Drug · FAERS side-effect profile with label screen
Pilocarpine side effects: what 2,460 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pilocarpine Hydrochloride (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
2,460 reports · 62% serious · 98 with death outcome · 82% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
FDA label, Indications and Usage
What it is
DESCRIPTION Pilocarpine hydrochloride tablets, USP contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a white or almost white, crystalline powder or colorless crystals, hygroscopic which is very soluble in water and freely soluble in ethanol (96 percent).
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 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 7Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 23
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.
- 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. 174 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vitreous floaters | 69 | 44.7 35.3–56.5ROR 45.6 · χ² 2,884 / p <1e-300 | 43.9 EB05 35.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Retinal detachment | 48 | 32.9 24.8–43.5ROR 33.3 · χ² 1,444 / p <1e-300 | 32.3 EB05 25.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Eye pain | 163 | 18.5 16.0–21.5ROR 19.4 · χ² 2,686 / p <1e-300 | 18.4 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 83% consumer | no trial data cached |
| Ocular discomfort | 30 | 17.3 12.1–24.8ROR 17.5 · χ² 445 / p 5e-99 | 17.1 EB05 12.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Eye irritation | 141 | 15.9 13.5–18.7ROR 16.5 · χ² 1,951 / p <1e-300 | 15.8 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Sputum discoloured | 20 | 13.3 8.6–20.6ROR 13.4 · χ² 215 / p 7e-49 | 12.5 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 26 | 12.7 8.7–18.6ROR 12.8 · χ² 268 / p 1e-60 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 16.5 | no trial data cached |
| Ocular hyperaemia | 93 | 12.5 10.2–15.3ROR 12.8 · χ² 972 / p 1e-213 | 12.3 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 71% consumer | no trial data cached |
| Vasculitis | 23 | 12.4 8.2–18.6ROR 12.5 · χ² 229 / p 5e-52 | 11.7 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · 91% clinician | no trial data cached |
| Photophobia (light sensitivity) | 33 | 11.1 7.9–15.6ROR 11.2 · χ² 293 / p 7e-66 | 10.5 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 80% consumer | no trial data cached |
| Intervertebral disc degeneration | 16 | 10.8 6.6–17.6ROR 10.8 · χ² 132 / p 7e-31 | 9.5 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 | no trial data cached |
| Body temperature decreased | 17 | 10.7 6.7–17.3ROR 10.8 · χ² 140 / p 1e-32 | 9.5 EB05 5.9 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 15.1 | no trial data cached |
| Visual impairment | 203 | 10.4 9.1–11.8ROR 11.0 · χ² 1,713 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Limb injury | 44 | 10.2 7.6–13.7ROR 10.3 · χ² 355 / p 1e-79 | 9.7 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Platelet count increased | 21 | 10.1 6.6–15.4ROR 10.1 · χ² 163 / p 1e-37 | 9.1 EB05 6.0 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 16.8 · 100% clinician | no trial data cached |
| Vision blurred (blurred vision) | 209 | 9.6 8.4–10.9ROR 10.2 · χ² 1,609 / p <1e-300 | 9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 77% consumer | no trial data cached |
| Wound | 42 | 9.5 7.0–12.8ROR 9.6 · χ² 310 / p 1e-69 | 9.0 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Glaucoma | 29 | 9.4 6.6–13.6ROR 9.5 · χ² 210 / p 6e-48 | 8.7 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Haematocrit decreased | 28 | 8.8 6.1–12.7ROR 8.9 · χ² 186 / p 1e-42 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 | no trial data cached |
| Dry eye | 63 | 8.2 6.4–10.4ROR 8.3 · χ² 389 / p 8e-87 | 7.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.5 | no trial data cached |
| Autoimmune disorder | 12 | 7.9 4.5–13.8ROR 7.9 · χ² 65 / p 4e-16 | 6.4 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Pulmonary congestion | 16 | 7.6 4.6–12.4ROR 7.6 · χ² 85 / p 2e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 | no trial data cached |
| Eye inflammation | 11 | 7.3 4.1–13.2ROR 7.3 · χ² 54 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Sciatica | 18 | 7.1 4.5–11.3ROR 7.1 · χ² 89 / p 2e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Choking | 22 | 7.1 4.7–10.8ROR 7.1 · χ² 109 / p 7e-26 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Sinus disorder | 22 | 7.0 4.6–10.5ROR 7.0 · χ² 106 / p 3e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.5 | no trial data cached |
| Poor venous access | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 36 | 6.7 4.8–9.2ROR 6.7 · χ² 168 / p 1e-38 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Dry mouth | 86 | 6.7 5.4–8.2ROR 6.8 · χ² 409 / p 3e-91 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.1 | no trial data cached |
| Musculoskeletal chest pain | 16 | 6.5 4.0–10.6ROR 6.5 · χ² 69 / p 6e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.7 | no trial data cached |
| Kidney infection | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 1e-20 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Lacrimation increased | 30 | 6.3 4.4–9.0ROR 6.3 · χ² 128 / p 5e-30 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Salivary hypersecretion | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.6 | no trial data cached |
| Seasonal allergy | 14 | 6.2 3.7–10.5ROR 6.2 · χ² 56 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Eye discharge | 10 | 6.1 3.3–11.4ROR 6.2 · χ² 38 / p 4e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Productive cough (cough with phlegm) | 46 | 6.1 4.6–8.1ROR 6.2 · χ² 191 / p 1e-43 | 5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Impaired driving ability | 11 | 6.1 3.4–10.9ROR 6.1 · χ² 42 / p 6e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Therapeutic response shortened | 30 | 5.9 4.1–8.4ROR 6.0 · χ² 118 / p 1e-27 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Dental caries | 10 | 5.7 3.1–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Generalised oedema | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 6e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | 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 |
|---|---|---|---|---|---|---|
| Headache | 420 | 4.2 3.8–4.6ROR 4.7 · χ² 1,053 / p 3e-231 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Vision blurred (blurred vision) | 209 | 9.6 8.4–10.9ROR 10.2 · χ² 1,609 / p <1e-300 | 9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 77% consumer | no trial data cached |
| Visual impairment | 203 | 10.4 9.1–11.8ROR 11.0 · χ² 1,713 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Eye pain | 163 | 18.5 16.0–21.5ROR 19.4 · χ² 2,686 / p <1e-300 | 18.4 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 83% consumer | no trial data cached |
| Eye irritation | 141 | 15.9 13.5–18.7ROR 16.5 · χ² 1,951 / p <1e-300 | 15.8 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Weight increased (weight gain) | 100 | 2.8 2.3–3.4ROR 2.9 · χ² 116 / p 2e-27 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Urinary tract infection (bladder infection) | 95 | 3.5 2.9–4.3ROR 3.6 · χ² 168 / p 8e-39 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Ocular hyperaemia | 93 | 12.5 10.2–15.3ROR 12.8 · χ² 972 / p 1e-213 | 12.3 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 71% consumer | no trial data cached |
| Blood pressure increased | 91 | 3.7 3.0–4.6ROR 3.8 · χ² 180 / p 3e-41 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Dry mouth | 86 | 6.7 5.4–8.2ROR 6.8 · χ² 409 / p 3e-91 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.1 | no trial data cached |
| Vitreous floaters | 69 | 44.7 35.3–56.5ROR 45.6 · χ² 2,884 / p <1e-300 | 43.9 EB05 35.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 67 | 3.3 2.6–4.1ROR 3.3 · χ² 103 / p 2e-24 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Migraine | 64 | 4.2 3.3–5.4ROR 4.3 · χ² 155 / p 7e-36 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Dry eye | 63 | 8.2 6.4–10.4ROR 8.3 · χ² 389 / p 8e-87 | 7.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.5 | no trial data cached |
| Joint swelling | 59 | 3.1 2.4–4.0ROR 3.1 · χ² 81 / p 1e-19 | 3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | 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.
- Vitreous floaters — n=69, PRR 44.7
- Retinal detachment — n=48, PRR 32.9
- Ocular discomfort — n=30, PRR 17.3
- Eye irritation — n=141, PRR 15.9
- Sputum discoloured — n=20, PRR 13.3
- Ocular hyperaemia — n=93, PRR 12.5
- Vasculitis — n=23, PRR 12.4
- Photophobia — n=33, PRR 11.1
- Limb injury — n=44, PRR 10.2
- Wound — n=42, PRR 9.5
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?
In FDA FAERS, the most frequently co-reported reaction terms for Pilocarpine are headache, vision blurred, visual impairment, eye pain, eye irritation, weight increased. 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 have an FDA boxed warning?
No. The FDA label retrieved for Pilocarpine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pilocarpine 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 438cfaa3-b5f6-4d75-ac22-b0b4e07bb118, effective 20251003; matched on
openfda.generic_name.exact:"PILOCARPINE HYDROCHLORIDE") - 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, 214 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.