Propranolol side effects: what 71,644 FDA adverse event reports show

Propranolol Hydrochloride · 1,168 reaction terms · 289,334 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

71,644 reports · 70% serious · 7,184 with death outcome · 67% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Cardiac Arrhythmias Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1. Supraventricular arrhythmias Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff-Parkinson-White syndrome and thyrotoxicosis, to decrease ventricular rate.

FDA label, Indications and Usage

What it is

Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)- 1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is:

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 1Likely indication confounding 3Reporting / coding artifact 5Lab value / disease marker 2Not in label — unassessed 29

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.
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). 1,128 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Infantile spitting up	196	177.9 148.9–212.6ROR 178.4 · calibrated p 1e-9 ✓	109.2 EB05 96.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Neovascularisation	64	97.4 73.4–129.4ROR 97.5 · calibrated p 2e-7 ✓	71.5 EB05 58.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=64 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Amaurosis fugax	222	76.6 66.1–88.8ROR 76.8 · calibrated p 9e-7 ✓	60.4 EB05 54.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=222 · 100% clinician	no trial arm names this drug
Product administered to patient of inappropriate age	1,169	70.7 66.3–75.3ROR 71.8 · calibrated p 1e-6 ✓	56.9 EB05 54.2 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	serious n=170	no trial arm names this drug
Paranasal cyst	46	69.3 50.2–95.6ROR 69.3 · calibrated p 3e-6 ✓	54.8 EB05 42.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=46 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Haemangioma	348	51.6 46.0–57.8ROR 51.8 · calibrated p 1e-5 ✓	43.8 EB05 40.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Granuloma skin	103	41.5 33.7–51.0ROR 41.5 · calibrated p 5e-5 ✓	36.1 EB05 30.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=103 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Phonophobia	48	34.1 25.3–46.0ROR 34.1 · calibrated p 2e-4 ✓	30.3 EB05 23.7 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=47 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Reversible airways obstruction	51	32.1 24.0–42.9ROR 32.1 · calibrated p 2e-4 ✓	28.7 EB05 22.7 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=51 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Cerebral artery thrombosis	48	29.9 22.2–40.2ROR 29.9 · calibrated p 4e-4 ✓	26.9 EB05 21.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Brain scan abnormal	46	26.1 19.3–35.3ROR 26.1 · calibrated p 7e-4 ✓	23.8 EB05 18.6 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=46 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Thyrotoxic crisis	90	25.2 20.4–31.3ROR 25.3 · calibrated p 7e-4 ✓	23.2 EB05 19.4 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=90 · 100% clinician	no trial arm names this drug
Hypoglycaemic seizure	70	24.2 19.0–30.9ROR 24.2 · calibrated p 9e-4 ✓	22.3 EB05 18.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=70 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Blood parathyroid hormone decreased	109	23.0 18.9–28.0ROR 23.0 · calibrated p 0.001 ✓	21.3 EB05 18.2 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=109 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Essential tremor	81	22.8 18.2–28.6ROR 22.9 · calibrated p 0.001 ✓	21.1 EB05 17.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=57	no trial arm names this drug
Phaeochromocytoma	47	22.2 16.5–29.8ROR 22.2 · calibrated p 0.002 ✓	20.5 EB05 16.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Medication overuse headache	57	20.8 15.9–27.3ROR 20.9 · calibrated p 0.002 ✓	19.4 EB05 15.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Oesophageal varices haemorrhage	112	15.8 13.1–19.2ROR 15.9 · calibrated p 0.006 ✓	15.0 EB05 12.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=111 · ♀ 0% (drug 67%)	no trial arm names this drug
Mastoiditis	48	15.1 11.3–20.2ROR 15.2 · calibrated p 0.008 ✓	14.3 EB05 11.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 100% (drug 67%)	no trial arm names this drug
Product ineffective for unapproved use	68	14.9 11.7–19.0ROR 14.9 · calibrated p 0.008 ✓	14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=53 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Urinary tract disorder	216	14.7 12.8–16.9ROR 14.8 · calibrated p 0.008 ✓	14.0 EB05 12.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=212 · 91% clinician	no trial arm names this drug
Product used for unknown indication	59	14.5 11.2–18.8ROR 14.5 · calibrated p 0.009 ✓	13.7 EB05 10.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious n=54 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Postural orthostatic tachycardia syndrome	60	14.0 10.8–18.1ROR 14.0 · calibrated p 0.010 ✓	13.2 EB05 10.6 · IC025 +3.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=48 · ♀ 100% (drug 67%) · 100% consumer	no trial arm names this drug
Panniculitis	108	13.7 11.3–16.6ROR 13.7 · calibrated p 0.011 ✓	13.0 EB05 11.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=108 · ♀ 100% (drug 67%) · 100% clinician	no trial arm names this drug
Varices oesophageal	132	13.3 11.2–15.9ROR 13.4 · calibrated p 0.012 ✓	12.7 EB05 11.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=131 · ♀ 37% (drug 67%)	no trial arm names this drug
Electrocardiogram qrs complex prolonged	210	12.5 10.9–14.3ROR 12.5 · calibrated p 0.015 ✓	12.0 EB05 10.6 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=210 · 100% clinician	no trial arm names this drug
Rheumatoid nodule	110	12.0 9.9–14.5ROR 12.0 · calibrated p 0.018 ✓	11.4 EB05 9.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=110 · ♀ 100% (drug 67%)	no trial arm names this drug
Drug titration error	99	11.6 9.5–14.2ROR 11.6 · calibrated p 0.020 ✓	11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Pulseless electrical activity	156	11.3 9.7–13.3ROR 11.4 · calibrated p 0.021 ✓	10.8 EB05 9.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=156	no trial arm names this drug
Haemorrhagic stroke	275	10.6 9.4–11.9ROR 10.6 · calibrated p 0.027 ✓	10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · 94% clinician	no trial arm names this drug
Areflexia	92	10.3 8.4–12.7ROR 10.3 · calibrated p 0.030 ✓	9.8 EB05 8.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=92 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Hepatorenal syndrome	57	10.1 7.8–13.2ROR 10.2 · calibrated p 0.033 ✓	9.5 EB05 7.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=57 · ♀ 0% (drug 67%) · 100% clinician	no trial arm names this drug
Agoraphobia	46	10.1 7.6–13.6ROR 10.1 · calibrated p 0.034 ✓	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=46 · 100% consumer	no trial arm names this drug
Neoplasm skin	50	9.7 7.3–12.8ROR 9.7 · calibrated p 0.039 ✓	9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 100% (drug 67%)	no trial arm names this drug
Migraine with aura	83	9.2 7.4–11.5ROR 9.2 · calibrated p 0.045 ✓	8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=76	no trial arm names this drug
Depersonalisation/derealisation disorder	49	9.2 6.9–12.2ROR 9.2 · calibrated p 0.047 ✓	8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 100% (drug 67%) · 100% consumer	no trial arm names this drug
Cardiogenic shock	428	9.0 8.2–9.9ROR 9.1 · calibrated p 0.045 ✓	8.7 EB05 8.1 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 7.3 · serious PRR 7.2 · 100% clinician	no trial arm names this drug
Suspected suicide	143	9.0 7.6–10.6ROR 9.0 · calibrated p 0.047 ✓	8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=143 · 100% clinician	no trial arm names this drug
Hepatic encephalopathy	276	8.9 7.9–10.0ROR 8.9 · calibrated p 0.048 ✓	8.6 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 8.3 · serious PRR 7.1 · ♀ 31% (drug 67%)	no trial arm names this drug
Poisoning deliberate	267	8.6 7.6–9.7ROR 8.6 · calibrated p 0.053	8.3 EB05 7.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · 100% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Suicidality	3,645	4.44.3–4.5	signal
Extrapyramidal	1,138	3.23.0–3.4	signal
Hypoglycaemia	829	2.52.4–2.7	signal
Depression	2,145	2.22.1–2.3	signal
Arrhythmia / qt	1,460	2.22.1–2.3	signal
Hyponatraemia	600	2.22.0–2.4	signal
Seizure	1,417	2.12.0–2.2	signal
Fall / fracture	2,321	1.81.7–1.9	raised
Anaphylaxis / angioedema	754	1.81.6–1.9	raised
Rhabdomyolysis / myopathy	485	1.81.6–1.9	raised
Gi bleeding	1,089	1.71.6–1.9	raised
Pancreatitis	415	1.51.4–1.7	raised
Kidney injury	2,241	1.41.4–1.5	raised
Liver injury	1,457	1.41.3–1.5	raised
Stroke	1,134	1.31.3–1.4	raised
Anaemia	1,261	1.21.2–1.3	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Propranolol only as a background or rescue medication (NCT00911508); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Off label use (used outside approved label)	7,918	2.7 2.6–2.7ROR 2.9 · calibrated p 0.661	2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 2.1	no trial arm names this drug
Drug ineffective (drug did not work)	5,617	1.2 1.2–1.3ROR 1.3 · calibrated p 0.488	1.2 EB05 1.2 · IC025 +0.3	Reporting / coding artifact	age-adj. PRR 1.5 · serious PRR 1.9	no trial arm names this drug
Nausea	4,552	1.7 1.6–1.7ROR 1.7 · calibrated p 0.793	1.7 EB05 1.6 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 2.0	no trial arm names this drug
Headache	3,962	1.9 1.8–1.9ROR 1.9 · calibrated p 0.892	1.9 EB05 1.8 · IC025 +0.8	Not in label — unassessed	age-adj. PRR 1.6 · serious PRR 2.3	no trial arm names this drug
Fatigue (tiredness)	3,912	1.5 1.4–1.5ROR 1.5 · calibrated p 0.644	1.5 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.6	no trial arm names this drug
Diarrhoea (diarrhea)	3,294	1.5 1.5–1.6ROR 1.5 · calibrated p 0.658	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.5	no trial arm names this drug
Dizziness	3,222	1.9 1.8–2.0ROR 1.9 · calibrated p 0.912	1.9 EB05 1.8 · IC025 +0.9	Not in label — unassessed	age-adj. PRR 1.7 · serious PRR 2.1	no trial arm names this drug
Product use in unapproved indication	3,114	3.8 3.6–3.9ROR 3.9 · calibrated p 0.398	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.4 · serious PRR 4.0	no trial arm names this drug
Vomiting	2,778	1.7 1.7–1.8ROR 1.8 · calibrated p 0.811	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.7	no trial arm names this drug
Dyspnoea (shortness of breath)	2,674	1.4 1.3–1.4ROR 1.4 · calibrated p 0.575	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.3	no trial arm names this drug
Product use issue	2,595	4.1 4.0–4.3ROR 4.2 · calibrated p 0.339	4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.7 · serious PRR 3.5	no trial arm names this drug
Pain	2,424	1.2 1.1–1.2ROR 1.2 · calibrated p 0.412	1.2 EB05 1.1 · IC025 +0.1	Not in label — unassessed	age-adj. PRR 1.2 · serious PRR 1.1	no trial arm names this drug
Toxicity to various agents	2,382	4.2 4.0–4.4ROR 4.3 · calibrated p 0.325	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.6 · serious PRR 3.5 · 93% clinician	no trial arm names this drug
Anxiety	2,283	2.4 2.3–2.4ROR 2.4 · calibrated p 0.858	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.3 · serious PRR 2.4	no trial arm names this drug
Insomnia (trouble sleeping)	2,247	2.5 2.4–2.6ROR 2.5 · calibrated p 0.802	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.7	no trial arm names this drug

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.

Infantile spitting up — n=196, PRR 177.9
Neovascularisation — n=64, PRR 97.4
Amaurosis fugax — n=222, PRR 76.6
Paranasal cyst — n=46, PRR 69.3
Haemangioma — n=348, PRR 51.6
Granuloma skin — n=103, PRR 41.5
Phonophobia — n=48, PRR 34.1
Cerebral artery thrombosis — n=48, PRR 29.9
Hypoglycaemic seizure — n=70, PRR 24.2
Essential tremor — n=81, PRR 22.8

✓ A hand-written Bradford Hill causality assessment exists for this drug: Propranolol (beta-blockers) ↔ Bradycardia / bronchospasm.

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 Propranolol?

In FDA FAERS, the most frequently co-reported reaction terms for Propranolol are nausea, headache, fatigue, diarrhoea, dizziness, vomiting. 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 Propranolol have an FDA boxed warning?

No. The FDA label retrieved for Propranolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Propranolol 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 54dd0fad-64ee-788f-e063-6394a90ac88e, effective 20260622; matched on openfda.generic_name.exact:"PROPRANOLOL")
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, field patient.drug.openfda.generic_name.exact, 1,168 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 PROPRANOLOL, 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.