ADVERSE REACTIONS
Adverse events occurring at a rate of ≥3%, excluding those reported more commonly in placebo encountered in the InnoPran XL placebo-controlled hypertension trials and are plausibly related to treatment are shown in Table 1.
Table 1.Treatment Emergent Adverse Events Reported In ≥ 3% of Subjects | Body System |
Placebo
(N=88) | InnoPran XL |
80 mg
(N=89) | 120 mg
(N=85) |
| Fatigue | 3 (3.0%) | 4 (5.0%) | 6 (7.0%) |
| Dizziness (except vertigo) | 2 (2.0%) | 6 (7.0%) | 3 (4.0%) |
| Constipation | 0 | 3 (3.0%) | 1 (1.0%) |
The following adverse events were observed and have been reported with use of formulations of sustained- or immediate-release propranolol.
Cardiovascular:
Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.
Central Nervous System:
Light-headedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; reversible mental depression progressing to catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate-release formulations, fatigue, lethargy, and vivid dreams appear dose related.
Gastrointestinal:
Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.
Allergic:
Pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.
Respiratory:
Bronchospasm.
Hematologic:
Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
Autoimmune:
In extremely rare instances, systemic lupus erythematosus has been reported.
Miscellaneous:
Alopecia, LE-like reactions, psoriasiform rashes, dry eyes, male impotence, and Peyronie’s disease have been reported rarely. Oculomucocutaneous reactions involving the skin, serous membranes, and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO INNOPRAN XL
Below is a sample of reports where side effects / adverse reactions may be related to Innopran XL. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Innopran XL side effects / adverse reactions in 89 year old female
Reported by a individual with unspecified qualification from United States on 2007-10-31
Patient: 89 year old female weighing 59.0 kg (129.7 pounds)
Reactions: OFF Label USE, Mental Impairment, Overdose, Medication Error, Activities of Daily Living Impaired, Bronchospasm, Catatonia, Feeling Abnormal, Decreased Appetite
Suspect drug(s):
Innopran XL
Dosage: 80 mg;qd; 80 mg;qid;
Indication: Paralysis
Start date: 2005-01-01
End date: 2007-08-10
Innopran XL
Dosage: 80 mg;qd; 80 mg;qid;
Indication: Paralysis
Start date: 2007-08-10
End date: 2007-09-08
Innopran XL
Dosage: 80 mg;qd; 80 mg;qid;
Indication: Paralysis
Start date: 2007-09-08
Other drugs received by patient: Diovan/01319601/; Ativan
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