Medication side effect

Can Acoltremon cause eye irritation?

TRPM8 Thermoreceptor Agonist [EPC]

Yes — eye irritation has been reported as a side effect of Acoltremon in FDA adverse-event reports (FAERS) and product labeling. It is among the more frequently reported events for this medication. These are voluntary reports, so they show what's been reported, not how often it happens.

Reported adverse reactions

ADVERSE REACTIONS The most common adverse reaction was instillation site pain (50%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9780, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%). Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.

Warnings

WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR.

Frequently asked questions

Is eye irritation a side effect of Acoltremon?

Yes — eye irritation has been reported as a side effect of Acoltremon in FDA adverse-event reports (FAERS) and/or its labeling. These are voluntary reports, so they show what's been reported, not how often it happens.

How common is eye irritation with Acoltremon?

eye irritation is among the more frequently reported events for Acoltremon in FAERS. Reporting volume isn't a true incidence rate — check the prescribing information for documented frequencies.

What should I do if I have eye irritation while taking Acoltremon?

Don't stop a prescribed medication on your own. Tell your prescriber or pharmacist — they can tell you whether it's expected, whether it needs attention, and what to do next.

Informational only, drawn from FDA adverse-event reporting (FAERS) and labeling — not medical advice, and not proof a medication caused an effect. Talk to your clinician or pharmacist about any side effect.

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