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.
|
