MEDROL® TABLETS Adverse Reactions

(methylprednisolone TABLETS)

ADVERSE REACTIONS

Fluid and Electrolyte Disturbances

•
Sodium retention
•
Congestive heart failure in susceptible patients
•
Hypertension
•
Fluid retention
•
Potassium loss
•
Hypokalemic alkalosis

Musculoskeletal

•
Muscle weakness
•
Loss of muscle mass
•
Steroid myopathy
•
Osteoporosis
•
Tendon rupture, particularly of the Achilles tendon
•
Vertebral compression fractures
•
Aseptic necrosis of femoral and humeral heads
•
Pathologic fracture of long bones

Gastrointestinal

•
Peptic ulcer with possible perforation and hemorrhage
•
Pancreatitis
•
Abdominal distention
•
Ulcerative esophagitis

Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic

•
Impaired wound healing
•
Petechiae and ecchymoses
•
May suppress reactions to skin tests
•
Thin fragile skin
•
Facial erythema
•
Increased sweating

Neurological

•
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
•
Convulsions
•
Vertigo
•
Headache

Endocrine

•
Development of Cushingoid state
•
Suppression of growth in children
•
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
•
Menstrual irregularities
•
Decreased carbohydrate tolerance
•
Manifestations of latent diabetes mellitus
•
Increased requirements of insulin or oral hypoglycemic agents in diabetics

Ophthalmic

•
Posterior subcapsular cataracts
•
Increased intraocular pressure
•
Glaucoma
•
Exophthalmos

Metabolic

•
Negative nitrogen balance due to protein catabolism

The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

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Health Professional Information

Adverse Reactions

ADVERSE REACTIONS

Fluid and Electrolyte Disturbances

•
Sodium retention
•
Congestive heart failure in susceptible patients
•
Hypertension
•
Fluid retention
•
Potassium loss
•
Hypokalemic alkalosis

Musculoskeletal

•
Muscle weakness
•
Loss of muscle mass
•
Steroid myopathy
•
Osteoporosis
•
Tendon rupture, particularly of the Achilles tendon
•
Vertebral compression fractures
•
Aseptic necrosis of femoral and humeral heads
•
Pathologic fracture of long bones

Gastrointestinal

•
Peptic ulcer with possible perforation and hemorrhage
•
Pancreatitis
•
Abdominal distention
•
Ulcerative esophagitis

Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic

•
Impaired wound healing
•
Petechiae and ecchymoses
•
May suppress reactions to skin tests
•
Thin fragile skin
•
Facial erythema
•
Increased sweating

Neurological

•
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
•
Convulsions
•
Vertigo
•
Headache

Endocrine

•
Development of Cushingoid state
•
Suppression of growth in children
•
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
•
Menstrual irregularities
•
Decreased carbohydrate tolerance
•
Manifestations of latent diabetes mellitus
•
Increased requirements of insulin or oral hypoglycemic agents in diabetics

Ophthalmic

•
Posterior subcapsular cataracts
•
Increased intraocular pressure
•
Glaucoma
•
Exophthalmos

Metabolic

•
Negative nitrogen balance due to protein catabolism

The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

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