InnoPran XL Side Effects

Generic Name: propranolol

Please note - some side effects for InnoPran XL may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of InnoPran XL - for the Consumer

InnoPran XL Sustained-Release Bead Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using InnoPran XL Sustained-Release Bead Capsules:

Constipation; diarrhea; dizziness; drowsiness; fatigue; lightheadedness; nausea; stomach upset or cramping; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; fever with aching and sore throat; hallucinations; memory loss; mental or mood changes; numbness or tingling of the hands; persistent or severe vision changes; red, swollen, blistered, or peeling skin; severe dizziness; shortness of breath or wheezing; sudden, unusual weight gain; swelling of the hands, ankles, or feet; unusual bruising; unusually slow heartbeat; very cold or blue fingers or toes.

InnoPran XL Side Effects - for the Professional

InnoPran XL

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.

 The following adverse events were observed and have been reported with use of formulations of sustained- or immediate-release propranolol.

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, 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.

Gastrointestinal:

Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.

Allergic:

Pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.

Respiratory:

Bronchospasm.

Hematologic:

Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Autoimmune:

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

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.

Side Effects by Body System

Cardiovascular

Use of a nonselective beta-blocker like propranolol may at least blunt cardiac output in some patients, especially those with preexisting left ventricular systolic dysfunction and during exertion. Data have shown that cardiac conditioning can delay or attenuate this side effect of propranolol.

Abrupt cessation of propranolol therapy may result in hypertension, myocardial infarction, and angina pectoris in some patients.

Paradoxical hypertension may occur in patients with pheochromocytoma, unless alpha-adrenergic blockade is already instituted.

At least two cases of electrical alternans associated with propranolol are reported from pediatric cases. In one case, electrical alternans was clearly not rate-related (since it occurred during propranolol therapy at a slower rate than the patient's "native" ventricular tachycardia) and was associated with echocardiographically-demonstrated mechanical alternans.

Cardiovascular side effects are the most common, and include hypotension, bradycardia, exacerbation of Raynaud's phenomenon, atrioventricular block, and congestive heart failure (CHF). Rare reports of weight gain in patients without apparent CHF have been associated with the use of propranolol. The mechanism of weight gain is unclear, but may be due to propranolol-induced water retention.

Nervous system

Nervous system side effects, such as fatigue, dizziness, impaired sleep, and dreams occur in approximately 2% to 5% of patients, and are more common with higher doses of propranolol.

Rare cases of paresthesias and myasthenia gravis have been associated with propranolol.

Renal

Renal insufficiency related to lowering of systemic blood pressure occurs in less than 1% of patients.

There are reports of patients who experienced reversible renal insufficiency with no decline in systemic blood pressure, but these patients had preexisting renal disease. This may be important in patients with preexisting renal insufficiency. New or worsened renal dysfunction has been reported in patients with underlying renal disease and no decline in systemic blood pressure.

Respiratory

Respiratory side effects include potential worsening of reactive airways diseases. Some large studies have shown that many patients, regardless of a history of lung disease, complain of dyspnea during propranolol monotherapy.

Limited data have shown a mean fall in maximal midexpiratory flow rate (MMFR) during propranolol therapy relative to placebo in nine of ten patients whose lung function was assessed. Interestingly, the fall was not related to smoking or to atopic status, suggestive of resting beta-adrenergic bronchodilator activity in nonasthmatic subjects.

Non-selective beta-blockers, such as propranolol, are used with caution in patients with asthma and chronic obstructive pulmonary disease due to inhibition of bronchodilation.

Endocrine

Beta-blockers, such as propranolol, are used with caution in patients with diabetes due to masking of the catecholamine response to hypoglycemia. Propranolol may also mask the signs of hyperthyroidism by the same mechanism.

Propranolol has been associated with significant increases in serum triglycerides, fasting blood glucose, and LDL and VLDL cholesterol, and significant decreases in HDL cholesterol.

Endocrinologic problems include hyperglycemia and hypertriglyceridemia. This may be important in some diabetic patients where masking symptoms of hypoglycemia, such as sweating and tachycardia may be unsafe. Propranolol, like other nonspecific beta-blockers, may adversely affect serum lipids.

Gastrointestinal

Gastrointestinal side effects, such as diarrhea, nausea, constipation, and vomiting are usually transient. Rarely, propranolol has been associated with elevated liver function tests and mesenteric ischemia.

Psychiatric

Psychiatric depression is associated with beta-blockers, particularly the more lipophilic, nonselective beta-blockers, like propranolol. Well described cases of major depressive episodes after initiation of propranolol therapy, which were dose-dependent and remittent upon drug discontinuation, have been reported.

One study of 34 hypertensive patients who were taking propranolol found the incidence of depressive symptoms in this population to be 50% to 74% (depending on the criteria used). Propranolol-induced depression may be more likely in patients with a personal or family history of depression. Of the 34 patients, 12 had a history of depression and 8 had a history of substance abuse, alcoholism, or a family history of psychiatric disorders. Since none of the 12 patients with a history of depression were clinically depressed at the start of propranolol therapy and were comparable by age, diagnosis, and propranolol dosage to the other 22 patients, a comparison was made. Patients with a personal or family history of depression had significantly higher scores on depression scales than those without such histories.

A 72-year-old retired college professor with no history of affective disorders developed progressive sadness, tearfulness, hopelessness, decreased energy, social withdrawal, anhedonia, insomnia, and decreased memory and concentration within two weeks after beginning propranolol monotherapy for hypertension. The signs and symptoms of depression resolved upon substitution with a thiazide diuretic. Interestingly, the patient later was treated for recurrent depression while not receiving propranolol.

Rare cases of psychoses associated with propranolol have been reported.

Hypersensitivity

Hypersensitivity is rare. Rare cases of anaphylaxis and contact dermatitis have been reported.

Hematologic

Hematologic side effects are rare. Propranolol may cause platelet dysfunction. Rare cases of purpura with and without normal platelet counts and cases of agranulocytosis have been reported.

Dermatologic

Dermatologic reactions are rare, and include cases of psoriatic flares. Other cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been associated with use of propranolol. Alopecia and SLE-like reactions have also been reported.

Immunologic

Limited data show that propranolol can enhance the immune system. The clinical significance of this is unknown.

Propranolol can enhance the immune system by causing an increase in the number of circulating T cells, increased interleukin-2 (IL-2) secretion, increased expression of IL-2 receptors, and increased lymphocyte production in response to the T cell mitogen Con A. Interestingly, NK (natural killer) cell activity may be decreased during propranolol therapy, although the number of circulating NK cells may remain unchanged. These results are consistent with previous data showing decreased immunologic function during periods of elevated sympathetic activity, such as congestive heart failure, uremia, or life-threatening events.

Genitourinary

Genitourinary side effects have included male impotence and Peyronie's disease.

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