Proglycem Side Effects

Generic Name: diazoxide

Please note - some side effects for Proglycem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Proglycem - for the Consumer

Proglycem Suspension

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 Proglycem Suspension:

Diarrhea; excessive hair growth; headache; loss of appetite; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Proglycem Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; excessive hunger or thirst; fast or irregular heartbeat; frequent urination; fruity breath; sudden weight gain; sweating; swelling of the feet or ankles.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Proglycem Side Effects - for the Professional

Proglycem

Frequent and Serious

Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. It usually responds to diuretic therapy.

Infrequent but Serious

Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Conventional therapy with insulin and restoration of fluid and electrolyte balance is usually effective if instituted promptly. Prolonged surveillance is essential in view of the long half-life of Proglycem®.

Other frequent adverse reactions

Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of the drug.

Hyperglycemia or glycosuria may require reduction in dosage in order to avoid progression to ketoacidosis or hyperosmolar coma.

Gastrointestinal intolerance may include anorexia, nausea, vomiting, abdominal pain, ileus, diarrhea, transient loss of taste.

Tachycardia, palpitations, increased levels of serum uric acid are common.

Thrombocytopenia with or without purpura may require discontinuation of the drug. Neutropenia is transient, is not associated with increased susceptibility to infection, and ordinarily does not require discontinuation of the drug. Skin rash, headache, weakness, and malaise may also occur.

Other adverse reactions which have been observed are

Cardiovascular: hypotension occurs occasionally, which may be augmented by thiazide diuretics given concurrently. A few cases of transient hypertension, for which no explanation is apparent, have been noted. Chest pain has been reported rarely.

Hematologic: eosinophilia; decreased hemoglobin / hematocrit; excessive bleeding, decreased IgG.

Hepato-renal: increased AST, alkaline phosphatase; azotemia, decreased creatinine clearance, reversible nephrotic syndrome, decreased urinary output, hematuria, albuminuria. Neurologic: anxiety, dizziness, insomnia, polyneuritis, paresthesia, pruritus, extrapyramidal signs. Ophthalmologic: transient cataracts, subconjunctival hemorrhage, ring scotoma, blurred vision, diplopia, lacrimation. Skeletal, integumentary; monilial dermatitis, herpes, advance in bone age; loss of scalp hair. Systemic: fever, lymphadenopathy. Other; gout acute pancreatitis/pancreatic necrosis, galactorrhea, enlargement of lump in breast.

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Side Effects by Body System - for Healthcare Professionals

General

The most common reactions reported following diazoxide administration include hypotension (7%), nausea and vomiting (4%), dizziness and weakness (2%).

Cardiovascular

Cardiovascular effects including sodium and water retention following repeated injections, hypotension, shock, myocardial ischemia, myocardial and cerebral infarction, angina, atrial and ventricular arrhythmias, marked electrocardiographic changes, optic nerve infarction, supraventricular tachycardia and palpitation, bradycardia, and chest discomfort have been reported.

Angina with myocardial and cerebral infarction have been associated with the use of a 300 mg intravenous dose of diazoxide.

One case of optic nerve infarction was reported following a single 300 mg bolus dose of diazoxide, as a result of a sudden reduction in diastolic pressure.

Results from one prospective trial conducted in patients with severe hypertension and coronary artery disease showed a 50% incidence of ischemic changes in the electrocardiogram following single 300 mg bolus injections of diazoxide.

Nervous system

Nervous system affects reported following diazoxide administration include cerebral ischemia, convulsions, paralysis, confusion, numbness of the hands, orthostatic hypotension, sweating, flushing, generalized or localized sensations of warmth, headache, dizziness, lightheadedness, sleepiness, lethargy, somnolence, drowsiness, euphoria, tinnitus, momentary loss of hearing, weakness and anxiety.

Gastrointestinal

Gastrointestinal side effects have been rarely reported and include acute pancreatitis, nausea, vomiting, abdominal discomfort, anorexia, alteration in taste, parotid swelling, salivation, dry mouth, lacrimation, ileus, constipation and diarrhea.

Metabolic

Metabolic effects including hyperglycemia have been reported in diabetic and nondiabetic patients, especially after repeated injections. Transient retention of nitrogenous wastes has also been reported.

Respiratory

Respiratory effects including dyspnea, cough and choking sensation have been reported.

Hypersensitivity

Hypersensitivity reactions characterized by rash, leukopenia, fever and papilledema induced by plasma volume expansion secondary to the administration of diazoxide have been reported.

Other

Other effects including warmth or pain along the injected vein, cellulitis and/or phlebitis at the injection site of extravasation, back pain, increased nocturia, malaise, blurred vision, hirsutism, and decreased libido have been reported.

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