Side Effects of Sectral (acebutolol)

Sectral (acebutolol) is a beta-blocker used alone or with other drugs to treat high blood pressure and arrhythmias. It is also used to treat chest pain due to coronary artery disease (angina) in which the supply of blood and oxygen to the heart are inadequate for the heart to pump normally. 

Common side effects of Sectral include:

• dizziness,
• lightheadedness,
• excessive tiredness,
• headache,
• constipation,
• diarrhea,
• upset stomach, and
• muscle aches.

Serious side effects of Sectral include:

• heart failure,
• slow heart rate,
• heart block,
• heart attack,
• abnormal heartbeats,
• Raynaud’s phenomenon,
• lupus erythematous,
• shortness of breath or wheezing,
• swelling of the feet and lower legs, and
• chest pain.

Drug interactions of Sectral include fenoldopam because it may result in unexpectedly low blood pressure.

Concomitant use of clonidine and Sectral may result in severe high blood pressure if patients abruptly discontinue the clonidine.

Using epinephrine and beta-adrenergic blocking drugs together causes high blood pressure.

Epinephrine- and norepinephrine-depleting drugs, such as reserpine may have an additive effect when given with beta-blocking drugs and cause an abnormally slow heartbeat or low blood pressure, which may give rise to dizziness or fainting.

There are no adequate studies of Sectral in pregnant women. Sectral should be used during pregnancy only if the potential benefit justifies the risk to the fetus Sectral passes into breast milk, and use among breastfeeding mothers is discouraged.

Most adverse reactions to Sectral have been mild, not required discontinuation of therapy, and tended to decrease as the duration of treatment increases. Adverse events include:

• Dizziness
• Lightheadedness
• Excessive tiredness
• Headache
• Constipation
• Diarrhea
• Upset stomach
• Muscle aches

Possible serious side effects include:

• Heart failure
• Slow heart rate
• Heart block
• Heart attack
• Abnormal heart beats
• Raynaud phenomenon
• Lupus erythematous

With serious adverse events such as shortness of breath or wheezing, swelling of the feet and lower legs and chest pain, it is advisable to contact a doctor immediately.

Sectral 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 Sectral, propranolol, or hydrochlorothiazide as monotherapy, or placebo.

TOTAL VOLUNTEERED AND ELICITED (U.S. STUDIES)

The following selected (potentially important) side effects were seen in up to 2% of Sectral 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 Sectral dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)

Potential Adverse Events

In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Sectral.

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 β-blocker practolol has not been reported with Sectral during investigational use and extensive foreign clinical experience.

• Catecholamine-depleting drugs, such as reserpine, may have an additive effect when given with β- blocking agents.
• Patients treated with Sectral plus catecholamine depletors should, therefore, be observed closely for evidence of marked bradycardia or hypotension which may present as vertigo, syncope/presyncope, or orthostatic changes in blood pressure without compensatory tachycardia.
• Exaggerated hypertensive responses have been reported from the combined use of β-adrenergic antagonists and α-adrenergic stimulants, including those contained in proprietary cold remedies and vasoconstrictive nasal drops.
• Patients receiving β-blockers should be warned of this potential hazard.
• Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.
• No significant interactions with digoxin, hydrochlorothiazide, hydralazine, sulfinpyrazone, oral contraceptives, tolbutamide, or warfarin have been observed.
• Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.