(listed alphabetically, under each subsection)
The following adverse reactions have been reported with
prednisone or other corticosteroids:
anaphylactoid or hypersensitivity reactions, anaphylaxis,
bradycardia, cardiac arrest, cardiac arrhythmias, cardiac
enlargement, circulatory collapse, congestive heart failure, ECG changes caused
by potassium deficiency, edema, fat embolism, hypertension or aggravation of
hypertension, hypertrophic cardiomyopathy in premature infants, myocardial
rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal),
necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis,
acne, acneiform eruptions, allergic dermatitis, alopecia,
angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin,
ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired
wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General
Precautions ), lupus erythematosus-like lesions, perineal irritation,
purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to
skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair,
Adrenal insufficiency-greatest potential caused by high
potency glucocorticoids with long duration of action (associated symptoms
include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea,
severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other
menstrual irregularities, decreased carbohydrate and glucose tolerance,
development of cushingoid state, diabetes mellitus (new onset or manifestations
of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS:
Endocrine), hypothyroidism, increased requirements for insulin or oral
hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen
balance caused by protein catabolism, secondary adrenocortical and pituitary
unresponsiveness (particularly in times of stress, as in trauma, surgery or
illness) (see WARNINGS: Endocrine), suppression of growth in pediatric
Fluid And Electrolyte Disturbances
congestive heart failure in susceptible patients, fluid
retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension
or shock-like reaction, potassium loss, sodium retention with resulting edema.
abdominal distention, abdominal pain,anorexia which may
result in weight loss, constipation, diarrhea, elevation in serum liver enzyme
levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly,
increased appetite and weight gain, nausea, oropharyngeal candidiasis,
pancreatitis, peptic ulcer with possible perforation and hemorrhage,
perforation of the small and large intestine (particularly in patients with
inflammatory bowel disease), ulcerative esophagitis, vomiting.
anemia, neutropenia (including febrile neutropenia).
negative nitrogen balance due to protein catabolism.
arthralgias, aseptic necrosis of femoral and humeral
heads, increase risk of fracture, loss of muscle mass, muscle weakness,
myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal),
pathologic fracture of long bones, steroid myopathy, tendon rupture
(particularly of the Achilles tendon), vertebral compression fractures.
amnesia, anxiety, benign intracranial hypertension,
convulsions, delirium, dementia (characterized by deficits in memory retention,
attention, concentration, mental speed and efficiency, and occupational performance),
depression, dizziness, EEG abnormalities, emotional instability and
irritability, euphoria, hallucinations, headache, impaired cognition, incidence
of severe psychiatric symptoms, increased intracranial pressure with
papilledema (pseudotumor cerebri) usually following discontinuation of treatment,
increased motor activity, insomnia, ischemic neuropathy, long-term memory loss,
mania, mood swings, neuritis, neuropathy, paresthesia, personality changes,
psychiatric disorders including steroid psychoses or aggravation of
pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory
loss, vertigo, withdrawn behavior.
blurred vision, cataracts (including posterior
subcapsular cataracts), central serous chorioretinopathy, establishment of
secondary bacterial, fungal and viral infections, exophthalmos, glaucoma,
increased intraocular pressure (see PRECAUTIONS: Ophthalmic),
optic nerve damage, papilledema.
abnormal fat deposits, aggravation/masking of infections,
decreased resistance to infection (see WARNINGS: Infection),
hiccups, immunosuppresion, increased or decreased motility and number of spermatozoa,
malaise, insomnia, moon face, pyrexia.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at
1-800-272-5525 or FDA at 1- 800-FDA-1088 or http://www.fda.gov/ for voluntary
reporting of advers e reactions .