Drug · FAERS side-effect profile with label screen
Atenolol side effects: what 132,467 FDA adverse event reports show
Who reports
132,467 reports · 70% serious · 11,274 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol.
FDA label, Indications and Usage
What it is
Atenolol is an ethanolamine compound having a (4-carbamoylmethylphenoxy)methyl group at the 1-position and an N-isopropyl substituent. It has a role as a beta-adrenergic antagonist, an antihypertensive agent, a xenobiotic, an anti-arrhythmia drug, a sympatholytic agent and an environmental contaminant.
PubChem CID 2249 (ChEBI)
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 3Labeled (related wording) 3Likely indication confounding 10Lab value / disease marker 4Not in label — unassessed 20
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.
- 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.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Electric shock | 124 | 27.0 22.3–32.7ROR 27.0 · calibrated p 5e-4 ✓ | 23.1 EB05 19.9 · IC025 +4.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=120 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Granuloma skin | 111 | 24.4 19.9–29.8ROR 24.4 · calibrated p 9e-4 ✓ | 21.1 EB05 18.0 · IC025 +4.0 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=110 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 112 | 12.8 10.5–15.5ROR 12.8 · calibrated p 0.014 ✓ | 11.8 EB05 10.0 · IC025 +3.2 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Lab value / disease marker | serious n=112 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 179 | 12.0 10.3–13.9ROR 12.0 · calibrated p 0.017 ✓ | 11.1 EB05 9.8 · IC025 +3.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 14.5 (11.6–18.1) | Not in label — unassessed | serious n=179 | not reported in cached trials |
| Intervertebral discitis | 132 | 11.8 9.9–14.1ROR 11.8 · calibrated p 0.019 ✓ | 10.9 EB05 9.4 · IC025 +3.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=132 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 314 | 11.3 10.1–12.7ROR 11.4 · calibrated p 0.021 ✓ | 10.6 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.6 (9.9–13.6) | Not in label — unassessed | serious n=314 | not reported in cached trials |
| Sinus bradycardia | 518 | 8.9 8.1–9.7ROR 8.9 · calibrated p 0.048 ✓ | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 31.7 (26.7–37.6) | Labeled adverse reaction exact term | age-adj. PRR 6.7 · serious PRR 7.1 · 92% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 116 | 8.3 6.8–9.9ROR 8.3 · calibrated p 0.062 | 7.7 EB05 6.6 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Lab value / disease marker | serious n=114 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Atrioventricular block first degree | 214 | 8.1 7.1–9.3ROR 8.1 · calibrated p 0.064 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 62.6 (44.2–88.7) | Not in label — unassessed | serious n=211 · 100% clinician | not reported in cached trials |
| Panniculitis | 115 | 7.9 6.5–9.5ROR 7.9 · calibrated p 0.072 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=114 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Blood pressure inadequately controlled | 278 | 7.6 6.7–8.5ROR 7.6 · calibrated p 0.079 | 7.2 EB05 6.5 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 17.7 (14.6–21.4) | Labeled (related wording) related wording | serious n=233 | not reported in cached trials |
| Diabetic neuropathy | 228 | 7.6 6.6–8.6ROR 7.6 · calibrated p 0.080 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=218 | not reported in cached trials |
| Rebound acid hypersecretion | 137 | 7.4 6.2–8.7ROR 7.4 · calibrated p 0.087 | 6.9 EB05 6.0 · IC025 +2.5 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 18.5 (14.1–24.4) | Not in label — unassessed | serious n=137 | not reported in cached trials |
| Angina unstable | 288 | 7.2 6.4–8.1ROR 7.2 · calibrated p 0.091 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 70.9 (51.6–97.3) | Not in label — unassessed | serious n=287 · ♀ 39% (drug 60%) | not reported in cached trials |
| Rheumatoid nodule | 121 | 7.1 6.0–8.6ROR 7.2 · calibrated p 0.095 | 6.7 EB05 5.8 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=118 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Essential hypertension | 111 | 7.0 5.8–8.5ROR 7.0 · calibrated p 0.100 | 6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 46.2 (30.2–70.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=99 | not reported in cached trials |
| Ventricular hypertrophy | 106 | 6.9 5.7–8.3ROR 6.9 · calibrated p 0.107 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 82.0 (47.0–143.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=105 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Bradycardia (slow heart rate) | 2,220 | 6.9 6.6–7.2ROR 7.0 · calibrated p 0.100 | 6.6 EB05 6.4 · IC025 +2.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 21.7 (20.2–23.3) | Labeled adverse reaction exact term | age-adj. PRR 5.4 · serious PRR 5.5 · 91% clinician | NCT00246519: 4/382 (1.0%) on Atenolol |
| Renal failure chronic | 299 | 6.3 5.6–7.0ROR 6.3 · calibrated p 0.134 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 104.4 (72.2–151.1) | Labeled (related wording) related wording | serious PRR 5.0 | not reported in cached trials |
| Demyelination | 157 | 6.2 5.3–7.3ROR 6.2 · calibrated p 0.138 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=157 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Carotid artery stenosis | 127 | 5.9 4.9–7.1ROR 5.9 · calibrated p 0.159 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 30.6 (21.8–42.9) | Not in label — unassessed | serious n=125 · 100% clinician | not reported in cached trials |
| Left ventricular hypertrophy | 155 | 5.9 5.0–6.9ROR 5.9 · calibrated p 0.159 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 32.3 (23.6–44.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=150 | not reported in cached trials |
| Blood pressure systolic abnormal | 90 | 5.9 4.8–7.3ROR 5.9 · calibrated p 0.161 | 5.6 EB05 4.7 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Likely indication confounding term in indications | serious n=89 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Angioneurotic oedema | 97 | 5.9 4.8–7.2ROR 5.9 · calibrated p 0.163 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=90 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Difficulty in walking | 125 | 5.8 4.9–7.0ROR 5.8 · calibrated p 0.163 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=112 · 100% clinician | not reported in cached trials |
| Blood chloride decreased | 93 | 5.8 4.7–7.2ROR 5.8 · calibrated p 0.165 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Lab value / disease marker | serious n=91 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Coronary artery occlusion | 487 | 5.8 5.3–6.3ROR 5.8 · calibrated p 0.166 | 5.6 EB05 5.2 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 47.5 (38.7–58.4) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.6 | not reported in cached trials |
| Coronary artery disease | 1,053 | 5.6 5.3–6.0ROR 5.7 · calibrated p 0.174 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 40.4 (35.5–46.1) | Labeled adverse reaction exact term | serious PRR 4.5 | not reported in cached trials |
| Coronary artery stenosis | 174 | 5.6 4.8–6.5ROR 5.6 · calibrated p 0.179 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 20.0 (15.6–25.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=174 · ♀ 35% (drug 60%) · 100% clinician | not reported in cached trials |
| Blood pressure diastolic decreased | 255 | 5.6 4.9–6.3ROR 5.6 · calibrated p 0.179 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Likely indication confounding term in indications; also in warnings | serious PRR 4.5 | not reported in cached trials |
| Renal failure acute | 1,472 | 5.6 5.3–5.9ROR 5.6 · calibrated p 0.177 | 5.4 EB05 5.2 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 48.4 (43.0–54.6) | Labeled (related wording) related wording | age-adj. PRR 4.2 · serious PRR 4.5 | not reported in cached trials |
| Fibrosis | 105 | 5.6 4.6–6.8ROR 5.6 · calibrated p 0.186 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=103 · ♀ 100% (drug 60%) | not reported in cached trials |
| High density lipoprotein decreased | 113 | 5.5 4.6–6.6ROR 5.5 · calibrated p 0.189 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Lab value / disease marker | serious n=77 · ♀ 0% (drug 60%) | not reported in cached trials |
| Hyperlipidaemia | 399 | 5.4 4.9–6.0ROR 5.4 · calibrated p 0.194 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 38.9 (31.5–48.0) | Likely indication confounding term in indications | serious PRR 4.5 | not reported in cached trials |
| Dyslipidaemia | 169 | 5.4 4.6–6.3ROR 5.4 · calibrated p 0.196 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 39.8 (28.7–55.1) | Not in label — unassessed | serious n=164 | not reported in cached trials |
| Drug tolerance decreased | 92 | 5.3 4.3–6.6ROR 5.3 · calibrated p 0.205 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=89 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Breath sounds abnormal | 159 | 5.2 4.5–6.1ROR 5.2 · calibrated p 0.212 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 156.5 (85.0–288.3) | Not in label — unassessed | serious n=153 · ♀ 100% (drug 60%) | not reported in cached trials |
| Diverticulum | 231 | 5.2 4.6–5.9ROR 5.2 · calibrated p 0.214 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 37.3 (28.4–49.0) | Not in label — unassessed | serious n=227 | not reported in cached trials |
| Loss of employment | 97 | 5.2 4.2–6.3ROR 5.2 · calibrated p 0.221 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Not in label — unassessed | serious n=96 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Ischaemic cardiomyopathy | 98 | 5.1 4.2–6.3ROR 5.1 · calibrated p 0.224 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other beta-Adrenergic Blockers: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=98 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
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 |
|---|---|---|---|
| Hyponatraemia | 1,684 | 3.43.2–3.5 | signal |
| Arrhythmia / qt | 3,425 | 2.82.7–2.9 | signal |
| Kidney injury | 7,934 | 2.82.7–2.8 | signal |
| Rhabdomyolysis / myopathy | 1,369 | 2.72.6–2.8 | signal |
| Myocardial infarction | 3,357 | 2.62.5–2.7 | signal |
| Heart failure | 2,644 | 2.42.3–2.5 | signal |
| Gi bleeding | 2,648 | 2.32.2–2.4 | signal |
| Hypoglycaemia | 1,345 | 2.22.1–2.4 | signal |
| Hyperglycaemia / diabetes | 4,620 | 2.12.1–2.2 | signal |
| Fall / fracture | 5,042 | 2.12.1–2.2 | signal |
| Anaemia | 3,906 | 2.12.0–2.1 | signal |
| Pancreatitis | 1,049 | 2.12.0–2.2 | raised |
| Stroke | 3,108 | 2.01.9–2.1 | raised |
| Depression | 3,158 | 1.81.7–1.8 | raised |
| Suicidality | 2,580 | 1.71.6–1.7 | raised |
| Tendon disorder | 398 | 1.71.5–1.8 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Atenolol 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 (1 of 40 signal terms matched).
- NCT00246519 — Pharmacogenomic Evaluation of Antihypertensive Responses (N=1701, PHASE4; 16 AE terms posted; arms: Atenolol +HCTZ Arm; HCTZ + Atenolol)
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) | 8,012 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.281 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other beta-Adrenergic Blockers: PRR 19.1 (18.4–19.7) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.2 | not reported in cached trials |
| Nausea | 7,892 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.723 | 1.6 EB05 1.6 · IC025 +0.6 vs other beta-Adrenergic Blockers: PRR 24.9 (23.9–25.8) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT00246519: 3/382 (0.8%) on Atenolol |
| Fatigue (tiredness) | 7,656 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.706 | 1.6 EB05 1.5 · IC025 +0.6 vs other beta-Adrenergic Blockers: PRR 23.4 (22.5–24.3) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT00246519: 25/382 (6.5%) on Atenolol |
| Diarrhoea (diarrhea) | 7,095 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.828 | 1.7 EB05 1.7 · IC025 +0.8 vs other beta-Adrenergic Blockers: PRR 22.2 (21.4–23.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00246519: 2/382 (0.5%) on Atenolol |
| Dyspnoea (shortness of breath) | 6,352 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.845 | 1.8 EB05 1.7 · IC025 +0.8 vs other beta-Adrenergic Blockers: PRR 20.6 (19.8–21.4) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00246519: 2/382 (0.5%) on Atenolol |
| Dizziness | 6,301 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.980 | 2.0 EB05 2.0 · IC025 +1.0 vs other beta-Adrenergic Blockers: PRR 25.8 (24.7–27.0) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | NCT00246519: 13/382 (3.4%) on Atenolol |
| Headache | 5,959 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.665 | 1.5 EB05 1.5 · IC025 +0.5 vs other beta-Adrenergic Blockers: PRR 21.3 (20.4–22.2) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00246519: 35/382 (9.2%) on Atenolol |
| Pain | 5,724 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.640 | 1.5 EB05 1.4 · IC025 +0.5 vs other beta-Adrenergic Blockers: PRR 29.9 (28.5–31.4) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.4 | NCT00246519: 2/382 (0.5%) on Atenolol (serious AE) |
| Asthenia (weakness) | 4,994 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.971 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 25.0 (23.8–26.3) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 2.0 | not reported in cached trials |
| Fall | 4,697 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.903 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 24.0 (22.8–25.2) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 2.0 | not reported in cached trials |
| Arthralgia (joint pain) | 4,655 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.839 | 1.8 EB05 1.7 · IC025 +0.8 vs other beta-Adrenergic Blockers: PRR 33.6 (31.7–35.5) | Not in label — unassessed | age-adj. PRR 1.6 · serious PRR 2.0 | not reported in cached trials |
| Malaise (feeling unwell) | 4,294 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.687 | 1.5 EB05 1.5 · IC025 +0.6 vs other beta-Adrenergic Blockers: PRR 23.6 (22.4–24.9) | Not in label — unassessed | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Vomiting | 4,215 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.602 | 1.4 EB05 1.4 · IC025 +0.5 vs other beta-Adrenergic Blockers: PRR 27.7 (26.2–29.2) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.4 | not reported in cached trials |
| Hypertension (high blood pressure) | 4,111 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.571 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 21.0 (20.0–22.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.7 · serious PRR 2.7 | not reported in cached trials |
| Off label use (used outside approved label) | 4,055 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.146 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other beta-Adrenergic Blockers: PRR 13.9 (13.3–14.5) | Reporting / coding artifact | age-adj. PRR 0.7 · serious PRR 0.7 | 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.
- Electric shock — n=124, PRR 27.0
- Granuloma skin — n=111, PRR 24.4
- Hyperparathyroidism secondary — n=179, PRR 12.0
- Intervertebral discitis — n=132, PRR 11.8
- Nephrogenic anaemia — n=314, PRR 11.3
- Atrioventricular block first degree — n=214, PRR 8.1
- Panniculitis — n=115, PRR 7.9
- Rebound acid hypersecretion — n=137, PRR 7.4
- Angina unstable — n=288, PRR 7.2
- Rheumatoid nodule — n=121, PRR 7.1
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 Atenolol?
In FDA FAERS, the most frequently co-reported reaction terms for Atenolol are nausea, fatigue, diarrhoea, dyspnoea, 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 Atenolol have an FDA boxed warning?
No. The FDA label retrieved for Atenolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atenolol 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 0fadc652-b075-46ec-ae05-beaf7d91ae13, effective 20260720; matched on
openfda.generic_name.exact:"ATENOLOL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 2249 description (ChEBI)
- 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
ATENOLOL, 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.