Sectral Side Effects

Generic Name: acebutolol

Please note - some side effects for Sectral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sectral - for the Consumer

Sectral

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sectral:

Constipation; diarrhea; dizziness or lightheadedness; frequent urination; gas; headache; indigestion; mild drowsiness; nausea; sleepiness; sleeplessness; unusual tiredness or weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; difficulty breathing, especially when lying down; shortness of breath; swelling of ankles.

Side Effects by Body System

General

Acebutolol is generally well tolerated. Most side effects are mild and decrease with treatment.

Cardiovascular

Cases of syncope associated with severe sinus bradycardia and hypotension after a single dose of acebutolol are reported.

Cardiovascular side effects include severe bradycardia (less than 48 bpm) in up to 1% of patients. Chest pain and edema have been reported in 3% to 6% of patients. Patients with a history of heart block may develop heart block or worsened heart block after acebutolol administration. As with other beta-blockers, acebutolol may worsen congestive heart failure.

Nervous system

A case of myasthenia with antistriated muscle antibodies and acetylcholine receptor antibodies has been associated with acebutolol. Some beta-blockers may cause mental status changes (particularly depression), but this is rarely reported with acebutolol.

Nervous system side effects are usually general and vague. Fatigue and headache are reported in up to 13% of patients. Other neurologic side effects include dizziness, insomnia, somnolence, depression, paresthesias, and dreams in less than 5% of patients. Impotence is reported in less than 2% of men.

Gastrointestinal

Gastrointestinal side effects include nausea, diarrhea, dyspepsia, flatulence, or constipation in 5% to 8% of patients.

Immunologic

Immunologic side effects of acebutolol are reported in rare cases. Symptoms include arthralgias, myalgias, joint swelling, and rash, and may be associated with the development of antinuclear antibodies and a lupus syndrome.

Hypersensitivity

Hypersensitivity to acebutolol is rare. Urticarial rash, six cases of hypersensitivity hepatitis, and a case of lymphocytic pneumonitis are reported.

Hepatic

In all six cases except one, affected patients were taking 400 mg per day, and developed symptoms such as fever, nausea, dark urine, and headache after a mean duration of 22 days. All patients fully recovered after acebutolol was withheld; two were rechallenged with recurrent reversible hepatitis. A hypersensitivity mechanism was suspected.

Hepatic toxicity has been reported in only 6 cases of 1.6 million outpatient prescriptions of acebutolol.

Respiratory

A case of pleural thickening due to fibrotic pulmonary granulomas is reported. Hypersensitivity pneumonitis is reported in rare cases.

Respiratory side effects are rare. Dyspnea and rhinitis are reported in 4% and 2% of patients respectively. Pharyngitis, wheezing, and cough are reported in less than 2% of patients.

Dermatologic

Dermatologic side effects are rare. A case of lichen planus with skin biopsy findings consistent with lupus erythematosus and chronic dermatitis associated with acebutolol has been reported.

Metabolic

Metabolic changes are usually insignificant. Unlike some beta-blockers, acebutolol has not been associated with hypercholesterolemia or hypertriglyceridemia.

After two months, mild decreases in HDL cholesterol may be seen, but no significant changes have been observed after six months of therapy.

Genitourinary

The Treatment of Mild Hypertension Study (TOMHS), a randomized, placebo-controlled, double-blind study has shown that there is a slightly and significantly higher incidence of sexual dysfunction (obtaining and maintaining erections) among male patients who are taking acebutolol for 48 months compared with placebo.

Genitourinary problems include increased frequency and erection problems among male patients.

Musculoskeletal

Musculoskeletal side effects including arthralgia and myalgia have been reported.

Other

Other side effects including abnormal vision have been reported rarely.

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