Flo-Pred Side Effects

Generic Name: prednisolone,prednisolone acetate

Please note - some side effects for Flo-Pred 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 Flo-Pred - for the Consumer

Flo-Pred 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 Flo-Pred Suspension:

Acne; dizziness; facial flushing; headache; increased appetite; increased sweating; mild swelling; nausea; nervousness; trouble sleeping; upset stomach; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; burning, numbness, or tingling; calf or leg pain, swelling, redness, or tenderness; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, depression); muscle pain, cramps, weakness, or wasting; numbness of an arm or leg; persistent trouble sleeping; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or stomach or back pain; severe or persistent swelling of the hands, arms, feet, or legs; shortness of breath; symptoms of infection (eg, fever, chills, persistent sore throat); tendon or bone pain; thinning of skin; 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.

Flo-Pred Side Effects - for the Professional

Flo-Pred

Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria

Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, 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: Fluid retention, potassium loss, hypertension, hypokalemic alkalosis, sodium retention

Gastrointestinal: Abdominal distention, elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis

General: Increased appetite and weight gain

Metabolic: Negative nitrogen balance due to protein catabolism

Musculoskeletal: Aseptic necrosis of femoral and humeral heads, charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures

Neurological: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually following discontinuation of treatment, insomnia, meningitis, mood swings, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, and posterior subcapsular cataracts

Reproductive: Alteration in motility and number of spermatozoa

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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