Atenolol Side Effects: Common, Serious & FDA Warnings
Based on 133,000+ FDA adverse event reports, the most-reported atenolol reactions include nausea, fatigue, and diarrhoea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
Common Side Effects of Atenolol
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for atenolol. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Nausea | 8,217 | 6.2% |
| Fatigue | 7,671 | 5.8% |
| Diarrhoea | 7,109 | 5.3% |
| Dyspnoea | 6,363 | 4.8% |
| Dizziness | 6,327 | 4.7% |
| Headache | 5,988 | 4.5% |
| Pain | 5,728 | 4.3% |
| Asthenia | 5,027 | 3.8% |
| Arthralgia | 4,651 | 3.5% |
| Malaise | 4,308 | 3.2% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
Atenolol Recalls
FDA enforcement actions matched to atenolol via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 3 closed recalls (2014 to 2022)
Includes resolved and terminated recalls matched to atenolol. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-11-02 | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets Golden State Medical Supply Inc. | Class I | 2,584 Bottles | Terminated |
| 2017-03-29 | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. Zydus Pharmaceuticals USA Inc | Class II | 9561 bottles | Terminated |
| 2014-10-15 | Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance. Zydus Pharmaceuticals USA Inc | Class II | 5400 bottles | Terminated |
Atenolol Shortages
FDA-listed shortages of atenolol products. Strength and dosage-form level detail.
Is Atenolol Safe?
Atenolol is FDA-approved and the label does not carry a boxed warning.
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Atenolol is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
INDICATIONS AND USAGE 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. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.Show full Indications and Usage
Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis Atenolol tablets are indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS .) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mmHg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mmHg) seemed less likely to benefit.
Frequently Asked Questions
What are the most-reported side effects of atenolol?
Is atenolol the same as Tenormin?
Has atenolol been recalled?
What do FDA recall classes mean?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.