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Nebupent (Pentamidine Isethionate) - Side Effects and Adverse Reactions

 
 



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.



REPORTS OF SUSPECTED NEBUPENT SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Nebupent side effects / adverse reactions in 63 year old male

Reported by a pharmacist from United States on 2011-10-25

Patient: 63 year old male weighing 95.6 kg (210.3 pounds)

Reactions: Dyspnoea, Wheezing, Erythema, Oxygen Saturation Decreased

Suspect drug(s):
Nebupent



Possible Nebupent side effects / adverse reactions in 67 year old male

Reported by a pharmacist from United States on 2011-10-25

Patient: 67 year old male weighing 78.3 kg (172.3 pounds)

Reactions: Dyspnoea, Skin Discolouration, Wheezing, Oxygen Saturation Decreased

Suspect drug(s):
Nebupent



Possible Nebupent side effects / adverse reactions in 50 year old male

Reported by a pharmacist from United States on 2011-10-25

Patient: 50 year old male weighing 87.5 kg (192.5 pounds)

Reactions: Dyspnoea, Skin Discolouration, Wheezing, Oxygen Saturation Decreased

Suspect drug(s):
Nebupent



See index of all Nebupent side effect reports >>

Drug label data at the top of this Page last updated: 2010-12-07

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