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Inderal XL (Propranolol Hydrochloride) - Side Effects and 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 ³3%, excluding those reported more commonly in placebo, encountered in the INDERAL 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
        INDERAL 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 INDERAL 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.

Drug label data at the top of this Page last updated: 2013-11-01

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