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SOLU-CORTEF (Hydrocortisone sodium succinate for injection USP) Adverse Reactions

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Adverse Reactions

The following Adverse Reactions have been reported with the systemic use of SOLU-CORTEF and/or other corticosteroid preparations.

Table 1. Adverse Reactions

System Organ Class

Adverse Drug Reactions

Infections and infestations

Opportunistic infection;

Infection;

Infection susceptibility increased

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Kaposi’s sarcoma (has been reported to occur in patients receiving corticosteroid therapy)

Blood and lymphatic system disorders

Leukocytosis

Immune system disorders

Drug hypersensitivity;

Anaphylactic reaction;

Anaphylactoid reaction

Endocrine disorders

Cushingoid;

Hypopituitarism;

Hirsutism;

Hypertrichosis;

Abnormal fat deposits;

Weight increased;

Moon face;

Glycosuria;

Steroid withdrawal syndrome

Metabolism and nutrition disorders

Metabolic acidosis;

Sodium retention;

Fluid retention;

Alkalosis hypokalaemic;

Dyslipidaemia;

Glucose tolerance impaired;

Increased insulin requirement (or oral hypoglycemic agents in diabetics);

Lipomatosis;

Increased appetite (which may result in weight increased)

Nitrogen balance negative (due to protein catabolism)

Psychiatric disorders

Affective disorder (including depression, euphoric mood, affect lability, drug dependence, suicidal ideation);

Psychotic disorder (including mania, delusion, hallucination and schizophrenia);

Mental disorder;

Personality change;

Confusional state;

Anxiety;

Mood swings;

Abnormal behavior;

Insomnia;

Irritability

Nervous system disorders

Intracranial pressure increased with papilloedema (benign intracranial hypertension) usually following discontinuation of treatment;

Seizure;

Amnesia;

Cognitive disorder;

Dizziness;

Headache;

Neuritis;

Neuropathy peripheral;

Paraesthesia;

Arachnoiditis;

Meningitis;

Paraparesis/paraplegia;

Sensory disturbance has occurred after intrathecal administration;

Epidural lipomatosis


Eye disorders

Cataract;

Exophthalmos;

Glaucoma;

Rare instances of blindness associated with periocular injections;

Central serous chorioretinopathy

Ear and labyrinth disorders

Vertigo

Cardiac disorders

Cardiac failure congestive (in susceptible patients);

Bradycardia;

Cardiac arrest;

Arrhythmia;

Cardiomegaly;

Circulatory collapse;

Fat embolism;

Hypertrophic cardiomyopathy in premature infants;

Myocardial rupture following recent myocardial

infarction (see WARNINGS AND PRECAUTIONS);

Pulmonary oedema;

Syncope;

Tachycardia;

Embolism;

Thrombophlebitis;

Vasculitis

Vascular disorders

Hypertension;

Hypotension;

Thrombosis

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism;

Hiccups

Gastrointestinal disorders

Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer hemorrhage);

Gastric hemorrhage;

Pancreatitis;

Oesophagitis ulcerative;

Intestinal perforation (of the small and large intestine, particularly in patients with inflammatory bowel disease);

Abdominal distension;

Abdominal pain;

Diarrhoea;

Dyspepsia;

Bowel/bladder dysfunction (after intrathecal administration);

Increased appetite (which may result in weight increased);

Nausea;

Elevation in serum liver enzyme levels (usually reversible upon discontinuation)

Skin and subcutaneous tissue disorders

Angioedema;

Petechiae;

Ecchymosis;

Cutaneous and subcutaneous atrophy;

Skin atrophy;

Acne;

Dermatitis allergic;

Burning sensation or tingling (especially in the perineal area, after intravenous injection);

Dry skin / Skin exfoliation;

Erythema;

Skin hyperpigmentation;

Skin hypopigmentation;

Hyperhidrosis;

Rash;

Abscess sterile;

Skin striae;

Alopecia;

Pruritus;

Urticaria

Musculoskeletal and connective tissue disorders

Myopathy;

Muscular weakness;

Osteonecrosis of femoral and humeral heads;

Osteoporosis;

Pathological fracture of long bones, postinjection flare (following intra-articular use);

Growth retardation;

Neuropathic arthropathy;

Muscle atrophy;

Myalgia;

Arthralgia

Reproductive system and breast disorders

Menstruation irregular;

Spermatozoa progressive motility abnormal / sperm concentration abnormal

General disorders and administration site conditions

Impaired healing;

Oedema peripheral;

Fatigue;

Malaise;

Injection site reaction

Investigations

Intraocular pressure increased;

Carbohydrate tolerance decreased;

Blood potassium decreased;

Urine calcium increased;

Alanine aminotransferase increased;

Aspartate aminotransferase increased;

Blood alkaline phosphatase increased;

Hepatomegaly;

Blood urea increased;

Suppression of reactions to skin tests

Injury, poisoning and procedural complications

Spinal compression fracture;

Tendon rupture

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