Tenormin (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 (US studies) or elicited, eg, by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both TENORMIN and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of TENORMIN and placebo is similar, causal relationship to TENORMIN 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

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		Conventional Therapy Alone
	(n=244)		(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 TENORMIN treatment, the dosage of intravenous and subsequent oral TENORMIN 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	(.04%)	35	(.44%)
Reinfarction	0	(0%)	5	(.06%)
Cardiac Arrest	5	(.06%)	28	(.34%)
Heart Block (> first degree)	5	(.06%)	143	(1.7%)
Cardiac Failure	1	(.01%)	233	(2.9%)
Arrhythmias	3	(.04%)	22	(.27%)
Bronchospasm	1	(.01%)	50	(.62%)

During postmarketing experience with TENORMIN, 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. TENORMIN, 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 TENORMIN.

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

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO TENORMIN

Possible Tenormin side effects / adverse reactions in 57 year old male

Reported by a pharmacist from Japan on 2007-10-02

Patient: 57 year old male weighing 59.0 kg (129.8 pounds)

Reactions: White Blood Cell Count Decreased, Dyspnoea, Pericardial Effusion, Haemoglobin Decreased, Haematocrit Decreased, Thrombocytopenic Purpura, Platelet Count Decreased, Haemorrhagic Diathesis, Rash Maculo-Papular

Adverse event resulted in: life threatening event

Suspect drug(s):
Aldactone
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2007-06-27
    End date: 2007-07-20

Amlodipine Besylate
    Indication: Angina Pectoris
    Start date: 2004-04-01

Aspirin
    Dosage: 100mg
    Administration route: Oral
    End date: 2007-07-12

Bepricor
    Dosage: 150 mg/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2007-07-02
    End date: 2007-07-20

Lasix
    Dosage: 20 mg/day
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2007-06-12
    End date: 2007-07-13

Micardis
    Dosage: 20 mg/day
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2004-04-01
    End date: 2007-07-20

Mucosta
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: Gastric Mucosal Lesion
    Start date: 2007-05-18
    End date: 2007-07-13

Nitroderm
    Dosage: 1 patch/day
    Indication: Angina Pectoris
    Start date: 2007-07-13

Propylthiouracil
    Dosage: 300 mg/day
    Administration route: Oral
    Start date: 1987-01-01
    End date: 2007-07-12

Propylthiouracil
    Dosage: 200 mg/day
    Administration route: Oral
    Start date: 2007-07-13
    End date: 2007-07-20

Propylthiouracil
    Dosage: 300 mg/day
    Administration route: Oral
    Start date: 2007-08-03

Sigmart
    Dosage: 15 mg/day
    Administration route: Oral
    Indication: Angina Pectoris
    Start date: 2004-04-01
    End date: 2007-07-13

Tenormin
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2004-04-01
    End date: 2007-07-20

Warfarin Sodium
    Dosage: 3 mg/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2007-06-07
    End date: 2007-07-09

Other drugs received by patient: Unasyn; Gentacin

Possible Tenormin side effects / adverse reactions in 82 year old male

Reported by a physician from Japan on 2009-04-02

Patient: 82 year old male weighing 53.0 kg (116.6 pounds)

Reactions: Hyperkalaemia, Renal Failure Acute, Shock

Adverse event resulted in: life threatening event

Suspect drug(s):
Amlodipine
    Dosage: 1 t (5 mg) each after breakfast and at bedtime from 20-aug-2007
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-03-19

Blopress
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-12-27

Tenormin
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-12-05
    End date: 2006-10-01

Tenormin
    Administration route: Oral
    Start date: 2006-10-02

Other drugs received by patient: Aspirin; Clarith; Levothyroxine Sodium; Depas; Serevent; Omepral Tablets

Possible Tenormin side effects / adverse reactions in 82 year old male

Reported by a physician from Japan on 2009-04-06

Patient: 82 year old male weighing 53.0 kg (116.6 pounds)

Reactions: Vomiting, Hepatic Function Abnormal, Hyperkalaemia, Coagulopathy, Atrial Fibrillation, Bradycardia, Blood Pressure Immeasurable, Renal Failure Acute, Shock

Adverse event resulted in: life threatening event

Suspect drug(s):
Amlodipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-03-19
    End date: 2007-08-19

Amlodipine
    Administration route: Oral
    Start date: 2007-08-20

Blopress
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-12-27

Tenormin
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-01-25
    End date: 2006-10-01

Tenormin
    Administration route: Oral
    Start date: 2006-10-02

Other drugs received by patient: Aspirin; Clarith; Levothyroxine Sodium; Depas; Omepral; Serevent