Drug · FAERS side-effect profile with label screen
Darifenacin Hydrobromide side effects: what 857 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Darifenacin
openFDA label
Who reports
857 reports · 79% serious · 106 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 ) Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
FDA label, Indications and Usage
What it is
Darifenacin is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.
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 38 strongest signals
Labeled adverse reaction 3Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 5Not in label — unassessed 22
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. 20 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 |
|---|---|---|---|---|---|---|
| Synovitis | 107 | 145.9 122.1–174.3ROR 166.6 · χ² 15,177 / p <1e-300 | 141.4 EB05 120.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 110.7 · ♀ 99% (drug 77%) | no trial data cached |
| Tenderness | 51 | 120.1 92.0–156.8ROR 127.6 · χ² 5,878 / p <1e-300 | 114.5 EB05 90.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 98% (drug 77%) | no trial data cached |
| Fibromyalgia | 100 | 101.2 84.1–121.7ROR 114.4 · χ² 9,787 / p <1e-300 | 98.9 EB05 83.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 96.6 · ♀ 99% (drug 77%) | no trial data cached |
| Oral pain | 80 | 87.4 70.9–107.8ROR 96.3 · χ² 6,732 / p <1e-300 | 85.4 EB05 70.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 116.5 · ♀ 99% (drug 77%) | no trial data cached |
| Liver function test abnormal | 89 | 74.6 61.3–90.9ROR 83.2 · χ² 6,381 / p <1e-300 | 73.3 EB05 61.4 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 67.6 · ♀ 97% (drug 77%) | no trial data cached |
| Herpes zoster (shingles) | 136 | 57.9 49.7–67.6ROR 68.7 · χ² 7,557 / p <1e-300 | 57.4 EB05 49.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 67.1 · ♀ 99% (drug 77%) | no trial data cached |
| Blood cholesterol increased | 97 | 51.0 42.3–61.5ROR 57.4 · χ² 4,705 / p <1e-300 | 50.4 EB05 42.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 56.3 | no trial data cached |
| Leukopenia (low white blood cells) | 96 | 47.2 39.1–57.0ROR 53.0 · χ² 4,294 / p <1e-300 | 46.7 EB05 39.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 · ♀ 98% (drug 77%) | no trial data cached |
| Contraindicated product administered | 43 | 34.9 26.1–46.7ROR 36.7 · χ² 1,383 / p <1e-300 | 34.4 EB05 26.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 31.7 · ♀ 50% (drug 77%) | no trial data cached |
| Arthritis | 98 | 30.5 25.3–36.7ROR 34.3 · χ² 2,771 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · ♀ 99% (drug 77%) | no trial data cached |
| Micturition urgency | 14 | 30.2 18.0–50.9ROR 30.7 · χ² 367 / p 4e-82 | 29.1 EB05 18.4 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 31.2 | no trial data cached |
| Arteriosclerosis | 10 | 26.0 14.0–48.1ROR 26.3 · χ² 216 / p 4e-49 | 24.7 EB05 14.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 | no trial data cached |
| Neuralgia | 25 | 25.2 17.2–37.2ROR 26.0 · χ² 558 / p 1e-123 | 24.8 EB05 17.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.3 · ♀ 100% (drug 77%) | no trial data cached |
| C-reactive protein increased | 36 | 24.2 17.6–33.4ROR 25.3 · χ² 780 / p 7e-172 | 24.0 EB05 18.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 18.4 | no trial data cached |
| Muscle spasticity | 12 | 23.7 13.5–41.6ROR 24.0 · χ² 239 / p 4e-54 | 22.8 EB05 13.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Thyroid disorder | 14 | 22.2 13.2–37.4ROR 22.6 · χ² 263 / p 2e-59 | 21.5 EB05 13.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.5 | no trial data cached |
| Peripheral swelling | 135 | 21.5 18.5–25.2ROR 25.4 · χ² 2,641 / p <1e-300 | 21.5 EB05 18.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.9 | no trial data cached |
| Adverse reaction | 11 | 20.3 11.3–36.5ROR 20.6 · χ² 183 / p 5e-42 | 19.3 EB05 10.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Secretion discharge | 10 | 19.8 10.7–36.7ROR 20.0 · χ² 160 / p 5e-37 | 18.6 EB05 9.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.7 | no trial data cached |
| Joint swelling | 97 | 19.7 16.3–23.8ROR 22.1 · χ² 1,713 / p <1e-300 | 19.6 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 98% (drug 77%) | no trial data cached |
| Osteopenia | 12 | 19.3 11.0–33.8ROR 19.5 · χ² 190 / p 2e-43 | 18.3 EB05 10.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Stomatitis (mouth sores) | 46 | 18.6 14.0–24.6ROR 19.6 · χ² 749 / p 4e-165 | 18.4 EB05 14.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 97% (drug 77%) | no trial data cached |
| Hypokinesia | 11 | 18.5 10.3–33.3ROR 18.8 · χ² 165 / p 4e-38 | 17.4 EB05 9.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 | no trial data cached |
| Therapeutic product effect incomplete | 53 | 18.4 14.1–23.8ROR 19.5 · χ² 855 / p 4e-188 | 18.2 EB05 14.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 24.7 · ♀ 98% (drug 77%) | no trial data cached |
| Blood pressure systolic increased | 14 | 17.5 10.4–29.4ROR 17.8 · χ² 202 / p 5e-46 | 16.7 EB05 10.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 13.9 | no trial data cached |
| Dementia | 19 | 16.7 10.7–26.1ROR 17.1 · χ² 265 / p 6e-60 | 16.2 EB05 10.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Lymphocyte count decreased | 12 | 16.6 9.5–29.1ROR 16.8 · χ² 161 / p 4e-37 | 15.5 EB05 8.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Infection | 87 | 14.8 12.1–18.0ROR 16.3 · χ² 1,110 / p 1e-243 | 14.7 EB05 12.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Psychomotor hyperactivity | 10 | 14.7 7.9–27.2ROR 14.8 · χ² 114 / p 6e-27 | 12.9 EB05 6.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 | no trial data cached |
| Intervertebral disc protrusion | 12 | 13.4 7.6–23.5ROR 13.6 · χ² 126 / p 2e-29 | 11.9 EB05 6.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Swelling | 50 | 13.1 10.0–17.2ROR 13.9 · χ² 549 / p 9e-122 | 12.9 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 | no trial data cached |
| Musculoskeletal disorder | 10 | 12.8 6.9–23.7ROR 12.9 · χ² 97 / p 3e-23 | 10.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Urinary retention | 17 | 12.5 7.8–20.0ROR 12.7 · χ² 169 / p 7e-39 | 11.5 EB05 7.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | no trial data cached |
| Urinary incontinence | 14 | 11.6 6.9–19.5ROR 11.7 · χ² 125 / p 3e-29 | 10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.5 | no trial data cached |
| Bone density decreased | 11 | 8.5 4.7–15.3ROR 8.6 · χ² 66 / p 3e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Rheumatoid arthritis | 25 | 5.4 3.7–8.0ROR 5.5 · χ² 86 / p 9e-21 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Multiple sclerosis relapse | 10 | 3.5 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Device issue | 10 | 2.8 1.5–5.2ROR 2.8 · χ² 10 / p 8e-4 | 2.6 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 9.7 | 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 |
|---|---|---|---|---|---|---|
| Herpes zoster (shingles) | 136 | 57.9 49.7–67.6ROR 68.7 · χ² 7,557 / p <1e-300 | 57.4 EB05 49.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 67.1 · ♀ 99% (drug 77%) | no trial data cached |
| Peripheral swelling | 135 | 21.5 18.5–25.2ROR 25.4 · χ² 2,641 / p <1e-300 | 21.5 EB05 18.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.9 | no trial data cached |
| Synovitis | 107 | 145.9 122.1–174.3ROR 166.6 · χ² 15,177 / p <1e-300 | 141.4 EB05 120.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 110.7 · ♀ 99% (drug 77%) | no trial data cached |
| Fibromyalgia | 100 | 101.2 84.1–121.7ROR 114.4 · χ² 9,787 / p <1e-300 | 98.9 EB05 83.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 96.6 · ♀ 99% (drug 77%) | no trial data cached |
| Arthritis | 98 | 30.5 25.3–36.7ROR 34.3 · χ² 2,771 / p <1e-300 | 30.3 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · ♀ 99% (drug 77%) | no trial data cached |
| Joint swelling | 97 | 19.7 16.3–23.8ROR 22.1 · χ² 1,713 / p <1e-300 | 19.6 EB05 16.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 98% (drug 77%) | no trial data cached |
| Blood cholesterol increased | 97 | 51.0 42.3–61.5ROR 57.4 · χ² 4,705 / p <1e-300 | 50.4 EB05 42.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 56.3 | no trial data cached |
| Leukopenia (low white blood cells) | 96 | 47.2 39.1–57.0ROR 53.0 · χ² 4,294 / p <1e-300 | 46.7 EB05 39.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 · ♀ 98% (drug 77%) | no trial data cached |
| Liver function test abnormal | 89 | 74.6 61.3–90.9ROR 83.2 · χ² 6,381 / p <1e-300 | 73.3 EB05 61.4 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 67.6 · ♀ 97% (drug 77%) | no trial data cached |
| Infection | 87 | 14.8 12.1–18.0ROR 16.3 · χ² 1,110 / p 1e-243 | 14.7 EB05 12.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Oral pain | 80 | 87.4 70.9–107.8ROR 96.3 · χ² 6,732 / p <1e-300 | 85.4 EB05 70.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 116.5 · ♀ 99% (drug 77%) | no trial data cached |
| Therapeutic product effect incomplete | 53 | 18.4 14.1–23.8ROR 19.5 · χ² 855 / p 4e-188 | 18.2 EB05 14.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 24.7 · ♀ 98% (drug 77%) | no trial data cached |
| Tenderness | 51 | 120.1 92.0–156.8ROR 127.6 · χ² 5,878 / p <1e-300 | 114.5 EB05 90.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 98% (drug 77%) | no trial data cached |
| Swelling | 50 | 13.1 10.0–17.2ROR 13.9 · χ² 549 / p 9e-122 | 12.9 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 | no trial data cached |
| Stomatitis (mouth sores) | 46 | 18.6 14.0–24.6ROR 19.6 · χ² 749 / p 4e-165 | 18.4 EB05 14.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 97% (drug 77%) | 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.
- Synovitis — n=107, PRR 145.9
- Tenderness — n=51, PRR 120.1
- Fibromyalgia — n=100, PRR 101.2
- Oral pain — n=80, PRR 87.4
- Herpes zoster — n=136, PRR 57.9
- Leukopenia — n=96, PRR 47.2
- Arthritis — n=98, PRR 30.5
- Neuralgia — n=25, PRR 25.2
- Joint swelling — n=97, PRR 19.7
- Stomatitis — n=46, PRR 18.6
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 Darifenacin Hydrobromide?
In FDA FAERS, the most frequently co-reported reaction terms for Darifenacin Hydrobromide are herpes zoster, peripheral swelling, synovitis, fibromyalgia, arthritis, joint swelling. 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 Darifenacin Hydrobromide have an FDA boxed warning?
No. The FDA label retrieved for Darifenacin Hydrobromide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Darifenacin Hydrobromide 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 6e8470d1-c3e6-4644-b70a-aa47ddf79676, effective 20251027; matched on
openfda.generic_name.exact:"DARIFENACIN HYDROBROMIDE") - 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, 58 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.