Drug · FAERS side-effect profile with label screen

Pilocarpine Ophthalmic side effects: what 1,153 FDA adverse event reports show

Pilocarpine Hydrochloride Ophthalmic Solution · 61 reaction terms · 1,007 drug–reaction co-reports · data 2026-09-14

Drug class

Muscarinic cholinergic agonist

FDA label, Indications wording of the closest related product

Label matched

Pilocarpine Hydrochloride Ophthalmic Solution (Pilocarpine Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,153 reports · 55% serious · 32 with death outcome · 81% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pilocarpine hydrochloride ophthalmic solution, is indicated for the: Pilocarpine hydrochloride ophthalmic solution, USP is a muscarinic cholinergic agonist indicated for The reduction of elevated intraocular pressure (IOP) in patients with open-angle g.

FDA label, Indications and Usage

What it is

Pilocarpine hydrochloride ophthalmic solution is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Molecular Structure Established name: pilocarpine hydrochloride

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 35 strongest signals

Labeled adverse reaction 2Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 28

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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. 26 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Intraocular pressure increased (raised eye pressure)	23	32.6 21.7–48.8ROR 33.2 · χ² 672 / p 2e-148	31.8 EB05 22.3 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 39.7	no trial data cached
Sputum discoloured	16	30.8 18.9–50.1ROR 31.2 · χ² 431 / p 5e-96	29.8 EB05 19.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 42.4	no trial data cached
Eye pain	87	28.6 23.4–35.1ROR 30.9 · χ² 2,296 / p <1e-300	28.4 EB05 23.8 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.8 · 85% consumer	no trial data cached
Limb injury	38	25.5 18.7–34.9ROR 26.3 · χ² 870 / p 2e-191	25.2 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.8	no trial data cached
Glaucoma	27	25.5 17.5–37.0ROR 26.1 · χ² 610 / p 5e-135	25.0 EB05 18.1 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.8	no trial data cached
Platelet count increased	18	25.0 15.8–39.6ROR 25.4 · χ² 392 / p 2e-87	24.4 EB05 16.3 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 34.8	no trial data cached
Vasculitis	16	24.9 15.3–40.6ROR 25.3 · χ² 344 / p 4e-77	24.2 EB05 15.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 28.3	no trial data cached
Ocular discomfort	13	21.8 12.7–37.4ROR 22.0 · χ² 237 / p 9e-54	21.0 EB05 12.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pulmonary congestion	15	20.6 12.5–34.1ROR 20.8 · χ² 260 / p 8e-59	20.0 EB05 12.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 25.2	no trial data cached
Wound	31	20.3 14.3–28.7ROR 20.8 · χ² 549 / p 1e-121	20.0 EB05 14.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 24.6 · 90% clinician	no trial data cached
Haematocrit decreased	20	18.2 11.8–28.1ROR 18.5 · χ² 308 / p 3e-69	17.8 EB05 11.9 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 21.6 · 90% clinician	no trial data cached
Choking	18	16.8 10.6–26.6ROR 17.1 · χ² 253 / p 4e-57	16.3 EB05 10.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.7	no trial data cached
Transient ischaemic attack (mini-stroke)	31	16.6 11.7–23.5ROR 17.1 · χ² 440 / p 6e-98	16.4 EB05 11.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Seasonal allergy	11	14.2 7.9–25.5ROR 14.3 · χ² 122 / p 1e-28	12.6 EB05 6.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Musculoskeletal chest pain	12	14.1 8.0–24.7ROR 14.2 · χ² 133 / p 5e-31	12.7 EB05 6.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 21.1	no trial data cached
Photophobia (light sensitivity)	14	13.6 8.1–22.9ROR 13.8 · χ² 151 / p 4e-35	12.5 EB05 7.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Eye irritation	40	13.0 9.6–17.7ROR 13.5 · χ² 433 / p 2e-96	12.7 EB05 9.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.8	no trial data cached
Kidney infection	14	13.0 7.7–21.8ROR 13.1 · χ² 143 / p 3e-33	11.7 EB05 6.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Productive cough (cough with phlegm)	32	12.3 8.7–17.3ROR 12.6 · χ² 321 / p 5e-72	11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Sinus disorder	13	11.9 6.9–20.4ROR 12.0 · χ² 119 / p 5e-28	10.4 EB05 5.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial data cached
Infusion related reaction (reaction during infusion)	42	11.6 8.6–15.5ROR 11.9 · χ² 395 / p 3e-88	11.2 EB05 8.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Dry eye	29	10.9 7.6–15.6ROR 11.1 · χ² 251 / p 1e-56	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.0	no trial data cached
Coronary artery disease	17	10.1 6.3–16.2ROR 10.3 · χ² 131 / p 1e-30	8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Dry mouth	44	9.9 7.4–13.2ROR 10.2 · χ² 343 / p 7e-77	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Urinary retention	18	9.8 6.2–15.5ROR 10.0 · χ² 134 / p 3e-31	8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Acute myocardial infarction	16	9.8 6.0–16.0ROR 9.9 · χ² 118 / p 8e-28	8.5 EB05 5.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Pneumonitis	14	9.4 5.6–15.8ROR 9.5 · χ² 97 / p 3e-23	7.9 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Ocular hyperaemia	22	8.6 5.7–12.9ROR 8.7 · χ² 140 / p 2e-32	7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.4 · 81% consumer	no trial data cached
Skin disorder	15	8.2 5.0–13.5ROR 8.3 · χ² 88 / p 4e-21	6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.9	no trial data cached
Lacrimation increased	13	7.9 4.6–13.6ROR 8.0 · χ² 72 / p 1e-17	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Cardiac failure congestive	34	7.6 5.5–10.6ROR 7.8 · χ² 189 / p 2e-43	7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Therapeutic product effect decreased	18	7.4 4.7–11.6ROR 7.5 · χ² 93 / p 3e-22	6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Arthropathy	21	6.8 4.5–10.4ROR 6.9 · χ² 99 / p 1e-23	6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Hot flush (hot flashes)	27	6.5 4.5–9.4ROR 6.6 · χ² 121 / p 2e-28	5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.8	no trial data cached
Haemorrhage	36	6.3 4.5–8.6ROR 6.4 · χ² 154 / p 1e-35	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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 pain	87	28.6 23.4–35.1ROR 30.9 · χ² 2,296 / p <1e-300	28.4 EB05 23.8 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.8 · 85% consumer	no trial data cached
Dry mouth	44	9.9 7.4–13.2ROR 10.2 · χ² 343 / p 7e-77	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Infusion related reaction (reaction during infusion)	42	11.6 8.6–15.5ROR 11.9 · χ² 395 / p 3e-88	11.2 EB05 8.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Eye irritation	40	13.0 9.6–17.7ROR 13.5 · χ² 433 / p 2e-96	12.7 EB05 9.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.8	no trial data cached
Limb injury	38	25.5 18.7–34.9ROR 26.3 · χ² 870 / p 2e-191	25.2 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.8	no trial data cached
Haemorrhage	36	6.3 4.5–8.6ROR 6.4 · χ² 154 / p 1e-35	5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Cardiac failure congestive	34	7.6 5.5–10.6ROR 7.8 · χ² 189 / p 2e-43	7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Productive cough (cough with phlegm)	32	12.3 8.7–17.3ROR 12.6 · χ² 321 / p 5e-72	11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial data cached
Transient ischaemic attack (mini-stroke)	31	16.6 11.7–23.5ROR 17.1 · χ² 440 / p 6e-98	16.4 EB05 11.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Wound	31	20.3 14.3–28.7ROR 20.8 · χ² 549 / p 1e-121	20.0 EB05 14.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 24.6 · 90% clinician	no trial data cached
Dry eye	29	10.9 7.6–15.6ROR 11.1 · χ² 251 / p 1e-56	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.0	no trial data cached
Hot flush (hot flashes)	27	6.5 4.5–9.4ROR 6.6 · χ² 121 / p 2e-28	5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.8	no trial data cached
Glaucoma	27	25.5 17.5–37.0ROR 26.1 · χ² 610 / p 5e-135	25.0 EB05 18.1 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 27.8	no trial data cached
Intraocular pressure increased (raised eye pressure)	23	32.6 21.7–48.8ROR 33.2 · χ² 672 / p 2e-148	31.8 EB05 22.3 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 39.7	no trial data cached
Ocular hyperaemia	22	8.6 5.7–12.9ROR 8.7 · χ² 140 / p 2e-32	7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.4 · 81% consumer	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.

Limb injury — n=38, PRR 25.5
Wound — n=31, PRR 20.3
Transient ischaemic attack — n=31, PRR 16.6
Productive cough — n=32, PRR 12.3
Infusion related reaction — n=42, PRR 11.6
Dry eye — n=29, PRR 10.9
Dry mouth — n=44, PRR 9.9
Ocular hyperaemia — n=22, PRR 8.6
Cardiac failure congestive — n=34, PRR 7.6
Arthropathy — n=21, PRR 6.8

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 Pilocarpine Ophthalmic?

In FDA FAERS, the most frequently co-reported reaction terms for Pilocarpine Ophthalmic are eye pain, dry mouth, infusion related reaction, eye irritation, limb injury, haemorrhage. 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 Pilocarpine Ophthalmic have an FDA boxed warning?

No. The FDA label retrieved for Pilocarpine Ophthalmic has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pilocarpine Ophthalmic 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 84428e9a-f486-44d9-ad93-4ea9069a6787, effective 20251222; matched on openfda.generic_name.exact:"PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION")
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, field patient.drug.openfda.generic_name.exact, 61 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.