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Sectral (Acebutolol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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)
Body System/
Adverse Reaction
SECTRAL
(N=1002)
%
Propranolol
(N=424)
%
Hydrochloro-
thiazide
(N=178)
%
Placebo
(N=314)
%
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 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.)

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 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 (see CONTRAINDICATIONS).

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.



REPORTS OF SUSPECTED SECTRAL SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Sectral side effects / adverse reactions in 71 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-20

Patient: 71 year old female

Reactions: Confusional State, Electrocardiogram QRS Complex Prolonged, Diarrhoea, Hyperkalaemia, Dehydration, Lactic Acidosis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Atacand
    Dosage: 16 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-07-21

Glucophage
    Dosage: 850 mg, 3x/day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-07-21

Aldactone
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure
    End date: 2011-07-21

Sectral
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-07-21

Other drugs received by patient: Previscan; Calcium Carbonate; Rabeprazole Sodium; Cordarone; Lasix



Possible Sectral side effects / adverse reactions in female

Reported by a physician from France on 2011-10-24

Patient: female

Reactions: Electrocardiogram QRS Complex Prolonged, Hyperkalaemia, Dehydration, Renal Failure Acute

Adverse event resulted in: life threatening event

Suspect drug(s):
Glucophage
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-07-21

Sectral
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-07-21

Atacand
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-07-21

Aldactone
    Administration route: Oral
    Indication: Cardiac Failure
    End date: 2011-07-21

Other drugs received by patient: Rabeprazole Sodium; Previscan; Lasix; Cordarone; Cacit Vitamine D3



Possible Sectral side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: 49 year old female weighing 82.9 kg (182.4 pounds)

Reactions: Hypothyroidism

Suspect drug(s):
Sectral

Other drugs received by patient: Synthroid; Dyazide; Vivelle-DOT; Prometrium; Cytomel; Synthroid



See index of all Sectral side effect reports >>

Drug label data at the top of this Page last updated: 2012-01-12

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