ADVERSE REACTIONS
The most frequently reported unsolicited adverse events (1 to 5%) in clinical trials, regardless of their relation to NebuPent therapy were as follows (n=931):
Body as a Whole:
Night sweats.
Gastrointestinal:
Diarrhea and nausea.
Hematologic:
Anemia.
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 abnormality.
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, and thrombocytopenia.
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.
Reproductive:
Miscarriage.
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 renal pain.
In a clinical trial where some adverse events were solicited by investigators, the incidences were as follows:
Cough (62.7%)
Decreased appetite (50.0%)
Dizziness or light-headedness (45.1%)
Fatigue (65.7%)
Fever (51.0%)
Non-specific serious infection (15.2%)
Shortness of breath (48.3%)
Wheezing (32.4%)
From post-marketing clinical experience with NebuPent 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.
|