Atenolol (Atenolol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Most adverse effects have been mild and transient.

The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (U.S. studies) or elicited, e.g., 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 of atenolol and placebo is similar, causal relationship to atenolol is uncertain.

	Volunteered (U.S. Studies)		Total-Volunteered and Elicited (Foreign + U.S. 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

Acute Myocardial Infarction

In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol. Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table.

In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration:

	Conventional Therapy Plus Atenolol (n = 244)		Conventional Therapy Alone (n = 233)
Bradycardia	43	(18%)	24	(10%)
Hypotension	60	(25%)	34	(15%)
Bronchospasm	3	(1.2%)	2	(0.9%)
Heart Failure	46	(19%)	56	(24%)
Heart Block	11	(4.5%)	10	(4.3%)
BBB + Major Axis Deviation	16	(6.6%)	28	(12%)
Supraventricular Tachycardia	28	(11.5%)	45	(19%)
Atrial Fibrillation	12	(5%)	29	(11%)
Atrial Flutter	4	(1.6%)	7	(3%)
Ventricular Tachycardia	39	(16%)	52	(22%)
Cardiac Reinfarction	0	(0%)	6	(2.6%)
Total Cardiac Arrests	4	(1.6%)	16	(6.9%)
Nonfatal Cardiac Arrests	4	(1.6%)	12	(5.1%)
Deaths	7	(2.9%)	16	(6.9%)
Cardiogenic Shock	1	(0.4%)	4	(1.7%)
Development of Ventricular Septal Defect	0	(0%)	2	(0.9%)
Development of Mitral Regurgitation	0	(0%)	2	(0.9%)
Renal Failure	1	(0.4%)	0	(0%)
Pulmonary Emboli	3	(1.2%)	0	(0%)

In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive atenolol treatment, the dosage of intravenous and subsequent oral atenolol was either discontinued or reduced for the following reasons:

	Reasons for Reduced Dosage
	IV Atenolol Reduced Dose (< 5 mg) 1		Oral Partial Dose
Hypotension/Bradycardia	105	(1.3%)	1168	(14.5%)
Cardiogenic Shock	4	(0.04%)	35	(0.44%)
Reinfarction	0	(0%)	5	(0.06%)
Cardiac Arrest	5	(0.06%)	28	(0.34%)
Heart Block (> first degree)	5	(0.06%)	143	(1.7%)
Cardiac Failure	1	(0.01%)	233	(2.9%)
Arrhythmias	3	(0.04%)	22	(0.27%)
Bronchospasm	1	(0.01%)	50	(0.62%)

During postmarketing experience with atenolol, 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. Atenolol, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome and Raynaud’s phenomenon.

POTENTIAL ADVERSE EFFECTS

In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents, and may be considered potential adverse effects of atenolol.

Hematologic

Agranulocytosis.

Allergic

Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.

Central Nervous System

Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short-term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.

Gastrointestinal

Mesenteric arterial thrombosis, ischemic colitis.

Other

Erythematous rash.

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. Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol therapy with subsequent resolution or quiescence of the reaction.

REPORTS OF SUSPECTED ATENOLOL SIDE EFFECTS / ADVERSE REACTIONS

Possible Atenolol side effects / adverse reactions in 58 year old female

Reported by a physician from Brazil on 2011-10-03

Patient: 58 year old female

Reactions: Blood Pressure Increased, Heart Rate Increased, Headache

Suspect drug(s):
Omeprazole
    Dosage: 20 mg, unk

Atenolol
    Dosage: 50 mg, unk

Simvastatin
    Dosage: 20 mg, unk

Losartan Potassium
    Dosage: 50 mg, unk

Losartan Potassium
    Dosage: 50 mg, bid

Other drugs received by patient: Indapamide

Possible Atenolol side effects / adverse reactions in 59 year old male

Reported by a physician from Norway on 2011-10-04

Patient: 59 year old male

Reactions: Agitation, Disseminated Intravascular Coagulation, Pyrexia, Serotonin Syndrome, Headache, Cerebellar Atrophy, Multi-Organ Failure, Myalgia, Fatigue, Neurodegenerative Disorder, Multiple Drug Overdose, Metabolic Acidosis, Cerebral Arteriosclerosis, Toxicity TO Various Agents, Hepatic Steatosis, Hepatic Enzyme Increased, Dysstasia, Intestinal Dilatation, Heart Rate Increased, Depressed Level of Consciousness

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Mirtazapine
    Dosage: 60 mg (60 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Amitriptyline HCL
    Dosage: 125 mg (125 mg, 1 in 1 d),
    Indication: Depression

Atenolol
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Alprazolam; Isosorbide Mononitrate; Bendroflumethiazide

Possible Atenolol side effects / adverse reactions in 70 year old female

Reported by a pharmacist from Italy on 2011-10-05

Patient: 70 year old female

Reactions: Retrograde Amnesia, Agitation, Psychomotor Retardation, Abnormal Behaviour, Disorientation, Sopor, Bradyphrenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Fexofenadine HCL
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-05-03

Ramipril
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-05-03

Paroxetine HCL
    Administration route: Oral
    Start date: 2011-04-23
    End date: 2011-05-03

Vytorin
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-05-03

Atenolol
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-05-03

Delorazepam
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-05-03