The most frequently reported unsolicited adverse events (1 to 5%) in clinical
trials, regardless of their relation to NebuPent (pentamidine isethionate) therapy were as follows (n=931):
Body as a Whole: Night sweats.
Gastrointestinal: Diarrhea and nausea.
Infection: Bronchitis, non-specific herpes, herpes zoster, non-specific
influenza, oral Candida, pharyngitis, sinusitis, and upper respiratory tract.
Nervous System: Headache.
Respiratory System: Chest pain, cough, and wheezing.
Special Senses: Bad taste.
Adverse events 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, non-specific allergy, body odor,
facial edema, fever, leg edema, lethargy, low body temperature, and temperature
Cardiovascular: Cerebrovascular accident, hypotension, hypertension,
palpitations, poor circulation, syncope, tachycardia, vasodilatation and vasculitis.
Gastrointestinal: Abdominal cramps, abdominal pain, constipation, dry
mouth, dyspepsia, gastritis, gastric ulcer, gingivitis, hiatal hernia, hypersalivation,
oral ulcer/abscess, splenomegaly, and vomiting.
Hematological: Eosinophilia, neutropenia, non-specific cytopenia, pancytopenia,
Hepatic: Hepatitis, hepatomegaly, and hepatic dysfunction.
Infection: Bacterial pneumonia, central venous line related sepsis,
cryptococcal meningitis, cytomegalovirus (CMV) colitis, CMV retinitis, esophageal
Candida, histoplasmosis, Kaposi's sarcoma, non-specific mycoplasma, oral herpes,
non- specific otitis, non-specific pharyngitis, pharyngeal herpes, non-specific
serious infection, tonsillitis, tuberculosis, and viral encephalitis.
Metabolic: Hyperglycemia, hypoglycemia, and hypocalcemia.
Musculoskeletal: Arthralgia, gout, and myalgia.
Neurological: Anxiety, confusion, depression, drowsiness, emotional
lability, hallucination, hypesthesia, insomnia, memory loss, neuralgia, neuropathy,
non- specific neuropathy, nervousness, 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, non-specific sputum, and tachypnea.
Skin: Desquamation, dry and breaking hair, dry skin, erythema, non-specific
dermatitis, pruritus, rash, and urticaria.
Special senses: Blepharitis, blurred vision, conjunctivitis, contact
lens discomfort, eye pain or discomfort, hemianopsia, loss of taste, non-specific
odor, and smell.
Urogenital: Flank pain, incontinence, nephritis, renal failure, and
In a clinical trial where some adverse events were solicited by investigators,
the incidences were as follows:
Decreased appetite (50.0%)
Dizziness or light-headedness (45.1%)
Non-specific serious infection (15.2%)
Shortness of breath (48.3%)
From post-marketing clinical experience with NebuPent (pentamidine isethionate) the following spontaneous
adverse events have been reported: anaphylaxis, colitis, diabetes, dyspnea,
esophigitis, hematochezia, increased blood urea nitrogen (BUN) and serum creatinine
levels, melena, pancreatitis (see WARNINGS), syndrome of inappropriate
antidiuretic hormone (SIADH), and torsade de pointes.
While specific studies on drug interactions with NebuPent (pentamidine isethionate) have not been conducted,
the majority of patients in clinical trials received concomitant medications,
including zidovudine, with no reported interactions. Because the nephrotoxic
effects may be additive, the concomitant or sequential use of NebuPent (pentamidine isethionate) and other
nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet,
or vancomycin should be closely monitored and avoided, if possible.