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Atenolol and Chlorthalidone (Atenolol / Chlorthalidone) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Atenolol and chlorthalidone tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for atenolol and chlorthalidone 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, 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 for atenolol and placebo is similar, causal relationship to atenolol is uncertain.

VolunteeredTotal–Volunteered and Elicited
(US Studies)(Foreign + US Studies)
AtenololPlaceboAtenololPlacebo
(n=164)(n=206)(n=399)(n=407)
%%%%
CARDIOVASCULAR
    Bradycardia3030
    Cold Extremities00.5125
    Postural Hypotension2145
    Leg Pain00.531
CENTRAL NERVOUS SYSTEM/
NEUROMUSCULAR
    Dizziness41136
    Vertigo20.520.2
    Light-Headedness1030.7
    Tiredness0.60.52613
    Fatigue3165
    Lethargy1030.7
    Drowsiness0.6020.5
    Depression0.60.5129
    Dreaming0031
GASTROINTESTINAL
    Diarrhea2032
    Nausea4131
RESPIRATORY (see WARNINGS )
    Wheeziness0033
    Dyspnea0.6164

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. Atenolol, 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 atenolol and chlorthalidone conducted in the United States (89 patients treated with atenolol and chlorthalidone) 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, and 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. 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.

Clinical Laboratory Test Findings

Clinically important changes in standard laboratory parameters were rarely associated with the administration of atenolol and chlorthalidone. 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.



REPORTS OF SUSPECTED ATENOLOL AND CHLORTHALIDONE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Atenolol and Chlorthalidone. The information is not vetted and should not be considered as verified clinical evidence.

Possible Atenolol and Chlorthalidone side effects / adverse reactions in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-10-06

Patient: 80 year old male

Reactions: Dermatitis, Skin Lesion, Rash Maculo-Papular, Toxic Skin Eruption, Prurigo

Adverse event resulted in: hospitalization

Suspect drug(s):
Atenolol and Chlorthalidone
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2009-11-01

Metformin HCL
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2009-11-01

Other drugs received by patient: Sintrom



Possible Atenolol and Chlorthalidone side effects / adverse reactions in 54 year old female

Reported by a physician from Brazil on 2011-11-08

Patient: 54 year old female

Reactions: Dyslipidaemia, Chest Pain, Blood Pressure Inadequately Controlled, Coronary Artery Disease, Hypertension, Electrocardiogram ST Segment Elevation, Metabolic Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Olmesartan Medoxomil
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Hypertension

Amlodipine Besylate
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Hypertension

Atenolol
    Dosage: 25 mg, unk
    Administration route: Oral

Atenolol and Chlorthalidone
    Dosage: 50/12.5 mg, unk
    Administration route: Oral
    Indication: Hypertension

Rosuvastatin
    Dosage: 10 mg, unk
    Administration route: Oral

Other drugs received by patient: Aspirin; Diovan; Clopidogrel



Possible Atenolol and Chlorthalidone side effects / adverse reactions in 54 year old female

Reported by a physician from Brazil on 2011-11-15

Patient: 54 year old female

Reactions: Blood Pressure Inadequately Controlled, Cardiac Stress Test Abnormal, Chest Pain, Coronary Artery Disease, Metabolic Disorder, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Suspect drug(s):
Amlodipine
    Dosage: 5 mg (5 mg), per oral
    Administration route: Oral
    Indication: Hypertension

Olmesartan Medoxomil
    Dosage: 20 mg (20 mg), per oral
    Administration route: Oral
    Indication: Hypertension

Atenolol
    Dosage: 25 mg, per oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Atenolol and Chlorthalidone
    Dosage: 50/12.5 mg, per oral
    Indication: Hypertension

Rosuvastatin
    Dosage: 10 mg (10 mg), per oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: ASA (Acetylsalicylic Acid) (Acetylsalicylic Acid); Clopidogrel (Clopidogrel) (Clopidogrel); Diovan



See index of all Atenolol and Chlorthalidone side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-30

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