Nexpro-20/Nexpro-40/Nexpro IV Adverse Reactions

Nexpro-20/Nexpro-40: The following adverse drug reactions have been identified or suspected in the clinical trials program for esomeprazole and post-marketing. None was found to be dose-related. The reactions are classified according to frequency (common>1/100, <1/10; uncommon>1/1000, <1/100; rare>1/10000, <1/1000; very rare <1/10000).
Blood and Lymphatic System Disorders: Rare: Leukopenia, thrombocytopenia; Very rare: Agranulocytosis, pancytopenia.
Immune System Disorders: Rare: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock.
Metabolism and Nutrition Disorders: Uncommon: Peripheral oedema; Rare: Hyponatraemia.
Psychiatric Disorders: Uncommon: Insomnia; Rare: Agitation, confusion, depression; Very rare: Aggression, hallucinations.
Nervous System Disorders: Common: Headache; Uncommon: Dizziness, paraesthesia, somnolence; Rare: Taste disturbance.
Eye Disorders: Rare: Blurred vision.
Ear and Labyrinth Disorders: Uncommon: Vertigo.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Bronchospasm.
Gastrointestinal Disorders: Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting; Uncommon: Dry mouth; Rare: Stomatitis, gastrointestinal candidiasis.
Hepatobiliary Disorders: Uncommon: Increased liver enzymes; Rare: Hepatitis with or without jaundice; Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease.
Skin and Subcutaneous Tissue Disorders: Uncommon: Dermatitis, pruritus, rash, urticaria; Rare: Alopecia, photosensitivity; Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).
Musculoskeletal, Connective Tissue and Bone Disorders: Rare: Arthralgia, myalgia; Very rare: Muscular weakness.
Renal and Urinary Disorders: Very rare: Interstitial nephritis.
Reproductive System and Breast Disorders: Very rare: Gynaecomastia.
General Disorders and Administration Site Conditions: Rare: Malaise, increased sweating.
Nexpro IV: Common Side effects: Constipation; diarrhea; dry mouth; gas; headache; nausea; pain, swelling, or redness at the injection site; stomach pain.
Severe Side effects: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; fast heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; unusual bruising or bleeding; unusual tiredness. Seek medical attention right away if any of these severe side effects occur.