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adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION : Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Nephrotoxic events (increased creatinine, impaired renal function, azotemia, and renal failure) are common with the parenteral administration of pentamidine isethionate. The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated. The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424): Cardiovascular: Hypotension 5.0% Gastrointestinal: Anorexia/Nausea 5.9% Hematologic: Anemia Leukopenia Thrombocytopenia 1.2% 10.4% 2.6% Hepatic: Elevated liver function tests 8.7% Metabolic: Hypoglycemia 5.9% Neurologic: Confusion/hallucinations 1.7% Skin: Sterile abscess and/or necrosis, pain, or induration at the site of IM injection Rash 11.1% 3.3% Special Senses: Bad taste 1.7% Urogenital: Azotemia Elevated serum creatinine Elevated blood urea nitrogen Impaired renal function 8.5% 23.6% 6.6% 28.8% Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events): Body as a whole: Allergic reaction (i.e. urticaria, itching, rash), anaphylaxis, arthralgia, chills, extrapulmonary pneumocystosis, headache, night sweats, and Stevens-Johnson syndrome. Cardiovascular: Abnormal ST segment of electrocardiogram, cardiac arrhythmias, cerebrovascular accident, hypertension, palpitations, phlebitis, syncope, tachycardia, vasodilatation, vasculitis and ventricular tachycardia. Gastrointestinal: Abdominal pain, diarrhea, dry mouth, dyspepsia, hematochezia, hypersalivation, melena, pancreatitis, splenomegaly, and vomiting. Hematological: Defibrination, eosinophilia, neutropenia, pancytopenia, and prolonged clotting time. Hepatic: Hepatic dysfunction, hepatitis and hepatomegaly Metabolic: Hyperglycemia, hyperkalemia, hypocalcemia, and hypomagnesemia. Neurological: Anxiety, confusion, depression, dizziness, drowsiness, emotional lability, hypesthesia, insomnia, memory loss, neuropathy, nervousness, neuralgia, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo. Respiratory system: Asthma, bronchitis, bronchospasm, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, non-specific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, and tachypnea. Skin: Desquamation, dry and breaking hair, dry skin, erythema, dermatitis, pruritus, rash, and urticaria. Special senses: Blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, loss of hearing, loss of taste, and loss of smell. Urogenital: Flank pain, hematuria, incontinence, nephritis, renal dysfunction and renal failure. From post-marketing clinical experience with pentamidine isethionate, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see WARNINGS ), and torsades de pointes.
adverse reactions table
<table><tbody><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Body as a whole:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Allergic reaction (i.e. urticaria, itching, rash), anaphylaxis, arthralgia, chills, extrapulmonary pneumocystosis, headache, night sweats, and Stevens-Johnson syndrome.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Cardiovascular:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Abnormal ST segment of electrocardiogram, cardiac arrhythmias, cerebrovascular accident, hypertension, palpitations, phlebitis, syncope, tachycardia, vasodilatation, vasculitis and ventricular tachycardia.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Gastrointestinal:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Abdominal pain, diarrhea, dry mouth, dyspepsia, hematochezia, hypersalivation, melena, pancreatitis, splenomegaly, and vomiting.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Hematological:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Defibrination, eosinophilia, neutropenia, pancytopenia, and prolonged clotting time.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Hepatic:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Hepatic dysfunction, hepatitis and hepatomegaly</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Metabolic:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Hyperglycemia, hyperkalemia, hypocalcemia, and hypomagnesemia.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Neurological:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Anxiety, confusion, depression, dizziness, drowsiness, emotional lability, hypesthesia, insomnia, memory loss, neuropathy, nervousness, neuralgia, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Respiratory system:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Asthma, bronchitis, bronchospasm, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, non-specific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, and tachypnea.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Skin:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Desquamation, dry and breaking hair, dry skin, erythema, dermatitis, pruritus, rash, and urticaria.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Special senses:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, loss of hearing, loss of taste, and loss of smell.</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Urogenital:</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" valign="top"><paragraph>Flank pain, hematuria, incontinence, nephritis, renal dysfunction and renal failure.</paragraph></td></tr></tbody></table>