Cotolone Side Effects
Generic name: prednisolone
Medically reviewed by Drugs.com. Last updated on May 23, 2022.
Note: This document contains side effect information about prednisolone. Some of the dosage forms listed on this page may not apply to the brand name Cotolone.
For the Consumer
Applies to prednisolone: oral solution, oral syrup, oral tablets
Side effects include:
For Healthcare Professionals
Applies to prednisolone: compounding powder, injectable solution, injectable suspension, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet disintegrating
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]
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]
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]
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]
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]
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]
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]
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: Leucocytosis[Ref]
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]
Frequency not reported: Elevation in serum liver enzyme levels, hepatomegaly[Ref]
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]
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: Kaposi's sarcoma[Ref]
Frequently asked questions
- Prednisone vs Prednisolone - What's the difference?
- Is prednisolone best taken in the morning and why?
More about Cotolone (prednisolone)
Related treatment guides
1. "Product Information. Prelone (prednisolone)." Muro Pharmaceuticals Inc (2006):
2. "Product Information. Pediapred (prednisoLONE)." Apothecon Inc (2022):
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. "Product Information. Orapred ODT (prednisolone)." Concordia Pharmaceuticals (2016):
6. "Product Information. PrednisoLONE (prednisolone)." Watson Pharmaceuticals (2016):
Some side effects may not be reported. You may report them to the FDA.