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Innopran XL (Propranolol Hydrochloride) - Side Effects and Adverse Reactions

 
 



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.



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

Suspect drug(s):
Nitrofurantoin

Dipyrone TAB

Vitamin (Formulation Unknown) (Vitamin)

Furosemide
    Dosage: 40 mg/twice per day

Ceftriaxone
    Dosage: intramuscular
    Indication: Pyelonephritis

Innopran XL
    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

Suspect drug(s):
Innopran XL

Other drugs received by patient: Zoloft; Fortical



See index of all Innopran XL side effect reports >>

Drug label data at the top of this Page last updated: 2013-12-01

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