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Sotalol (Sotalol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral sotalol, of whom 2451 received the drug for at least two weeks. The most important adverse effects are torsade de pointes and other serious new ventricular arrhythmias (see WARNINGS), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of sotalol are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.

Occasional reports of elevated serum liver enzymes have occurred with sotalol therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.

The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1292 patients with sustained VT/VF.

Incidence (%) of Adverse Events and Discontinuations
DAILY DOSE
Body
System 
160 mg
(n=832)
240 mg
(n=263)
320 mg
(n=835)
480 mg
(n=459)
640 mg
(n=324)

Any Dosea
(n=1292)

% Patients
Discontinued
(n=1292)
Body as
a whole
infection <1 
fever <1 
localized pain <1 

Cardiovascular

dyspnea 11  15  15  21 
bradycardia  16 
chest pain 10  10  14  16  <1 
palpitation 12  14  <1 
edema
ECG abnormal   2
hypotension  3
proarrhythmia <1  <1   5
syncope  5
heart failure  2
presyncope  3 <1 
peripheral vascular
   disorder
2 <1 
cardiovascular
   disorder
<1   2 <1 
vasodilation <1   1 <1 
AICD discharge <1   2 <1 
hypertension <1  <1 

Nervous

fatigue 12  12  13  20  2
dizziness 11  11  14  20   1
asthenia 10  13   1
light-headed 12   1
headache  <1
sleep problem  <1
perspiration  <1
altered
   consciousness
 <1
depression  <1
paresthesia  <1
anxiety  <1
mood change <1  <1   <1
appetite disorder  <1
stroke <1  <1  <1   <1

Digestive

nausea/vomiting 10   1
diarrhea  <1
dyspepsia  <1
abdominal pain <1  <1  2  <1
colon problem <1   <1
flatulence <1   <1

Respiratory

pulmonary problem  <1
upper respiratory
   tract problem
 <1
asthma <1   <1

Urogenital

genitourinary
   disorder

 <1
sexual dysfunction  <1   <1

Metabolic

abnormal lab value  <1
weight change <1   <1

Musculoskeletal

extremity pain  <1
back pain <1   <1

Skin and Appendages

rash  <1

Hematologic

bleeding <1  <1  2  <1

Special Senses

visual problem  5  <1

a Because patients are counted at each dose level tested, the Any Dose column cannot be determined by adding across the doses.

In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m2 with dosing every 8 hours for a total of 9 doses, no torsade de pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m2 daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m2 daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTc ≥ 525 msec were seen in 2 patients at the 210 mg/m2 daily dose level. Serious adverse events including death, torsade de pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.

Potential Adverse Effects
Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol during investigational use and foreign marketing experience.



REPORTS OF SUSPECTED SOTALOL SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Sotalol side effects / adverse reactions in 51 year old male

Reported by a physician from United States on 2012-06-07

Patient: 51 year old male

Reactions: Completed Suicide

Adverse event resulted in: death

Suspect drug(s):
Sotalol

Diazepam

Verapamil HCL
    Administration route: Oral



See index of all Sotalol side effect reports >>

Drug label data at the top of this Page last updated: 2013-08-15

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