Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis, renal impairment and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate.
Life threatening reactions: Blood and lymphatic system disorders: Leucopenia (less than 1,000 cells per cubic millimetre), thrombocytopenia (less than 20,000 cells per cubic millimetre).
Immune system disorders: Herxheimer reaction.
Metabolism and nutrition disorders: Severe hypoglycaemia, hypocalcaemia.
Psychiatric disorders: Toxic delirium.
Nervous system disorders: Syncope.
Cardiac disorders: Cardiac arrhythmias and cardiac arrest (including QT interval prolongation and torsade de pointes), ventricular tachycardia.
Vascular disorders: severe hypotension.
Gastrointestinal disorders: acute pancreatitis.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (single possible case).
Renal and urinary disorders: Acute renal failure.
The previously mentioned adverse effects can be severe, sometimes fatal, and require immediate corrective measures and withdrawal of treatment.
Other reactions: Other adverse reactions reported are listed in this section per MedDRA system organ class.
Blood and lymphatic system disorders: Anaemia, thrombocytopenia, leucopenia.
Metabolism and nutrition disorders: Hypocalcaemia, hypoglycaemia, hyperglycaemia, hyperkalaemia, hyponatraemia, diabetes mellitus.
Psychiatric disorders: Hallucinations.
Nervous system disorders: Taste disturbances, dizziness, syncope.
Cardiac disorders: Tachycardia, bradycardia.
Vascular disorders: Hypotension, facial flushing, venous thrombosis.
Respiratory, thoracic and mediastinal disorders: Breathlessness.
Local reactions ranging in severity from cough, breathlessness, wheezing, bronchospasms (with inhaled use), particularly in patients with a history of smoking or asthma, which can usually be controlled by prior use of bronchodilator.
Gastrointestinal disorders: Nausea, vomiting.
Hepatobiliary disorders: Abnormal liver function (hepatic dysfunction).
Skin and subcutaneous tissue disorders: Abscess and/or necrosis, rash, itching, alopecia, erythema multiforme.
Renal and urinary disorders: Azotaemia, albuminuria, glycosuria, increased creatinine levels.
General disorders and administration site conditions: Local reactions at the injection site including abscess, pain, thrombophlebitis.
Investigations: Depressed serum folate.
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.