Applies to prednisolone: oral solution, oral syrup, oral tablet, oral tablet disintegrating.

Serious side effects of Prednisolone

Along with its needed effects, prednisolone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking prednisolone:

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 cramping and/or burning (severe)
• abdominal 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
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/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

Other side effects of Prednisolone

Some side effects of prednisolone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 prednisolone: compounding powder, injectable solution, injectable suspension, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet disintegrating.

General

The most commonly occurring side effects have included fluid retention, alteration in glucose tolerance, increased blood pressure, behavioral and mood changes, increased appetite, and weight gain; the incidence often correlates with dosage, timing of administration, and duration of treatment.^[Ref]

Metabolic

Calciphylaxis has been reported rarely with corticosteroid use, most commonly in patients with ESRD; although some patients have had minimal or no renal impairment with normal calcium, phosphate, and parathyroid hormone levels.^[Ref]

Common (1% to 10%): Alteration in glucose tolerance, increased appetite, weight gain

Rare (0.01% to 0.1%): Calciphylaxis

Frequency not reported: Potassium losses, hypokalemia alkalosis, sodium retention, negative nitrogen balance due to protein catabolism, manifestation of latent diabetes mellitus, increases in total cholesterol, low density lipoproteins, and triglycerides, obesity, dyslipidemia, calciphylaxis^[Ref]

Cardiovascular

Common (1% to 10%): Fluid retention, blood pressure elevations

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, edema^[Ref]

Endocrine

Frequency not reported: Hirsutism, development of cushingoid state, hyperthyroidism, hypothyroidism, moon face, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery, or illness)^[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis, esophageal candidiasis, dyspepsia, abdominal pain, diarrhea, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), vomiting^[Ref]

Immunologic

Frequency not reported: Opportunistic infections (bacterial, viral, fungal and parasitic infections), recurrence of dormant tuberculosis, suppressed response to skin tests^[Ref]

Musculoskeletal

Frequency not reported: 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 (particularly of the Achilles tendon), vertebral compression fractures, growth suppression in pediatric patients (infancy, childhood and adolescence), proximal myopathy, vertebral and long bone fractures, avascular osteonecrosis, tendinopathies, myalgia^[Ref]

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.^[Ref]

Ocular

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, nuclear cataracts (particularly in children), corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease^[Ref]

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.^[Ref]

Psychiatric

A wide range of psychiatric reactions have been commonly reported in both adults and children. The frequency of severe reactions has been estimated at around 5% to 6%. Psychological effects have been reported on withdrawal of corticosteroids, the frequency of this is unknown.^[Ref]

Common (1% to 10%): Behavioral changes, mood changes, irritability, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, aggravation of schizophrenia, anxiety, sleep disorders, amnesia

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, euphoria, psychological dependence^[Ref]

Hematologic

Frequency not reported: Leucocytosis^[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous fat atrophy, dry scalp, edema, facial erythema, hyper or hypo pigmentation, impaired wound healing, increased sweating, petechiae, ecchymosis, rash, sterile abscess, striae, suppressed reactions to skin tests, thinning of skin, thinning scalp hair, urticaria, hirsutism, bruising, telangiectasia, rash, perineal irritation^[Ref]

Genitourinary

Frequency not reported: Amenorrhea, postmenopausal bleeding or menstrual irregularities, increased or decreased motility and number of spermatozoa^[Ref]

Hepatic

Frequency not reported: Elevation in serum liver enzyme levels, hepatomegaly^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis, angioedema^[Ref]

Nervous system

Frequency not reported: Arachnoiditis, convulsions, headache, increased intracranial hypertension with papilledema (pseudotumour cerebri) usually following discontinuation of therapy, meningitis, neuritis, neuropathy, paraparesis/paraplegia, paraesthesia, sensory disturbances, aggravation of epilepsy, clinical signs of evolving stroke, EEG abnormalities, increased motor activity, ischemic neuropathy, severe tiredness, weakness^[Ref]

Other

A steroid withdrawal syndrome unrelated to adrenocortical insufficiency has been reported following discontinuation. The syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules, weight loss, and/or hypotension. These effects may be due to the sudden change in glucocorticosteroid concentrations rather than to low corticosteroid levels.^[Ref]

Frequency not reported: Malaise, vertigo, fatigue, impaired healing, steroid withdrawal syndrome^[Ref]

Respiratory

Frequency not reported: Pulmonary edema, hiccups^[Ref]

Oncologic

Kaposi's sarcoma has been reported among patients receiving corticosteroid therapy; discontinuation may result in clinical remission.^[Ref]

Frequency not reported: Kaposi's sarcoma^[Ref]