Acebutolol Side Effects
Brand Names: Sectral
Please note - some side effects for Acebutolol 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 Acebutolol - for the Consumer
Acebutolol
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 Acebutolol:
Seek medical attention right away if any of these SEVERE side effects occur when using Acebutolol:Constipation; diarrhea; dizziness or lightheadedness; frequent urination; gas; headache; indigestion; mild drowsiness; nausea; sleepiness; sleeplessness; unusual tiredness or weakness.
TopSevere 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.
Acebutolol Side Effects - for the Professional
Acebutolol
Acebutolol is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases.
The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received Acebutolol, propranolol, or hydrochlorothiazide as monotherapy, or placebo.
| Acebutolol (N=1002) |
PROPRANOLOL (N=424) |
HYDROCHLOROTHIAZIDE (N=178) |
PLACEBO (N=314) |
|
|---|---|---|---|---|
| Body System/ Adverse Reaction |
% | % | % | % |
| Cardiovascular | ||||
| Chest Pain | 2 | 4 | 4 | 1 |
| Edema | 2 | 2 | 4 | 1 |
| Central Nervous System | ||||
| Depression | 2 | 1 | 3 | 1 |
| Dizziness | 6 | 7 | 12 | 2 |
| Fatigue | 11 | 17 | 10 | 4 |
| Headache | 6 | 9 | 13 | 4 |
| Insomnia | 3 | 6 | 5 | 1 |
| Abnormal dreams | 2 | 3 | 0 | 1 |
| Dermatologic | ||||
| Rash | 2 | 2 | 4 | 1 |
| Gastrointestinal | ||||
| Constipation | 4 | 2 | 7 | 0 |
| Diarrhea | 4 | 5 | 5 | 1 |
| Dyspepsia | 4 | 6 | 3 | 1 |
| Flatulence | 3 | 4 | 7 | 1 |
| Nausea | 4 | 6 | 3 | 0 |
| Genitourinary | ||||
| Micturition (frequency) | 3 | 1 | 9 | <1 |
| Musculoskeletal | ||||
| Arthralgia | 2 | 1 | 3 | 2 |
| Myalgia | 2 | 1 | 4 | 0 |
| Respiratory | ||||
| Cough | 1 | 1 | 2 | 0 |
| Dyspnea | 4 | 6 | 4 | 2 |
| Rhinitis | 2 | 1 | 4 | <1 |
| Special Senses | ||||
| Abnormal Vision | 2 | 2 | 3 | 0 |
The following selected (potentially important) side effects were seen in up to 2% of Acebutolol patients:
Cardiovascular: hypotension, bradycardia, heart failure.
Central Nervous System: anxiety, hyper/hypoesthesia, impotence.
Dermatological: pruritus.
Gastrointestinal: vomiting, abdominal pain.
Genitourinary: dysuria, nocturia.
Liver and Biliary System: A small number of cases of liver abnormalities (increased SGOT, SGPT, LDH) have been reported in association with Acebutolol therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise, dark urine, anorexia, nausea, headache, and/or other symptoms have been reported. In some of the reported cases, the symptoms and signs were confirmed by rechallenge with Acebutolol. The abnormalities were reversible upon cessation of Acebutolol therapy.
Musculoskeletal: back pain, joint pain.
Respiratory: pharyngitis, wheezing.
Special Senses: conjunctivitis, dry eye, eye pain.
Autoimmune: In extremely rare instances, systemic lupus erythematosus has been reported.
The incidence of drug-related adverse effects (volunteered and solicited) according to Acebutolol dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)
| Body System | 400 mg/day (N=132) |
800 mg/day (N=63) |
1200 mg/day (N=71) |
|---|---|---|---|
| Cardiovascular | 5% | 2% | 1% |
| Gastrointestinal | 3% | 3% | 7% |
| Musculoskeletal | 2% | 3% | 4% |
| Central Nervous System | 9% | 13% | 17% |
| Respiratory | 1% | 5% | 6% |
| Skin | 1% | 2% | 1% |
| Special Senses | 2% | 2% | 6% |
| Genitourinary | 2% | 3% | 1% |
Potential Adverse Effects
In addition, certain adverse effects not listed above have been reported with other beta-blocking agents and should also be considered as potential adverse effects of Acebutolol.
Central Nervous System: Reversible mental depression progressing to catatonia (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).
Cardiovascular: Intensification of AV block.
Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Hematologic: Agranulocytosis, nonthrombocytopenic, and thrombocytopenic purpura.
Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis.
Miscellaneous: Reversible alopecia and Peyronie's disease. The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with Acebutolol during investigational use and extensive foreign clinical experience.
TopSide 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.
TopMore resources:
Acebutolol - Includes detailed dosage instructions.
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