A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sectral Side Effects, and Drug Interactions - Acebutolol
Sectral Side Effects, and Drug Interactions - Acebutolol
SIDE EFFECTS
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.
|
Total Volunteered And Elicited (U.S. Studies)
|
|
Body System
Adverse Reaction
|
Acebutolol (N= 1002)
|
Propranolol (N= 424)
|
Hydrochlorothiazide
(N= 118)
|
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
|
-
|
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 ot AV block
(see CONTRAINDICATIONS).
Allergic: Erythematous rash,
fever combined with aching and
sore throat,
laryngospasm, and respiratory
distress.
Hematologic: Agranulocytosis, non-thrornbocytopenic, 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.
DRUG INTERACTIONS
Catecholamine-depleting drugs, such as reserpine, may have an additive
effect when given with beta-blocking agents. Patients treated with acebutolol
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 beta-adrenergic
antagonists and alpha-adrenergic stimulants, including those contained
in proprietary cold remedies
and vasoconstrictive nasal drops. Patients receiving beta-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.
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