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Pentam (Pentamidine Isethionate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.



REPORTS OF SUSPECTED PENTAM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Pentam. The information is not vetted and should not be considered as verified clinical evidence.

Possible Pentam side effects / adverse reactions in 17 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-18

Patient: 17 month old female

Reactions: Cystitis Haemorrhagic

Suspect drug(s):
Pentam

Other drugs received by patient: Zosyn; Megestrol Acetate; Oxybutynin; Mercaptopurine; Ivig (Immunoglobulin); Tobramycin; Bactrim; Morphine; Nystatin; Voriconazole; Zyrtec; Cyproheptadine HCL; Famotidine



Possible Pentam side effects / adverse reactions in 6 month old male

Reported by a pharmacist from United States on 2011-12-23

Patient: 6 month old male weighing 6.0 kg (13.2 pounds)

Reactions: NO Adverse Event, Accidental Overdose

Adverse event resulted in: hospitalization

Suspect drug(s):
Pentam

Other drugs received by patient: Antibiotics; Cellcept; Mycamine (Micafungin Sodium); Intravenous Fluid (Glucose); Ganciclovir



See index of all Pentam side effect reports >>

Drug label data at the top of this Page last updated: 2012-03-07

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