Nadolol side effects: what 7,530 FDA adverse event reports show
Who reports
7,530 reports · 70% serious · 612 with death outcome · 66% female
Used for
Angina Pectoris Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
What it is
DESCRIPTION Nadolol tablets, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert -butyl-amino)-3-[(5,6,7,8-tetrahydro- cis -6,7-dihydroxy-1-naphthyl) oxy]-2-propanol.
Boxed warning
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal - Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.
Causality screen of the 40 strongest signals
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. 642 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 831 | 208.8 195.3–223.3ROR 234.6 · χ² 159,631 / p <1e-300 | 193.3 EB05 182.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 172.8 · ♀ 100% (drug 66%) | no trial data cached |
| Vaginal discharge | 189 | 53.4 46.3–61.5ROR 54.7 · χ² 9,482 / p <1e-300 | 52.1 EB05 46.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=188 · ♀ 100% (drug 66%) | no trial data cached |
| Paraesthesia oral | 245 | 48.3 42.6–54.7ROR 49.9 · χ² 11,108 / p <1e-300 | 47.3 EB05 42.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 69.2 · ♀ 100% (drug 66%) | no trial data cached |
| Oral candidiasis (oral thrush) | 196 | 42.6 37.0–48.9ROR 43.7 · χ² 7,800 / p <1e-300 | 41.8 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.6 · ♀ 98% (drug 66%) | no trial data cached |
| Hepatic encephalopathy | 85 | 25.6 20.7–31.6ROR 25.8 · χ² 1,964 / p <1e-300 | 25.2 EB05 21.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.0 · ♀ 23% (drug 66%) | no trial data cached |
| Procedural pain | 230 | 23.3 20.5–26.5ROR 24.0 · χ² 4,861 / p <1e-300 | 23.1 EB05 20.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 · ♀ 99% (drug 66%) | no trial data cached |
| Frequent bowel movements | 208 | 21.7 19.0–24.8ROR 22.3 · χ² 4,057 / p <1e-300 | 21.5 EB05 19.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.8 · ♀ 95% (drug 66%) | no trial data cached |
| Hepatic cirrhosis | 131 | 19.6 16.6–23.3ROR 20.0 · χ² 2,286 / p <1e-300 | 19.5 EB05 16.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Rectal haemorrhage | 263 | 17.1 15.2–19.2ROR 17.7 · χ² 3,950 / p <1e-300 | 17.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 92% (drug 66%) | no trial data cached |
| Colitis | 202 | 15.0 13.1–17.2ROR 15.4 · χ² 2,617 / p <1e-300 | 14.9 EB05 13.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.2 · ♀ 98% (drug 66%) | no trial data cached |
| Colitis ulcerative | 207 | 13.0 11.3–14.8ROR 13.3 · χ² 2,271 / p <1e-300 | 12.9 EB05 11.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · ♀ 96% (drug 66%) | no trial data cached |
| Haematochezia (blood in stool) | 240 | 12.2 10.7–13.8ROR 12.5 · χ² 2,446 / p <1e-300 | 12.1 EB05 10.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 89% (drug 66%) | no trial data cached |
| Splenomegaly | 49 | 11.7 8.8–15.5ROR 11.8 · χ² 467 / p 7e-104 | 11.3 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Therapeutic product effect incomplete | 289 | 11.4 10.2–12.8ROR 11.8 · χ² 2,736 / p <1e-300 | 11.3 EB05 10.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.4 · ♀ 98% (drug 66%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 268 | 11.3 10.1–12.8ROR 11.7 · χ² 2,514 / p <1e-300 | 11.2 EB05 10.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 98% (drug 66%) | no trial data cached |
| Ascites | 96 | 9.1 7.5–11.1ROR 9.2 · χ² 684 / p 5e-151 | 8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 41% (drug 66%) | no trial data cached |
| Ligament sprain | 31 | 8.8 6.2–12.5ROR 8.8 · χ² 205 / p 8e-47 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 66%) | no trial data cached |
| Dyspepsia (indigestion) | 284 | 8.1 7.2–9.1ROR 8.4 · χ² 1,758 / p <1e-300 | 8.0 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 94% (drug 66%) | no trial data cached |
| Inability to afford medication | 27 | 7.7 5.3–11.2ROR 7.7 · χ² 149 / p 1e-34 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Ventricular tachycardia | 43 | 7.2 5.4–9.8ROR 7.3 · χ² 225 / p 4e-51 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 93% clinician | no trial data cached |
| Hepatic failure | 77 | 7.1 5.7–8.9ROR 7.2 · χ² 398 / p 9e-89 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 34% (drug 66%) | no trial data cached |
| Hypomagnesaemia | 33 | 6.6 4.7–9.3ROR 6.7 · χ² 152 / p 3e-35 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 93% (drug 66%) · 90% clinician | no trial data cached |
| Blood pressure systolic increased | 44 | 6.3 4.7–8.4ROR 6.3 · χ² 189 / p 2e-43 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.5 · ♀ 88% (drug 66%) | no trial data cached |
| Atelectasis | 19 | 5.5 3.5–8.6ROR 5.5 · χ² 65 / p 4e-16 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Haematemesis (vomiting blood) | 49 | 5.4 4.1–7.1ROR 5.4 · χ² 170 / p 4e-39 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Heart rate decreased | 68 | 5.4 4.2–6.8ROR 5.4 · χ² 238 / p 6e-54 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Electrocardiogram qt prolonged | 69 | 5.3 4.2–6.8ROR 5.4 · χ² 239 / p 3e-54 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Sinus congestion | 25 | 5.2 3.5–7.6ROR 5.2 · χ² 79 / p 2e-19 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=17 · ♀ 100% (drug 66%) | no trial data cached |
| Anaemia (low red blood cells) | 348 | 5.1 4.6–5.6ROR 5.3 · χ² 1,146 / p 2e-251 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Insurance issue | 27 | 5.1 3.5–7.4ROR 5.1 · χ² 84 / p 2e-20 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Ventricular extrasystoles | 18 | 4.8 3.0–7.7ROR 4.8 · χ² 51 / p 5e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Weight decreased (weight loss) | 463 | 4.6 4.2–5.1ROR 4.9 · χ² 1,328 / p 5e-291 | 4.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 86% (drug 66%) | no trial data cached |
| Bursitis | 20 | 4.6 3.0–7.2ROR 4.6 · χ² 53 / p 2e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Mental status changes | 46 | 4.6 3.5–6.2ROR 4.6 · χ² 127 / p 1e-29 | 4.4 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypocalcaemia (low calcium) | 31 | 4.6 3.2–6.5ROR 4.6 · χ² 83 / p 4e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 100% clinician | no trial data cached |
| Hepatitis c | 20 | 4.6 2.9–7.1ROR 4.6 · χ² 52 / p 3e-13 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Skin infection | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 8e-12 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Upper gastrointestinal haemorrhage | 27 | 4.5 3.1–6.5ROR 4.5 · χ² 69 / p 5e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 25% (drug 66%) | no trial data cached |
| Bradycardia (slow heart rate) | 84 | 4.4 3.6–5.5ROR 4.4 · χ² 218 / p 1e-49 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · ♀ 42% (drug 66%) · 92% clinician | no trial data cached |
| Blood iron decreased | 18 | 4.3 2.7–6.8ROR 4.3 · χ² 42 / p 6e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 1,306 | 2.8 2.6–2.9ROR 3.1 · χ² 1,565 / p <1e-300 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · ♀ 87% (drug 66%) | no trial data cached |
| Macular degeneration | 831 | 208.8 195.3–223.3ROR 234.6 · χ² 159,631 / p <1e-300 | 193.3 EB05 182.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 172.8 · ♀ 100% (drug 66%) | no trial data cached |
| Nausea | 672 | 2.4 2.2–2.6ROR 2.5 · χ² 553 / p 2e-122 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Off label use (used outside approved label) | 603 | 1.9 1.8–2.1ROR 2.0 · χ² 283 / p 8e-64 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Headache | 603 | 2.7 2.5–2.9ROR 2.8 · χ² 654 / p 2e-144 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Fatigue (tiredness) | 526 | 1.9 1.7–2.0ROR 2.0 · χ² 226 / p 2e-51 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Pain | 513 | 2.3 2.1–2.5ROR 2.4 · χ² 396 / p 2e-88 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Weight decreased (weight loss) | 463 | 4.6 4.2–5.1ROR 4.9 · χ² 1,328 / p 5e-291 | 4.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 86% (drug 66%) | no trial data cached |
| Diarrhoea (diarrhea) | 443 | 1.9 1.8–2.1ROR 2.0 · χ² 200 / p 1e-45 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Malaise (feeling unwell) | 419 | 2.7 2.4–2.9ROR 2.8 · χ² 440 / p 6e-98 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · ♀ 88% (drug 66%) | no trial data cached |
| Pyrexia (fever) | 403 | 3.2 2.9–3.6ROR 3.4 · χ² 633 / p 6e-140 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Anaemia (low red blood cells) | 348 | 5.1 4.6–5.6ROR 5.3 · χ² 1,146 / p 2e-251 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Dizziness | 339 | 1.9 1.7–2.1ROR 1.9 · χ² 146 / p 6e-34 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Abdominal pain | 323 | 3.9 3.5–4.3ROR 4.0 · χ² 692 / p 8e-153 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 319 | 1.6 1.4–1.7ROR 1.6 · χ² 67 / p 1e-16 | 1.6 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.5 | 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.
- Macular degeneration — n=831, PRR 208.8
- Vaginal discharge — n=189, PRR 53.4
- Paraesthesia oral — n=245, PRR 48.3
- Oral candidiasis — n=196, PRR 42.6
- Hepatic encephalopathy — n=85, PRR 25.6
- Procedural pain — n=230, PRR 23.3
- Frequent bowel movements — n=208, PRR 21.7
- Hepatic cirrhosis — n=131, PRR 19.6
- Rectal haemorrhage — n=263, PRR 17.1
- Colitis ulcerative — n=207, PRR 13.0
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 Nadolol?
In FDA FAERS, the most frequently co-reported reaction terms for Nadolol are macular degeneration, nausea, headache, fatigue, pain, weight decreased. 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 Nadolol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal - Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.
Do FAERS signals prove that Nadolol 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 15822faf-6924-4a63-a4e1-6058b308708c, effective 20250409; matched on
openfda.generic_name.exact:"NADOLOL") - 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, 682 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.