"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Nebupent Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
NebuPent (pentamidine isethionate) is used to prevent and treat serious infections such as Pneumocystis pneumonia (PCP), often seen in people with acquired immunodeficiency syndrome (AIDS). It is an antibiotic. Common side effects include cough, upset stomach, loss of appetite, nausea, vomiting, diarrhea, dizziness, headache, burning feeling in the throat, or unusual taste/dryness in the mouth.
The recommended adult dosage of NebuPent for the prevention of Pneumocystis pneumonia is 300 mg once every four weeks administered via the Respirgard II nebulizer. NebuPent may interact with azathioprine, carbamazepine, antibiotics, anti-inflammatory drugs, cisplatin, didanosine, zidovudine, birth control pills, ganciclovir, blood pressure medications, medication for diabetes, valproic acid, medication for psychiatric disorders, or metoclopramide. Tell your doctor all medications and supplements you use. During pregnancy, NebuPent should be used only when prescribed. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.
Our NebuPent (pentamidine isethionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Nebupent in Detail - Patient Information: Side Effects
Side effects with pentamidine are not common. Serious side effects include:
- an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
- blurred vision;
- chest pain or irregular heart beat;
- difficulty breathing;
- dizziness, confusion, fainting spells or excessive tiredness;
- drastic appetite changes;
- pain or irritation at the injection site;
- mouth ulcers or irritations;
- severe stomach pain;
- bleeding or bruising;
- severe headache;
- increased thirst; or
Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience
- taste changes;
- diarrhea; or
- nausea or vomiting.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Nebupent (Pentamidine Isethionate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Nebupent Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor or respiratory therapist immediately if any of these unlikely but serious side effects occur: chest tightness, breathing problems.
Though very unlikely, inhaled pentamidine might be absorbed into your body. Tell your doctor immediately if any of these rare but serious side effects occur: abdominal pain, easy bruising/bleeding, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations), unusual decrease in the amount of urine, signs of anemia (such as severe tiredness, bluish skin/nails), signs of low blood pressure (such as severe dizziness, pale skin, fainting), signs of low blood sugar (such as sudden sweating, shaking, fast heartbeat, hunger), signs of high blood sugar (such as unusual increase in thirst or urination), signs of infection (such as fever, chills, persistent sore throat).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Nebupent (Pentamidine Isethionate)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Nebupent FDA Prescribing Information: Side Effects
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.
Nervous System: Headache.
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):
Gastrointestinal: Abdominal cramps, abdominal pain, constipation, dry mouth, dyspepsia, gastritis, gastric ulcer, gingivitis, hiatal hernia, hypersalivation, oral ulcer/abscess, splenomegaly, and vomiting.
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.
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.
In a clinical trial where some adverse events were solicited by investigators, the incidences were as follows:
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.
Read the entire FDA prescribing information for Nebupent (Pentamidine Isethionate)
Additional Nebupent Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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