Orapred Side Effects

Generic Name: prednisolone,prednisolone acetate

Please note - some side effects for Orapred 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 Orapred - for the Consumer

Orapred ODT

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 Orapred ODT:

Dizziness; facial flushing; headache; increased appetite; increased sweating; lightheadedness; nausea; nervousness; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; depression; fever, chills, or sore throat; lesions in the mouth or throat; mental or mood changes; muscle pain or weakness; seizures; severe nausea or vomiting; severe stomach or back pain; sudden severe dizziness or headache; swelling of the ankles, feet, or hands; tendon or bone pain; thinning of skin; trouble sleeping; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

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.

Orapred Solution

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 Orapred Solution:

Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

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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Orapred Side Effects - for the Professional

Orapred

(listed alphabetically under each subsection):

Cardiovascular: Hypertrophic cardiomyopathy in premature infants.

Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema.

Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children.

Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention.

Gastrointestinal: Abdominal distention; elevation in serum liver enzyme levels (usually reversible upon discontinuation); pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads; loss of muscle mass; muscle weakness; osteoporosis; pathologic fracture of long bones; steroid myopathy; tendon rupture; vertebral compression fractures.

Neurological: Convulsions; headache; increased intracranial pressure with papilledema (pseudotumor cerebri), usually following discontinuation of treatment; psychic disorders; vertigo.

Ophthalmic: Exophthalmos; glaucoma; increased intraocular pressure; posterior subcapsular cataracts.

Other: Increased appetite; malaise; nausea; weight gain.

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Side Effects by Body System - for Healthcare Professionals

General

Patients treated with an average of 10 mg per day over several months have developed 50% fewer infections compared to those treated with an average of 20 mg per day. Significantly fewer episodes of aseptic necrosis and a trend toward fewer complications in general have been reported with lower dosages.

Side effects have occurred less frequently when minimum dosages were employed. Dosages greater than 10 mg per day have been associated with an increased incidence of adverse events.

The side effects of prednisolone may be subdivided into those associated with short-term therapy (to three weeks) and those of long-term therapy (> three weeks).

Short-term effects have included sodium retention-related weight gain and fluid accumulation, hyperglycemia and glucose intolerance, hypokalemia, gastrointestinal upset and ulceration, reversible depression of the hypothalamic-pituitary-adrenal (HPA) axis, and mood changes ranging from mild euphoria and insomnia to nervousness, restlessness, mania, catatonia, depression, delusions, hallucinations, and violent behavior.

Long-term effects have included HPA suppression, Cushingoid appearance, hirsutism or virilism, impotence, and menstrual irregularities, peptic ulcer disease, cataracts and increased intraocular pressure/glaucoma, myopathy, osteoporosis, and vertebral compression fractures.

Metabolic

Metabolic side effects of prednisolone have included hypernatremia, hypokalemia, fluid retention, negative nitrogen balance and increased blood urea nitrogen concentration. Glucocorticoids have been reported to decrease the secretion of thyrotropin (TSH).

Cardiovascular

Cardiovascular side effects have included hypertension and congestive heart failure due to long-term fluid retention and direct vascular effects.

Up to 12% of patients may develop systolic hypertension. Hypertension has been associated with long-term therapy with corticosteroids and is thought to be due to fluid retention. One author has associated these changes in blood pressure with advancing age.

Endocrine

Endocrine side effects have included glucose intolerance and hyperglycemia. Diabetes-like symptoms may develop in some individuals. Hypothalamic-pituitary-adrenal suppression may be prolonged to 12 months following long-term therapy with prednisolone. Cushingoid appearance has commonly occurred with chronic therapy. In addition, hirsutism or virilism, impotence, and menstrual irregularities may occur with chronic therapy.

Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Patients on alternate day therapy may exhibit significantly higher serum glucose on the day prednisolone is taken. Diabetes mellitus requiring therapy with diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression can persist up to twelve months after long-term corticosteroid therapy. Adrenal suppression may be reduced by giving corticosteroids once a day or once every other day. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during times of stress (illness, surgery, trauma) may be required.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis as well as gastrointestinal perforation and hemorrhage have also been reported.

Gastrointestinal effects most commonly have included nausea, vomiting, dyspepsia, and anorexia. Peptic ulcer disease has been associated with long-term corticosteroid therapy, but is relatively uncommon. Routine prophylactic therapy is not warranted in all individuals. Aluminum/magnesium containing antacids may be used to manage GI complaints without significant drug interactions.

Immunologic

Immunologic side effects have included impairment of cell-mediated immunity which increases patient susceptibility to bacterial, viral, fungal and parasitic infections. In addition, the immune response to skin tests may be suppressed.

Musculoskeletal

Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression fractures, and aseptic necrosis of bone. Aseptic necrosis has been reported to most often affect the femoral head.

Corticosteroid myopathy presents as weakness and wasting of the proximal limb and girdle muscles and is generally reversible following cessation of therapy.

Corticosteroids inhibit intestinal calcium absorption and increase urinary calcium excretion leading to bone resorption and bone loss. Bone loss of 3% over one year has been demonstrated with prednisolone 10 mg per day. Postmenopausal females are particularly at risk for loss of bone density. Sixteen percent of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures. One author reported measurable bone loss over two years in women on concomitant therapy with prednisolone 7.5 mg per day and tamoxifen.

Ocular

In renal transplant patients maintained on prednisolone 10 mg per day, 33% developed posterior subcapsular cataracts. Mean time to cataract development is 26 months. Increased intraocular pressure has occurred in 5% of patients.

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.

Other

Pseudorheumatism, or glucocorticoid-withdrawal syndrome, has occurred upon withdrawal of corticosteroids but was not related to adrenal insufficiency. Patients experienced anorexia, nausea, vomiting, lethargy, headache, fever, arthralgias, myalgias and postural hypotension. Symptoms resolved when corticosteroid therapy was reinstated.

Other side effects have included a glucocorticoid withdrawal syndrome, which resulted from abrupt discontinuation of prednisolone therapy and may not have been associated with adrenal suppression.

Psychiatric

Psychiatric side effects have included psychoses, behavioral changes, and pseudotumor cerebri.

Hematologic

Hematologic side effects have included thrombocytopenia, lymphopenia, and platelet alterations resulting in thrombolic events.

Dermatologic

Dermatologic side effects have included bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.

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