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 ||
| InnoPran XL |
| 80 mg|
| 120 mg|
|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.
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.
Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.
Pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.
Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
In extremely rare instances, systemic lupus erythematosus has been reported.
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.
REPORTS OF SUSPECTED INNOPRAN XL SIDE EFFECTS / ADVERSE REACTIONS
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 considered as verified clinical evidence.
Possible Innopran XL side effects / adverse reactions in 34 year old female
Reported by a individual with unspecified qualification from Brazil on 2011-10-28
Patient: 34 year old female weighing 55.9 kg (122.9 pounds)
Reactions: Parvovirus Infection, Agitation, Oligohydramnios, Bronchopneumonia, Lung Infection, Tricuspid Valve Incompetence, Caesarean Section, Oral Candidiasis, Immunosuppression, Cardiac Failure Congestive, Bronchopulmonary Aspergillosis, Metabolic Acidosis, Cardiac Murmur, Cytomegalovirus Test Positive, Maternal Exposure During Pregnancy, General Physical Health Deterioration, Respiratory Distress, Convulsion, Depressed Level of Consciousness, Septic Shock, Aortic Valve Incompetence, Pleural Fibrosis, Necrotising Bronchiolitis, Pallor, Multi-Organ Failure, Foetal Growth Restriction, Small FOR Dates Baby, Pulmonary Congestion, Bone Marrow Failure, Renal Failure Acute, Tracheobronchitis, Cardiogenic Shock, Tachycardia Foetal, Agranulocytosis, Cardiac Arrest, Blood Pressure Decreased, Leukocytosis, Leukopenia, Mitral Valve Stenosis, Shock
Adverse event resulted in: death, hospitalization
Vitamin (Formulation Unknown) (Vitamin)
Dosage: 40 mg/twice per day
Dosage: 40 mg/twice per day
Possible Innopran XL side effects / adverse reactions in 27 year old male
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: 27 year old male
Reactions: Lupus-Like Syndrome
Other drugs received by patient: Zoloft; Fortical