ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring at a rate of ≥3%, excluding those reported more commonly in placebo, encountered in the INNOPRAN XL placebo-controlled hypertension trials and plausibly related to treatment are shown in Table 1.
Table 1. Treatment Emergent Adverse Reactions Reported In ≥3% of Subjects
| |
|
INNOPRAN XL
|
| |
Placebo
|
80 mg
|
120 mg
|
| Body System
|
(N=88)
|
(N=89)
|
(N=85)
|
| Fatigue |
3 (3%) |
4 (5%) |
6 (7%) |
| Dizziness (except vertigo) |
2 (2%) |
6 (7%) |
3 (4%) |
| Constipation |
0 |
3 (3%) |
1 (1%) |
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-marketing use of INNOPRAN XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions were observed and have been reported with use of formulations of sustained- or immediate-release propranolol.
Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.
Autoimmune: Systemic lupus erythematosus (SLE).
Cardiovascular: exacerbation of peripheral arterial disease, arterial insufficiency, usually of the Raynaud type.
Central Nervous System: Light-headedness, mental depression, insomnia, lassitude, weakness, fatigue visual disturbances, hallucinations, vivid dreams, short-term memory loss, emotional lability, slightly clouded sensorium, paresthesia of hands
Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, mesenteric arterial thrombosis, ischemic colitis.
Genitourinary: Male impotence; Peyronie’s disease.
Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
Musculoskeletal:
Myopathy, myotonia
Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes.
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