Deltasone Side Effects

Generic Name: prednisone

Note: This page contains information about the side effects of prednisone. Some of the dosage forms included on this document may not apply to the brand name Deltasone.

Not all side effects for Deltasone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to prednisone: oral solution, oral syrup, oral tablet, oral tablet delayed release

In addition to its needed effects, some unwanted effects may be caused by prednisone (the active ingredient contained in Deltasone). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking prednisone:

More common
  • Aggression
  • agitation
  • anxiety
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irritability
  • mental depression
  • mood changes
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • troubled breathing at rest
  • weight gain
Incidence not known
  • Abdominal or stomach cramping or burning (severe)
  • abdominal or stomach pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of skin
  • decrease in height
  • decreased vision
  • diarrhea
  • dry mouth
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sleeplessness
  • sweating
  • trouble healing
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

Some of the side effects that can occur with prednisone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • thinning of the scalp hair

For Healthcare Professionals

Applies to prednisone: compounding powder, oral delayed release tablet, oral solution, oral tablet

General

Adverse 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.

Adverse effects of prednisone (the active ingredient contained in Deltasone) 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 have included hypernatremia (rare), 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 other direct vascular effects.

Up to 12% of patients may develop systolic hypertension. Hypertension has been associated with long-term therapy with prednisone 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 activity may be suppressed for up to 12 months following long-term therapy with prednisone (the active ingredient contained in Deltasone) Cushingoid appearance commonly has 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 prednisone is taken. Diabetes mellitus requiring therapy with diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression may 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 adverse 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 generally have been used to manage GI complaints without significant drug interactions.

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

Immunologic

Patients treated with an average of 10 mg per day over several months 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.

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

Musculoskeletal

Corticosteroid myopathy has presented as weakness and wasting of the proximal limb and girdle muscles and generally has been 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 of 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 prednisone (the active ingredient contained in Deltasone) 7.5 mg per day and tamoxifen.

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

Ocular

In renal transplant patients maintained on prednisone (the active ingredient contained in Deltasone) 10 mg per day, 33% developed posterior subcapsular cataracts. Mean time to cataract development was 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

Other side effects have included a glucocorticoid withdrawal syndrome which has been associated with abrupt discontinuation of prednisone (the active ingredient contained in Deltasone) therapy and may not be associated with adrenal suppression.

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.

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 easy bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.

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