Drug · FAERS side-effect profile with label screen
Cevimeline Hydrochloride side effects: what 2,693 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,693 reports · 53% serious · 105 with death outcome · 88% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
FDA label, Indications and Usage
What it is
DESCRIPTION Cevimeline is cis -2’-methylspiro{1-azabicyclo [2.2.2] octane-3, 5’-[1,3] oxathiolane} hydrochloride, hydrate (2:1).
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 10Labeled (related wording) 9Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 19
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.
- 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. 153 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 |
|---|---|---|---|---|---|---|
| Seasonal allergy | 16 | 8.8 5.4–14.4ROR 8.9 · χ² 103 / p 1e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Infusion site pain | 14 | 8.5 5.1–14.4ROR 8.6 · χ² 86 / p 1e-20 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Dry mouth | 87 | 8.4 6.8–10.3ROR 8.6 · χ² 559 / p 7e-124 | 8.1 EB05 6.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.3 | no trial data cached |
| Impaired gastric emptying | 13 | 7.9 4.6–13.7ROR 8.0 · χ² 72 / p 1e-17 | 6.5 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Coeliac disease | 10 | 7.9 4.3–14.7ROR 8.0 · χ² 54 / p 1e-13 | 6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Ocular discomfort | 11 | 7.9 4.4–14.2ROR 7.9 · χ² 59 / p 6e-15 | 6.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Eye pain | 55 | 7.8 6.0–10.1ROR 7.9 · χ² 318 / p 2e-71 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 81% consumer | no trial data cached |
| Candida infection (yeast infection) | 16 | 7.5 4.6–12.2ROR 7.5 · χ² 83 / p 3e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Hereditary angioedema | 10 | 7.4 4.0–13.8ROR 7.4 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Dry eye | 44 | 7.1 5.3–9.5ROR 7.2 · χ² 224 / p 7e-51 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Dental caries | 10 | 7.1 3.8–13.1ROR 7.1 · χ² 46 / p 6e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Foot fracture | 17 | 7.0 4.3–11.2ROR 7.0 · χ² 81 / p 1e-19 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Sleep apnoea syndrome | 17 | 6.9 4.3–11.1ROR 7.0 · χ² 80 / p 2e-19 | 6.0 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Rotator cuff syndrome | 11 | 6.6 3.7–12.0ROR 6.7 · χ² 47 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Systemic lupus erythematosus | 30 | 6.6 4.6–9.4ROR 6.7 · χ² 137 / p 5e-32 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Sciatica | 13 | 6.4 3.7–11.0ROR 6.4 · χ² 54 / p 1e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Respiratory tract congestion | 12 | 5.9 3.3–10.3ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 | no trial data cached |
| Osteoarthritis | 32 | 5.9 4.2–8.3ROR 5.9 · χ² 125 / p 3e-29 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 76% consumer | no trial data cached |
| Localised infection | 18 | 5.8 3.7–9.2ROR 5.8 · χ² 67 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Fibromyalgia | 18 | 5.8 3.6–9.2ROR 5.8 · χ² 66 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Osteopenia | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 5e-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 |
| Bone disorder | 13 | 5.5 3.2–9.5ROR 5.5 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Bacterial infection | 13 | 5.5 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Eye irritation | 39 | 5.5 4.0–7.4ROR 5.5 · χ² 138 / p 5e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Pulmonary arterial hypertension | 10 | 5.3 2.9–9.9ROR 5.4 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Intervertebral disc protrusion | 15 | 5.3 3.2–8.8ROR 5.4 · χ² 49 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Neuralgia | 16 | 5.1 3.2–8.4ROR 5.2 · χ² 49 / p 1e-12 | 4.5 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Product use complaint | 10 | 5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8 | 4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Photophobia (light sensitivity) | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Cystitis | 20 | 4.9 3.1–7.5ROR 4.9 · χ² 58 / p 1e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Sinusitis | 64 | 4.9 3.8–6.2ROR 4.9 · χ² 193 / p 4e-44 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Clostridium difficile infection | 13 | 4.7 2.7–8.0ROR 4.7 · χ² 34 / p 3e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Pulmonary hypertension | 12 | 4.5 2.5–7.9ROR 4.5 · χ² 29 / p 4e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Mouth ulceration | 12 | 4.4 2.5–7.8ROR 4.5 · χ² 29 / p 4e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Lacrimation increased | 17 | 4.4 2.8–7.1ROR 4.5 · χ² 42 / p 5e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Osteomyelitis | 10 | 4.3 2.3–8.0ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Psoriatic arthropathy | 22 | 4.3 2.8–6.5ROR 4.3 · χ² 52 / p 3e-13 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Herpes zoster (shingles) | 31 | 4.2 3.0–6.0ROR 4.2 · χ² 72 / p 9e-18 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Tooth disorder | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 2e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Ear infection | 14 | 4.1 2.4–6.9ROR 4.1 · χ² 30 / p 2e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | 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 |
|---|---|---|---|---|---|---|
| Dry mouth | 87 | 8.4 6.8–10.3ROR 8.6 · χ² 559 / p 7e-124 | 8.1 EB05 6.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.3 | no trial data cached |
| Sinusitis | 64 | 4.9 3.8–6.2ROR 4.9 · χ² 193 / p 4e-44 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Injection site pain (pain where injected) | 55 | 1.4 1.1–1.8ROR 1.4 · χ² 6 / p 0.006 | 1.4 EB05 1.1 · IC025 +0.0 | Labeled (related wording) related wording | serious PRR 2.5 · 75% consumer | no trial data cached |
| Eye pain | 55 | 7.8 6.0–10.1ROR 7.9 · χ² 318 / p 2e-71 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 81% consumer | no trial data cached |
| Joint swelling | 51 | 3.3 2.5–4.3ROR 3.3 · χ² 80 / p 2e-19 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Rheumatoid arthritis | 44 | 3.0 2.3–4.1ROR 3.1 · χ² 58 / p 1e-14 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Dry eye | 44 | 7.1 5.3–9.5ROR 7.2 · χ² 224 / p 7e-51 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Eye irritation | 39 | 5.5 4.0–7.4ROR 5.5 · χ² 138 / p 5e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Bronchitis | 38 | 4.0 2.9–5.5ROR 4.0 · χ² 82 / p 7e-20 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Unevaluable event | 32 | 3.3 2.3–4.6ROR 3.3 · χ² 49 / p 1e-12 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Osteoarthritis | 32 | 5.9 4.2–8.3ROR 5.9 · χ² 125 / p 3e-29 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 76% consumer | no trial data cached |
| Herpes zoster (shingles) | 31 | 4.2 3.0–6.0ROR 4.2 · χ² 72 / p 9e-18 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Systemic lupus erythematosus | 30 | 6.6 4.6–9.4ROR 6.7 · χ² 137 / p 5e-32 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Drug dose omission | 29 | 1.3 0.9–1.9ROR 1.4 · χ² 2 / p 0.066 | 1.3 EB05 1.0 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.7 · 75% consumer | no trial data cached |
| Injection site erythema (redness where injected) | 26 | 1.6 1.1–2.4ROR 1.6 · χ² 6 / p 0.008 | 1.6 EB05 1.2 · IC025 +0.0 | Labeled (related wording) related wording | serious PRR 2.9 | 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.
- Dry eye — n=44, PRR 7.1
- Osteoarthritis — n=32, PRR 5.9
- Eye irritation — n=39, PRR 5.5
- Psoriatic arthropathy — n=22, PRR 4.3
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 Cevimeline?
In FDA FAERS, the most frequently co-reported reaction terms for Cevimeline are dry mouth, sinusitis, injection site pain, eye pain, joint swelling, rheumatoid arthritis. 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 Cevimeline have an FDA boxed warning?
No. The FDA label retrieved for Cevimeline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cevimeline 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 773a19e8-4c3e-4414-99a6-aea98c9790ee, effective 20220715; matched on
openfda.generic_name.exact:"CEVIMELINE") - 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, 193 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.