FDA label 0872728d-4d39-4413-a179-ac074dcbbde3

openFDA label record#

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SPL set ID
0ebcca1e-ca16-4483-429a-aec5dcacd1dc
SPL ID
0872728d-4d39-4413-a179-ac074dcbbde3
Version
10
Effective date
2017-01-18
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:20

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. IN PATIENTS WITHOUT A HISTORY OF CARDIAC FAILURE, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, TENORETIC should be withdrawn. (See DOSAGE AND ADMINISTRATION .) Renal and Hepatic Disease and Electrolyte Disturbances Since atenolol is excreted via the kidneys, TENORETIC should be used with caution in patients with impaired renal function. In patients with renal disease, thiazides may precipitate azotemia. Since cumulative effects may develop in the presence of impaired renal function, if progressive renal impairment becomes evident, TENORETIC should be discontinued. In patients with impaired hepatic function or progressive liver disease, minor alterations in fluid and electrolyte balance may precipitate hepatic coma. TENORETIC should be used with caution in these patients. Ischemic Heart Disease Following abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported. Therefore, such patients should be cautioned against interruption of therapy without the physician's advice. Even in the absence of overt angina pectoris, when discontinuation of TENORETIC is planned, the patient should be carefully observed and should be advised to limit physical activity to a minimum. TENORETIC should be reinstated if withdrawal symptoms occur. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TENORETIC therapy abruptly even in patients treated only for hypertension. Concomitant Use of Calcium Channel Blockers Bradycardia and heart block can occur and the left ventricular end diastolic pressure can rise when beta-blockers are administered with verapamil or diltiazem. Patients with pre-existing conduction abnormalities or left ventricular dysfunction are particularly susceptible. (See PRECAUTIONS .) Bronchospastic Diseases PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Because of its relative beta 1 -selectivity, however, TENORETIC may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate, other antihypertensive treatment. Since beta 1 -selectivity is not absolute, the lowest possible dose of TENORETIC should be used and a beta 2 -stimulating agent (bronchodilator) should be made available. If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Metabolic and Endocrine Effects TENORETIC may be used with caution in diabetic patients. Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. At recommended doses atenolol does not potentiate insulin-induced hypoglycemia and, unlike nonselective beta blockers, does not delay recovery of blood glucose to normal levels. Insulin requirements in diabetic patients may be increased, decreased or unchanged; latent diabetes mellitus may become manifest during chlorthalidone administration. Beta-adrenergic blockade may mask certain clinical signs (eg, tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom TENORETIC therapy is to be withdrawn should be monitored closely. Because calcium excretion is decreased by thiazides, TENORETIC should be discontinued before carrying out tests for parathyroid function. Pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy; however, the common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen. Hyperuricemia may occur, or acute gout may be precipitated in certain patients receiving thiazide therapy. Untreated Pheochromocytoma TENORETIC should not be given to patients with untreated pheochromocytoma.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS TENORETIC is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for TENORETIC are essentially the same as those seen with the individual components. Atenolol The frequency estimates in the following table were derived from controlled studies in which adverse reactions were either volunteered by the patient (US studies) or elicited, eg, by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects for atenolol and placebo is similar, causal relationship to atenolol is uncertain. Volunteered (US Studies) Total − Volunteered and Elicited (Foreign + US Studies) Atenolol (n=164) % Placebo (n=206) % Atenolol (n=399) % Placebo (n=407) % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2 0.2 Light-headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fatigue 3 1 6 5 Lethargy 1 0 3 0.7 Drowsiness 0.6 0 2 0.5 Depression 0.6 0.5 12 9 Dreaming 0 0 3 1 GASTROINTESTINAL Diarrhea 2 0 3 2 Nausea 4 1 3 1 RESPIRATORY (see WARNINGS ) Wheeziness 0 0 3 3 Dyspnea 0.6 1 6 4 During postmarketing experience, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie's disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. TENORETIC, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud’s phenomenon. Chlorthalidone Cardiovascular: orthostatic hypotension; Gastrointestinal: anorexia, gastric irritation, vomiting, cramping, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis; CNS: vertigo, paresthesia, xanthopsia; Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia; Hypersensitivity: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis), Lyell's syndrome (toxic epidermal necrolysis); Miscellaneous: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness. Clinical trials of TENORETIC conducted in the United States (89 patients treated with TENORETIC) revealed no new or unexpected adverse effects. POTENTIAL ADVERSE EFFECTS In addition, a variety of adverse effects not observed in clinical trials with atenolol but reported with other beta-adrenergic blocking agents should be considered potential adverse effects of atenolol. Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, decreased performance on neuropsychometrics; Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS ); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress. Miscellaneous There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and, in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy. (See DOSAGE AND ADMINISTRATION .) The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with atenolol (TENORMIN). Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol (TENORMIN) therapy with subsequent resolution or quiescence of the reaction. Clinical Laboratory Test Findings Clinically important changes in standard laboratory parameters were rarely associated with the administration of TENORETIC. The changes in laboratory parameters were not progressive and usually were not associated with clinical manifestations. The most common changes were increases in uric acid and decreases in serum potassium.

adverse reactions table

<table width="100%"> <col width="36%"/> <col width="10%"/> <col width="10%"/> <col width="12%"/> <col width="12%"/> <tbody> <tr> <td valign="top"/> <td align="center" colspan="2" valign="top"> <paragraph>Volunteered</paragraph> <paragraph> <content styleCode="underline">(US Studies)</content> </paragraph> </td> <td align="center" colspan="2" valign="top"> <paragraph>Total &#x2212; Volunteered</paragraph> <paragraph>and Elicited</paragraph> <paragraph> <content styleCode="underline">(Foreign + US Studies)</content> </paragraph> </td> </tr> <tr> <td valign="top"/> <td valign="top"> <paragraph>Atenolol</paragraph> <paragraph>(n=164)</paragraph> <paragraph>%</paragraph> </td> <td align="center" valign="top"> <paragraph>Placebo</paragraph> <paragraph>(n=206)</paragraph> <paragraph>%</paragraph> </td> <td valign="top"> <paragraph>Atenolol</paragraph> <paragraph>(n=399)</paragraph> <paragraph>%</paragraph> </td> <td valign="top"> <paragraph>Placebo</paragraph> <paragraph>(n=407)</paragraph> <paragraph>%</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>CARDIOVASCULAR</paragraph> </td> <td colspan="4" valign="top"/> </tr> <tr> <td valign="top"> <paragraph> Bradycardia</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Cold Extremities</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" valign="top"> <paragraph>12</paragraph> </td> <td align="center" valign="top"> <paragraph>5</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Postural Hypotension</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>4</paragraph> </td> <td align="center" valign="top"> <paragraph>5</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Leg Pain</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>CENTRAL NERVOUS SYSTEM/</paragraph> <paragraph>NEUROMUSCULAR</paragraph> </td> <td colspan="4" valign="top"/> </tr> <tr> <td valign="top"> <paragraph> Dizziness</paragraph> </td> <td align="center" valign="top"> <paragraph>4</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>13</paragraph> </td> <td align="center" valign="top"> <paragraph>6</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Vertigo</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> <td align="center" valign="top"> <paragraph>0.2</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Light-headedness</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Tiredness</paragraph> </td> <td align="center" valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" valign="top"> <paragraph>26</paragraph> </td> <td align="center" valign="top"> <paragraph>13</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Fatigue</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>6</paragraph> </td> <td align="center" valign="top"> <paragraph>5</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Lethargy</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Drowsiness</paragraph> </td> <td align="center" valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Depression</paragraph> </td> <td align="center" valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" valign="top"> <paragraph>0.5</paragraph> </td> <td align="center" valign="top"> <paragraph>12</paragraph> </td> <td align="center" valign="top"> <paragraph>9</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Dreaming</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>GASTROINTESTINAL</paragraph> </td> <td colspan="4" valign="top"/> </tr> <tr> <td valign="top"> <paragraph> Diarrhea</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>2</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Nausea</paragraph> </td> <td align="center" valign="top"> <paragraph>4</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph>RESPIRATORY (see <linkHtml href="#powellk11152631021046">WARNINGS</linkHtml>)</paragraph> </td> <td colspan="4" valign="top"/> </tr> <tr> <td valign="top"> <paragraph> Wheeziness</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> <td align="center" valign="top"> <paragraph>3</paragraph> </td> </tr> <tr> <td valign="top"> <paragraph> Dyspnea</paragraph> </td> <td align="center" valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" valign="top"> <paragraph>1</paragraph> </td> <td align="center" valign="top"> <paragraph>6</paragraph> </td> <td align="center" valign="top"> <paragraph>4</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.