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INNOPRAN-XL (PROPRANOLOL HYDROCHLORIDE): ADVERSE REACTIONS / SIDE EFFECTS

The following adverse events were observed and have been reported with use of formulations of sustained- or immediate-release Propranolol (InnoPran-XL) capsules.

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, lassitude, mental depression manifested by insomnia, weakness, fatigue; reversible mental depression progressing to catatonia; hallucinations; visual disturbances; 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, abdominal cramping, epigastric distress, constipation, diarrhea, mesenteric arterial thrombosis, ischemic colitis.

Allergic

Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Respiratory

Bronchospasm.

Hematologic

Agranulocytosis, thrombocytopenic purpura, nonthrombocytopenic purpura.

Autoimmune

In extremely rare instances, systemic lupus erythematosus has been reported.

Skin

Stevens-Johnson syndrome; exfoliative dermatitis; toxic epidermal necrolysis; erythema multiforme; urticaria.

Musculoskeletal

Myopathy, myotonia.

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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