159.9 [145.4175.7]
Eyelid Irritation
136.8 [122.4152.8]
Madarosis
103.3 [97.5109.4]
Trichorrhexis
83.2 [73.594.2]
Intraocular Pressure Increased
44.8 [41.548.4]
SKIN Hyperpigmentation
44.6 [40.749.0]
Ocular Hyperaemia
42.9 [41.144.8]
EYE Pruritus
33.1 [31.335.0]
Treatment Failure
32.3 [31.133.5]
EYE Irritation
27.8 [26.529.2]
Eyelid Oedema
27.5 [24.930.3]
EYE Discharge
23.1 [20.626.0]

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

Bimatoprost zeigt häufig gemeldete Nebenwirkungen wie Blepharalpigmentierung und Wimpernwachstum (ROR 904.1 bzw. 441.6). Dies ist logisch, da Bimatoprost als Prostaglandin-Analogon das Wimpernwachstum fördert und Pigmentierungen verursachen kann. Auch vermehrter Tränenfluss (ROR 9.6) und Trichorrhexis (ROR 83.2) werden häufig gemeldet. „Häufig gemeldet" bedeutet nicht „häufig verursacht". Dies ersetzt keinen medizinischen Rat.

Dit vervangt geen medisch advies.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Blepharal Pigmentation
Growth OF Eyelashes
Erythema OF Eyelid
Eyelids Pruritus
Eyelid Irritation
Madarosis
Trichorrhexis
Intraocular Pressure Increased
REPORTS OVER TIME

Report volume per quarter.

20012002200320042006
RECALL HISTORY · 2 ON RECORD
DateClassReasonFirm
Oct 19, 2017IIIFailed Impurities/Degradation Specifications.Allergan Sales, LLC
Mar 16, 2017IIIFailed Impurities/Degradation SpecificationsAllergan Sales, LLC

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm. Source: openFDA enforcement.

COMPARE WITHIN INJECTABLES
tretinoin
Retin-A · Atralin
Reports8,579
Compare with bimatoprost
BRON & CITATIE
HealthProves. bimatoprost — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/bimatoprost/
FAERS28,372 records
Opgehaald2026-07-04
MethodeROR / disproportionaliteit