Metoprolol Er side effects: what 62,027 FDA adverse event reports show
Drug class
Beta-adrenergic blocker
Label matched
Metoprolol Succinate Er Tablets (Metoprolol Succinate)
Who reports
62,027 reports · 63% serious · 5,873 with death outcome · 55% female
Used for
Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Angina Pectoris.
What it is
Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration.
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.
- 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, 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). 1,139 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 |
|---|---|---|---|---|---|---|
| Pancreatic steatosis | 38 | 56.1 39.8–79.1ROR 56.2 · calibrated p 1e-5 ✓ | 47.1 EB05 35.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Suspected suicide | 375 | 28.8 25.9–32.0ROR 28.9 · calibrated p 3e-4 ✓ | 26.5 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=375 · 100% clinician | not reported in cached trials |
| Brash syndrome | 105 | 28.3 23.2–34.5ROR 28.3 · calibrated p 4e-4 ✓ | 26.0 EB05 22.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=105 · 100% clinician | not reported in cached trials |
| Periorbital pain | 43 | 19.1 14.0–25.9ROR 19.1 · calibrated p 0.003 ✓ | 17.9 EB05 13.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Arterial haemorrhage | 49 | 15.0 11.3–20.0ROR 15.0 · calibrated p 0.008 ✓ | 14.2 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 46 | 11.5 8.6–15.4ROR 11.5 · calibrated p 0.022 ✓ | 10.8 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 55%) | not reported in cached trials |
| Infusion site discharge | 54 | 11.0 8.4–14.4ROR 11.0 · calibrated p 0.026 ✓ | 10.3 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Aortic valve stenosis | 55 | 10.7 8.2–14.0ROR 10.7 · calibrated p 0.028 ✓ | 10.0 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 143 | 10.6 9.0–12.6ROR 10.6 · calibrated p 0.027 ✓ | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=143 | not reported in cached trials |
| Eyelid pain | 59 | 10.6 8.2–13.7ROR 10.6 · calibrated p 0.029 ✓ | 10.0 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Tachyarrhythmia | 73 | 10.1 8.0–12.8ROR 10.1 · calibrated p 0.033 ✓ | 9.6 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=73 · 100% clinician | not reported in cached trials |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 65 | 9.2 7.2–11.8ROR 9.2 · calibrated p 0.045 ✓ | 8.7 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Essential hypertension | 67 | 8.9 7.0–11.4ROR 9.0 · calibrated p 0.050 ✓ | 8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=61 | not reported in cached trials |
| Hyperparathyroidism secondary | 64 | 8.7 6.8–11.2ROR 8.7 · calibrated p 0.054 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=64 | not reported in cached trials |
| Aortic arteriosclerosis | 62 | 8.3 6.4–10.7ROR 8.3 · calibrated p 0.063 | 7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Infusion site haemorrhage | 77 | 8.2 6.5–10.3ROR 8.2 · calibrated p 0.065 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=45 · 100% consumer | not reported in cached trials |
| Chronic gastritis | 53 | 8.2 6.2–10.7ROR 8.2 · calibrated p 0.067 | 7.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=53 · ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Blood pressure inadequately controlled | 133 | 7.6 6.4–9.0ROR 7.6 · calibrated p 0.081 | 7.3 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=81 | not reported in cached trials |
| Infusion site bruising | 46 | 7.4 5.6–10.0ROR 7.4 · calibrated p 0.089 | 6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 55%) | not reported in cached trials |
| Diastolic dysfunction | 67 | 7.4 5.8–9.5ROR 7.4 · calibrated p 0.087 | 7.0 EB05 5.7 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=62 | not reported in cached trials |
| Diverticulum intestinal | 92 | 7.3 5.9–8.9ROR 7.3 · calibrated p 0.092 | 6.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 76% (drug 55%) | not reported in cached trials |
| Rebound acid hypersecretion | 62 | 6.9 5.4–8.9ROR 7.0 · calibrated p 0.106 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=61 | not reported in cached trials |
| Hepatic cyst | 68 | 6.9 5.4–8.8ROR 6.9 · calibrated p 0.108 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 100% (drug 55%) | not reported in cached trials |
| Product administration interrupted | 151 | 6.8 5.8–7.9ROR 6.8 · calibrated p 0.110 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=125 | not reported in cached trials |
| Seasonal allergy | 276 | 6.7 6.0–7.6ROR 6.7 · calibrated p 0.111 | 6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=119 · 77% consumer | not reported in cached trials |
| Atrial flutter | 148 | 6.3 5.4–7.5ROR 6.3 · calibrated p 0.132 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | not reported in cached trials |
| Infusion site swelling | 103 | 5.7 4.7–7.0ROR 5.7 · calibrated p 0.172 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=55 · 81% consumer | not reported in cached trials |
| Sinus bradycardia | 160 | 5.7 4.8–6.6ROR 5.7 · calibrated p 0.176 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 100% clinician | not reported in cached trials |
| Oxygen consumption increased | 39 | 5.7 4.1–7.8ROR 5.7 · calibrated p 0.184 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Device infusion issue | 40 | 5.6 4.1–7.6ROR 5.6 · calibrated p 0.190 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | ♀ 100% (drug 55%) · 100% consumer | not reported in cached trials |
| Arteriosclerosis coronary artery | 107 | 5.5 4.6–6.7ROR 5.6 · calibrated p 0.186 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=106 | not reported in cached trials |
| Tricuspid valve incompetence | 128 | 5.5 4.7–6.6ROR 5.6 · calibrated p 0.186 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 76% (drug 55%) | not reported in cached trials |
| Ventricular hypokinesia | 52 | 5.5 4.2–7.3ROR 5.5 · calibrated p 0.192 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Ventricular extrasystoles | 166 | 5.5 4.7–6.4ROR 5.5 · calibrated p 0.191 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | not reported in cached trials |
| Infusion site erythema | 130 | 5.4 4.5–6.4ROR 5.4 · calibrated p 0.201 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 76% (drug 55%) · 79% consumer | not reported in cached trials |
| Mitral valve incompetence | 176 | 5.3 4.6–6.2ROR 5.3 · calibrated p 0.204 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | not reported in cached trials |
| Coronary artery occlusion | 214 | 5.3 4.6–6.1ROR 5.3 · calibrated p 0.204 | 5.2 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | not reported in cached trials |
| Coronary artery stenosis | 78 | 5.3 4.2–6.6ROR 5.3 · calibrated p 0.211 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=77 | not reported in cached trials |
| Bundle branch block left | 66 | 5.3 4.1–6.7ROR 5.3 · calibrated p 0.212 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=66 · 100% clinician | not reported in cached trials |
| Atrial fibrillation | 1,507 | 5.3 5.0–5.6ROR 5.4 · calibrated p 0.196 | 5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | 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 Metoprolol Er 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 (0 of 40 signal terms matched).
- NCT02587351 — Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (N=532, PHASE3; 28 AE terms posted; arms: Metoprolol Succinate; Placebo)
- NCT00744237 — Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients (N=231, PHASE4; 20 AE terms posted; arms: Nebivolol; Metoprolol ER; Hydrochlorothiazide (HCTZ))
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 4,821 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.954 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 | NCT00744237: 1/73 (1.4%) on Metoprolol Er |
| Diarrhoea (diarrhea) | 3,930 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.981 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 3,752 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.889 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Nausea | 3,715 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.726 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Dizziness | 3,110 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.964 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT02587351: 23/268 (8.6%) on Metoprolol Er; 16/264 (6.1%) control |
| Off label use (used outside approved label) | 3,000 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.424 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,994 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.159 | 0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Headache | 2,832 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.678 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT02587351: 18/268 (6.7%) on Metoprolol Er; 15/264 (5.7%) control |
| Death | 2,587 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.316 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | not reported in cached trials |
| Asthenia (weakness) | 2,377 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.958 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Pain | 2,244 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.468 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT02587351: 1/268 (0.4%) on Metoprolol Er; 1/264 (0.4%) control (serious AE) |
| Fall | 2,160 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.929 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | not reported in cached trials |
| Cough | 1,973 | 2.4 2.3–2.5ROR 2.4 · calibrated p 0.840 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | NCT00744237: 6/73 (8.2%) on Metoprolol Er |
| Pneumonia (lung infection) | 1,931 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.975 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.9 | NCT02587351: 14/268 (5.2%) on Metoprolol Er; 11/264 (4.2%) control (serious AE) |
| Vomiting | 1,849 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.537 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | 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.
- Pancreatic steatosis — n=38, PRR 56.1
- Suspected suicide — n=375, PRR 28.8
- Brash syndrome — n=105, PRR 28.3
- Periorbital pain — n=43, PRR 19.1
- Arterial haemorrhage — n=49, PRR 15.0
- Obstructive sleep apnoea syndrome — n=46, PRR 11.5
- Infusion site discharge — n=54, PRR 11.0
- Aortic valve stenosis — n=55, PRR 10.7
- Nephrogenic anaemia — n=143, PRR 10.6
- Eyelid pain — n=59, PRR 10.6
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 Metoprolol Er?
In FDA FAERS, the most frequently co-reported reaction terms for Metoprolol Er are fatigue, diarrhoea, dyspnoea, nausea, dizziness, headache. 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 Metoprolol Er have an FDA boxed warning?
No. The FDA label retrieved for Metoprolol Er has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Metoprolol Er 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 01908d20-0e16-4410-bd27-1b6df162ede4, effective 20250401; matched on
openfda.generic_name.exact:"METOPROLOL SUCCINATE ER TABLETS") - 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, 1,179 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
METOPROLOL ER, 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.