Acoltremon side effects: what 4,321 FDA adverse event reports show
Drug class
TRPM8 Thermoreceptor Agonist
Brand names
Tryptyr
Who reports
4,321 reports · 2% serious · 9 with death outcome · 88% female
Used for
TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
What it is
TRYPTYR (acoltremon ophthalmic solution) 0.003% contains an agonist of TRPM8 ion channels. Acoltremon’s chemical name is (1 R ,2 S ,5 R )-2-isopropyl- N -(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide.
Boxed warning
None in the current label
Causality screen of the 27 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 8 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye irritation | 2,316 | 210.2 204.1–216.4ROR 451.2 · χ² 462,855 / p <1e-300 | 201.0 EB05 194.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 211.6 | no trial data cached |
| Ocular discomfort | 189 | 85.8 74.6–98.8ROR 89.7 · χ² 15,494 / p <1e-300 | 83.7 EB05 74.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Eye pain | 765 | 68.1 63.8–72.6ROR 82.5 · χ² 49,920 / p <1e-300 | 67.0 EB05 63.1 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 46.9 | no trial data cached |
| Ocular hyperaemia | 323 | 33.7 30.4–37.5ROR 36.4 · χ² 10,180 / p <1e-300 | 33.5 EB05 30.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Dry eye | 324 | 32.6 29.4–36.2ROR 35.2 · χ² 9,857 / p <1e-300 | 32.4 EB05 29.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 56.1 | no trial data cached |
| Lacrimation increased | 182 | 29.7 25.8–34.3ROR 31.0 · χ² 4,995 / p <1e-300 | 29.4 EB05 26.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 | no trial data cached |
| Eye discharge | 50 | 23.8 18.1–31.4ROR 24.1 · χ² 1,066 / p 4e-234 | 23.5 EB05 18.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Eye pruritus | 146 | 21.6 18.4–25.3ROR 22.3 · χ² 2,833 / p <1e-300 | 21.4 EB05 18.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Eye inflammation | 28 | 14.4 10.0–20.9ROR 14.5 · χ² 336 / p 3e-75 | 14.0 EB05 9.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Vision blurred (blurred vision) | 345 | 12.3 11.1–13.6ROR 13.2 · χ² 3,574 / p <1e-300 | 12.2 EB05 11.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 | no trial data cached |
| Photophobia (light sensitivity) | 42 | 10.9 8.1–14.8ROR 11.0 · χ² 368 / p 2e-82 | 10.5 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Eye swelling | 79 | 10.4 8.3–12.9ROR 10.6 · χ² 660 / p 8e-146 | 10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Adverse reaction | 25 | 9.1 6.2–13.5ROR 9.2 · χ² 173 / p 8e-40 | 8.3 EB05 5.7 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Vitreous floaters | 13 | 6.5 3.8–11.2ROR 6.5 · χ² 55 / p 7e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Drug effect less than expected | 14 | 4.8 2.9–8.1ROR 4.8 · χ² 39 / p 3e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Eye infection | 11 | 4.8 2.6–8.6ROR 4.8 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Eye haemorrhage | 13 | 4.7 2.7–8.1ROR 4.7 · χ² 34 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.1 | no trial data cached |
| Rhinorrhoea (runny nose) | 53 | 4.0 3.1–5.2ROR 4.0 · χ² 116 / p 2e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 10 | 3.8 2.0–7.0ROR 3.8 · χ² 18 / p 1e-5 | 3.3 EB05 2.0 · IC025 +0.7 | Lab value / disease marker | serious PRR 14.3 | no trial data cached |
| Burning sensation | 51 | 3.5 2.7–4.6ROR 3.6 · χ² 90 / p 1e-21 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 71% consumer | no trial data cached |
| Product use complaint | 11 | 3.4 1.9–6.2ROR 3.4 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Reporting / coding artifact | serious n=1 | no trial data cached |
| Visual impairment | 83 | 3.3 2.6–4.0ROR 3.3 · χ² 129 / p 3e-30 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Eye disorder | 22 | 3.3 2.1–4.9ROR 3.3 · χ² 32 / p 7e-9 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Drug ineffective (drug did not work) | 879 | 3.2 3.1–3.4ROR 3.8 · χ² 1,447 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Conjunctivitis | 12 | 3.2 1.8–5.6ROR 3.2 · χ² 16 / p 4e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Condition aggravated | 164 | 2.6 2.3–3.1ROR 2.7 · χ² 167 / p 2e-38 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Sneezing | 10 | 2.2 1.2–4.0ROR 2.2 · χ² 5 / p 0.011 | 2.1 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Eye irritation | 2,316 | 210.2 204.1–216.4ROR 451.2 · χ² 462,855 / p <1e-300 | 201.0 EB05 194.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 211.6 | no trial data cached |
| Drug ineffective (drug did not work) | 879 | 3.2 3.1–3.4ROR 3.8 · χ² 1,447 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Eye pain | 765 | 68.1 63.8–72.6ROR 82.5 · χ² 49,920 / p <1e-300 | 67.0 EB05 63.1 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 46.9 | no trial data cached |
| Vision blurred (blurred vision) | 345 | 12.3 11.1–13.6ROR 13.2 · χ² 3,574 / p <1e-300 | 12.2 EB05 11.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 | no trial data cached |
| Dry eye | 324 | 32.6 29.4–36.2ROR 35.2 · χ² 9,857 / p <1e-300 | 32.4 EB05 29.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 56.1 | no trial data cached |
| Ocular hyperaemia | 323 | 33.7 30.4–37.5ROR 36.4 · χ² 10,180 / p <1e-300 | 33.5 EB05 30.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Ocular discomfort | 189 | 85.8 74.6–98.8ROR 89.7 · χ² 15,494 / p <1e-300 | 83.7 EB05 74.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Lacrimation increased | 182 | 29.7 25.8–34.3ROR 31.0 · χ² 4,995 / p <1e-300 | 29.4 EB05 26.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 | no trial data cached |
| Condition aggravated | 164 | 2.6 2.3–3.1ROR 2.7 · χ² 167 / p 2e-38 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Eye pruritus | 146 | 21.6 18.4–25.3ROR 22.3 · χ² 2,833 / p <1e-300 | 21.4 EB05 18.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Visual impairment | 83 | 3.3 2.6–4.0ROR 3.3 · χ² 129 / p 3e-30 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Eye swelling | 79 | 10.4 8.3–12.9ROR 10.6 · χ² 660 / p 8e-146 | 10.1 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Rhinorrhoea (runny nose) | 53 | 4.0 3.1–5.2ROR 4.0 · χ² 116 / p 2e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Burning sensation | 51 | 3.5 2.7–4.6ROR 3.6 · χ² 90 / p 1e-21 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 71% consumer | no trial data cached |
| Eye discharge | 50 | 23.8 18.1–31.4ROR 24.1 · χ² 1,066 / p 4e-234 | 23.5 EB05 18.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
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.
- Eye irritation — n=2,316, PRR 210.2
- Ocular discomfort — n=189, PRR 85.8
- Ocular hyperaemia — n=323, PRR 33.7
- Lacrimation increased — n=182, PRR 29.7
- Eye discharge — n=50, PRR 23.8
- Eye pruritus — n=146, PRR 21.6
- Eye inflammation — n=28, PRR 14.4
- Vision blurred — n=345, PRR 12.3
- Photophobia — n=42, PRR 10.9
- Eye swelling — n=79, PRR 10.4
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 Acoltremon?
In FDA FAERS, the most frequently co-reported reaction terms for Acoltremon are eye irritation, eye pain, vision blurred, dry eye, ocular hyperaemia, ocular discomfort. 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 Acoltremon have an FDA boxed warning?
No. The FDA label retrieved for Acoltremon has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acoltremon 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 2b7715a1-035c-4002-b582-5238efee5d58, effective 20251218; matched on
openfda.generic_name.exact:"ACOLTREMON") - 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, fieldpatient.drug.openfda.generic_name.exact, 35 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
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.