Mirabegron side effects: what 38,454 FDA adverse event reports show
Drug class
beta3-Adrenergic Agonist
Who reports
38,454 reports · 48% serious · 3,197 with death outcome · 67% female
Used for
Mirabegron extended-release tablets are a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
What it is
Mirabegron extended-release tablets for oral use is a beta-3 adrenergic agonist.
Boxed warning
None in the current label
Causality screen of the 40 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,133 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 |
|---|---|---|---|---|---|---|
| Hepatic enzyme | 74 | 620.8 444.4–867.4ROR 622.0 · calibrated p 3e-14 ✓ | 268.5 EB05 220.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 83 | 201.7 156.7–259.5ROR 202.1 · calibrated p 6e-10 ✓ | 142.1 EB05 118.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 635 | 137.7 126.2–150.1ROR 139.9 · calibrated p 8e-9 ✓ | 109.4 EB05 102.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=635 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Residual urine volume increased | 20 | 110.7 68.4–179.1ROR 110.8 · calibrated p 2e-7 ✓ | 84.8 EB05 57.9 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=17 | not reported in cached trials |
| Peripheral venous disease | 630 | 102.1 93.9–111.2ROR 103.8 · calibrated p 9e-8 ✓ | 85.8 EB05 80.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=629 · ♀ 96% (drug 67%) · 95% clinician | not reported in cached trials |
| Overlap syndrome | 98 | 90.3 72.9–111.8ROR 90.5 · calibrated p 3e-7 ✓ | 76.3 EB05 64.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=98 · ♀ 100% (drug 67%) · 91% clinician | not reported in cached trials |
| Onychomadesis | 550 | 83.2 76.1–90.9ROR 84.4 · calibrated p 4e-7 ✓ | 72.0 EB05 67.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=550 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Blepharospasm | 785 | 78.9 73.3–85.0ROR 80.6 · calibrated p 6e-7 ✓ | 68.8 EB05 64.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=779 · ♀ 100% (drug 67%) · 93% clinician | NCT00688688: 1/812 (0.1%) on Mirabegron (serious AE) |
| Rheumatic fever | 440 | 61.0 55.3–67.3ROR 61.7 · calibrated p 4e-6 ✓ | 54.8 EB05 50.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=440 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Breast cancer stage iii | 625 | 58.6 54.0–63.6ROR 59.6 · calibrated p 4e-6 ✓ | 52.9 EB05 49.5 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=625 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Swollen joint count | 23 | 56.1 36.5–86.2ROR 56.2 · calibrated p 2e-5 ✓ | 49.0 EB05 34.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Onychomycosis | 396 | 54.1 48.9–60.0ROR 54.7 · calibrated p 8e-6 ✓ | 49.2 EB05 45.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=393 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 629 | 52.9 48.8–57.4ROR 53.8 · calibrated p 9e-6 ✓ | 48.2 EB05 45.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 57.7 · ♀ 100% (drug 67%) · 98% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 626 | 50.8 46.8–55.1ROR 51.6 · calibrated p 1e-5 ✓ | 46.4 EB05 43.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 55.3 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Infusion site reaction | 238 | 48.6 42.6–55.4ROR 48.9 · calibrated p 2e-5 ✓ | 44.5 EB05 39.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=235 · ♀ 95% (drug 67%) · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 87 | 42.9 34.5–53.4ROR 43.0 · calibrated p 4e-5 ✓ | 39.5 EB05 33.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Muscle injury | 591 | 42.3 38.9–45.9ROR 42.9 · calibrated p 4e-5 ✓ | 39.2 EB05 36.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 50.7 · ♀ 100% (drug 67%) · 97% clinician | NCT00688688: 1/820 (0.1%) on Mirabegron (serious AE) |
| Subcutaneous drug absorption impaired | 39 | 42.0 30.3–58.1ROR 42.0 · calibrated p 6e-5 ✓ | 38.3 EB05 29.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Folliculitis | 732 | 41.5 38.6–44.7ROR 42.3 · calibrated p 4e-5 ✓ | 38.6 EB05 36.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.1 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Nocturia (night-time urination) | 774 | 37.2 34.6–40.0ROR 37.9 · calibrated p 7e-5 ✓ | 34.8 EB05 32.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 93% consumer | not reported in cached trials |
| Nail disorder | 554 | 37.1 34.0–40.4ROR 37.6 · calibrated p 8e-5 ✓ | 34.7 EB05 32.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=551 · ♀ 99% (drug 67%) · 96% clinician | not reported in cached trials |
| Lip dry | 553 | 35.8 32.9–39.0ROR 36.3 · calibrated p 9e-5 ✓ | 33.6 EB05 31.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=534 · ♀ 99% (drug 67%) · 93% clinician | not reported in cached trials |
| Helicobacter infection | 629 | 35.8 33.0–38.8ROR 36.4 · calibrated p 9e-5 ✓ | 33.6 EB05 31.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 42.2 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Hypercholesterolaemia | 590 | 35.8 32.9–38.9ROR 36.3 · calibrated p 9e-5 ✓ | 33.6 EB05 31.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 42.6 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Hypertonic bladder | 174 | 35.0 30.1–40.8ROR 35.2 · calibrated p 1e-4 ✓ | 32.8 EB05 28.9 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=100 · 72% consumer | NCT00688688: 1/820 (0.1%) on Mirabegron (serious AE) |
| Dislocation of vertebra | 133 | 34.6 29.1–41.2ROR 34.7 · calibrated p 1e-4 ✓ | 32.4 EB05 28.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=133 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Pemphigus | 742 | 34.6 32.1–37.2ROR 35.2 · calibrated p 1e-4 ✓ | 32.5 EB05 30.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 38.9 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Bursitis | 716 | 34.4 31.9–37.0ROR 35.0 · calibrated p 1e-4 ✓ | 32.3 EB05 30.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 45.2 · ♀ 99% (drug 67%) · 95% clinician | not reported in cached trials |
| Finger deformity | 280 | 33.4 29.6–37.6ROR 33.6 · calibrated p 1e-4 ✓ | 31.4 EB05 28.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=280 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| C-reactive protein abnormal | 366 | 33.0 29.7–36.6ROR 33.3 · calibrated p 2e-4 ✓ | 31.1 EB05 28.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=366 · ♀ 93% (drug 67%) · 94% clinician | not reported in cached trials |
| Vascular stenosis | 19 | 31.9 20.1–50.6ROR 31.9 · calibrated p 4e-4 ✓ | 29.4 EB05 19.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Urge incontinence | 47 | 31.5 23.5–42.2ROR 31.5 · calibrated p 3e-4 ✓ | 29.5 EB05 23.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious n=24 | not reported in cached trials |
| Deep vein thrombosis postoperative | 107 | 31.4 25.9–38.2ROR 31.5 · calibrated p 2e-4 ✓ | 29.6 EB05 25.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Wound infection | 591 | 31.3 28.8–34.0ROR 31.8 · calibrated p 2e-4 ✓ | 29.6 EB05 27.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 · ♀ 98% (drug 67%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 96 | 30.9 25.2–38.0ROR 31.0 · calibrated p 3e-4 ✓ | 29.2 EB05 24.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=96 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Urine flow decreased | 121 | 29.2 24.3–35.0ROR 29.2 · calibrated p 3e-4 ✓ | 27.6 EB05 23.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=49 · ♀ 31% (drug 67%) · 100% consumer | not reported in cached trials |
| Live birth | 408 | 28.1 25.4–31.0ROR 28.3 · calibrated p 4e-4 ✓ | 26.7 EB05 24.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 38.8 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Hand deformity | 620 | 27.1 25.0–29.3ROR 27.5 · calibrated p 4e-4 ✓ | 25.8 EB05 24.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Back injury | 510 | 26.9 24.6–29.4ROR 27.3 · calibrated p 4e-4 ✓ | 25.7 EB05 23.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 · ♀ 99% (drug 67%) · 93% clinician | not reported in cached trials |
| Bladder spasm | 82 | 25.1 20.1–31.3ROR 25.2 · calibrated p 8e-4 ✓ | 23.9 EB05 19.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 · 75% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Mirabegron as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT01972841 — This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and (N=3527, PHASE3; 55 AE terms posted; arms: Placebo; Mirabegron 25 mg; Mirabegron 50 mg; Solifenacin 5 mg)
- NCT00688688 — Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symp (N=2792, PHASE3; 157 AE terms posted; arms: Mirabegron 50 mg; Mirabegron 100 mg; Tolterodine ER 4 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 5,902 | 2.5 2.4–2.5ROR 2.7 · calibrated p 0.727 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 78% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 2,804 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.844 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
| Fatigue (tiredness) | 2,325 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.753 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00688688: 1/812 (0.1%) on Mirabegron (serious AE) |
| Headache | 2,259 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.961 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.7 | not reported in cached trials |
| Dizziness | 2,242 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.791 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | not reported in cached trials |
| Fall | 2,033 | 3.3 3.2–3.5ROR 3.5 · calibrated p 0.490 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | NCT00688688: 1/820 (0.1%) on Mirabegron (serious AE) |
| Diarrhoea (diarrhea) | 1,999 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.790 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Pain | 1,864 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.761 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00688688: 1/812 (0.1%) on Mirabegron (serious AE) |
| Nausea | 1,803 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.480 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Asthenia (weakness) | 1,582 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.878 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | not reported in cached trials |
| Hypertension (high blood pressure) | 1,565 | 4.0 3.9–4.2ROR 4.2 · calibrated p 0.347 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | NCT01972841: 1/848 (0.1%) on Mirabegron (serious AE) |
| Intentional product misuse | 1,542 | 9.8 9.4–10.3ROR 10.2 · calibrated p 0.030 ✓ | 9.7 EB05 9.3 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 87% consumer | not reported in cached trials |
| Blood pressure increased | 1,498 | 5.4 5.1–5.6ROR 5.6 · calibrated p 0.183 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 79% consumer | not reported in cached trials |
| Arthralgia (joint pain) | 1,492 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.947 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 3.4 | not reported in cached trials |
| Rash | 1,454 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.867 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.4 | not reported in cached trials |
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.
- Hepatic enzyme — n=74, PRR 620.8
- Hypocholesterolaemia — n=83, PRR 201.7
- Facet joint syndrome — n=635, PRR 137.7
- Peripheral venous disease — n=630, PRR 102.1
- Overlap syndrome — n=98, PRR 90.3
- Onychomadesis — n=550, PRR 83.2
- Blepharospasm — n=785, PRR 78.9 (also seen in trial arm)
- Rheumatic fever — n=440, PRR 61.0
- Swollen joint count — n=23, PRR 56.1
- Onychomycosis — n=396, PRR 54.1
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 Mirabegron?
In FDA FAERS, the most frequently co-reported reaction terms for Mirabegron are fatigue, headache, dizziness, fall, diarrhoea, pain. 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 Mirabegron have an FDA boxed warning?
No. The FDA label retrieved for Mirabegron has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Mirabegron 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 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2, effective 20241009; matched on
openfda.generic_name.exact:"MIRABEGRON") - 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, 1,173 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 - ClinicalTrials.gov API v2 (query
MIRABEGRON, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.