Pentam 300 Side Effects
Generic Name: pentamidine
Note: This page contains side effects data for the generic drug pentamidine. It is possible that some of the dosage forms included below may not apply to the brand name Pentam 300.
It is possible that some side effects of Pentam 300 may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to pentamidine: inhalation powder for solution
Other dosage forms:
On rare occasions, pneumocystis infections have occurred in parts of the body outside the lungs in patients receiving pentamidine (the active ingredient contained in Pentam 300) inhalation therapy. You should discuss this possible problem with your doctor.
As well as its needed effects, pentamidine may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking pentamidine, check with your doctor immediately:More common
- Burning pain, dryness, or sensation of lump in throat
- chest pain or congestion
- difficulty in breathing
- difficulty in swallowing
- skin rash
- Nausea and vomiting
- pain in upper abdomen, possibly radiating to the back
- pain in side of chest (severe)
- shortness of breath (sudden and severe)
- cold sweats
- cool, pale skin
- decreased urination
- increased hunger
- loss of appetite
- nausea and vomiting
- stomach pain
- unusual tiredness
For Healthcare Professionals
Applies to pentamidine: inhalation powder for reconstitution, injectable powder for injection
Parenteral administration is commonly associated with nephrotoxicity (increased creatinine, impaired renal function, azotemia, and renal failure). Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis, and cardiac arrhythmias have occurred with IM and IV pentamidine (the active ingredient contained in Pentam 300)
Inhaled pentamidine has been most frequently associated with cough and bronchospasm.
Side effects related to pentamidine are generally more frequent in patients with AIDS.[Ref]
Nephrotoxicity is frequently mild to moderate and does not require drug discontinuation. However, acute renal failure may develop and necessitates drug withdrawal. Renal function often returns to baseline after discontinuation. Hyperkalemia, which may be severe, has been reported. In several cases, potassium binding therapy or hemodialysis was required. Frequent monitoring of potassium is recommended during pentamidine (the active ingredient contained in Pentam 300) therapy.[Ref]
Renal side effects associated with parenteral pentamidine have included azotemia (8.5%), elevated serum creatinine (23.6%), elevated blood urea nitrogen (6.6%), and impaired renal function (28.8%). Nephritis, renal failure, and renal pain have been reported in less than 1% of patients receiving inhaled pentamidine. Renal dysfunction, and increased blood urea nitrogen (BUN) and serum creatinine have also been reported during postmarketing experience with inhaled pentamidine.[Ref]
Pentamidine has been reported to cause torsades de pointes and ventricular arrhythmias. These arrhythmias are reversible but may require antiarrhythmic therapy for several days following drug discontinuation. In many cases, the development of torsades de pointes did not occur until after about 10 days of therapy. In one prospective study of 14 patients, torsades de pointes developed in 3 of the subjects.
Sudden and severe hypotension has occurred after single IM or IV doses of pentamidine (the active ingredient contained in Pentam 300) Rapid IV administration increases the likelihood of severe hypotension.
Persistent hypotension accompanied by a fixed heart rate has been reported in an AIDS patient after 2 weeks of pentamidine therapy and was attributed to acute autonomic failure. Autonomic insufficiency resulting from pentamidine therapy is rare but should be suspected when there is chronic hypotension occurring in a phase of a fixed heart rate, and should be treated aggressively. Discontinuation of pentamidine should be considered.[Ref]
Cardiovascular side effects have included hypotension in 1% to 5% of patients, and abnormal ST segment on EKG, arrhythmias, cerebrovascular accident, hypertension, palpitations, poor circulation, syncope, tachycardia, vasodilatation, vasculitis, ventricular tachycardia in less than 1% of patients. QT prolongation, torsade de pointes, cardiac arrest, and sudden death have also been reported.[Ref]
Prior administration of a nebulized beta-agonist may lessen the bronchospasm. Aerosolized pentamidine (the active ingredient contained in Pentam 300) is also associated with an increased risk of developing AIDS-related spontaneous pneumothorax.
Reactive airways dysfunction syndrome (RADS) has been reported in a nurse after exposure to aerosolized pentamidine. Her symptoms and requirement for asthma medication persisted for at least 2 years after exposure.[Ref]
Respiratory side effects most commonly associated with inhaled pentamidine have included cough (38%) and bronchospasm (15%). Chest pain, wheezing, asthma, bronchitis, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, nonspecific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, nonspecific sputum, and tachypnea have also been reported.[Ref]
Pancreatitis may be preceded by glucose abnormalities, renal insufficiency, and abdominal pain. Pancreatitis has been reported during both aerosolized and intravenous pentamidine (the active ingredient contained in Pentam 300) therapy. Fatalities have been reported.
In some cases of pentamidine-induced pancreatitis, the patient had been receiving aerosolized therapy prophylactically prior to developing pancreatitis during intravenous therapy for the treatment of PCP. Extensive necrosis of the pancreatic acinar and islet cells with a black or reddish-black appearance has been seen on autopsy.[Ref]
Gastrointestinal side effects have included anorexia, diarrhea, nausea, and bad taste in less than 5% of patients. Abdominal cramps and pain, constipation, dry mouth, dyspepsia, gastritis, gastric ulcer, gingivitis, hiatal hernia, hypersalivation, melena, oral ulcer/abscess, pancreatitis, splenomegaly, vomiting, and loss of taste have been reported in less than 1% of patients. Colitis, esophagitis, and hematochezia have been reported during postmarketing experience.[Ref]
Metabolic side effects have included hypoglycemia in up to 5.9% of patients, and hyperglycemia, hyperkalemia, hypocalcemia, and hypomagnesemia in less than 1% of patients. Diabetes, ketoacidosis, and syndrome of inappropriate antidiuretic hormone have been reported during postmarketing experience.[Ref]
Hypoglycemia has been associated with pancreatic islet cell necrosis and high plasma insulin concentrations.
Hyperglycemia and diabetes has been reported with or without preceding hypoglycemia. Hypoglycemia may require treatment with intravenous glucose and, in some instances, glucagon. Hyperglycemia may follow, and in some cases has necessitated insulin therapy. This condition may not be reversible. A review of 15 cases of diabetes mellitus resulting from pentamidine administration revealed a mean duration of 26 days of intravenous therapy and one year of aerosolized therapy prior to the development of diabetes. Four of these patients presented with ketoacidosis. The diabetes was transient in one-third of these cases.
Increased urine excretion of magnesium has been noted in some patients exhibiting hypomagnesemia.[Ref]
Hematologic side effects have included anemia (less than 5%), leukopenia (parenteral, 10.4%), and thrombocytopenia (parenteral, 2.6%). Defibrination, cytopenia, eosinophilia, neutropenia, pancytopenia, and prolonged clotting time have been reported in less than 1% of patients. Hemolytic anemia (following parenteral pentamidine (the active ingredient contained in Pentam 300) and megaloblastic anemia have been reported.[Ref]
Hepatic side effects have included elevation of liver function tests in 8.7% of patients, and hepatitis, hepatomegaly, and hepatic dysfunction in less than 1% of patients.[Ref]
Local side effects have included sterile abscess, necrosis, pain, and/or induration at the site of intramuscular injection in 11.1% of patients, phlebitis in less than 1% of patients. Intravenous administration has been associated with transient erythema, pain, pruritus, and rash at the IV site and along the vein. Ulceration, tissue necrosis, and/or sloughing has occurred after extravasation.[Ref]
In some cases of extravasation, surgical debridement and skin grafting was required. Long-term sequelae have also been reported.
Although infrequently described, there have been case reports of erythema, pain, and pruritus occurring at the intravenous injection site and extending along the vein. These effects have been typically reversible upon discontinuation of the infusion. The volume of dilution and duration of infusion did not appear to affect the reaction in the described cases. Premedication with antihistamines provided inconsistent results. Improvement was seen with hydroxyzine premedication but not with diphenhydramine.[Ref]
Dermatologic side effects have included rash in up to 3.3% of patients, and desquamation, dry and breaking hair, dry skin, erythema, dermatitis, pruritus, and urticaria in less than 1% of patients.[Ref]
Nervous system side effects have included headache in less than 5% of patients. Anxiety, confusion, depression, dizziness, drowsiness, emotional lability, hallucination, hypesthesia, insomnia, memory loss, nervousness, neuralgia, neuropathy, paranoia, paresthesia, peripheral neuropathy, facial numbness, seizure, tremors, unsteady gait, and vertigo have been reported in less than 1% of patients.[Ref]
Other side effects have included night sweats in less than 5% of patients, and body odor, chills, extrapulmonary pneumocystosis, facial edema, fever, leg edema, lethargy, low body temperature, and abnormal temperature in less than 1% of patients. Asthenia has also been reported.[Ref]
Infectious side effects have included bronchitis, herpes, herpes zoster, influenza, oral candidiasis, pharyngitis, sinusitis, and upper respiratory tract infections in less than 5% of patients. Bacterial pneumonia, central venous line-related sepsis, cryptococcal meningitis, cytomegalovirus (CMV) colitis, CMV retinitis, esophageal candidiasis, histoplasmosis, Kaposi's sarcoma, nonspecific Mycoplasma, oral herpes, nonspecific otitis, nonspecific pharyngitis, pharyngeal herpes, nonspecific serious infections, tonsillitis, tuberculosis, and viral encephalitis have been reported in less than 1% of patients.[Ref]
Musculoskeletal side effects have included arthralgia, gout, and myalgia in less than 1% of patients.[Ref]
Genitourinary side effects have included miscarriage, flank pain, and incontinence in less than 1% of patients. Hematuria has also been reported.[Ref]
Ocular side effects have included blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, and hemianopsia in less than 1% of patients.[Ref]
Hypersensitivity reactions have included anaphylaxis, allergic reactions (urticaria, itching, rash), and Stevens-Johnson syndrome in less than 1% of patients. Toxic epidermal necrolysis has been reported; at least one case was associated with aerosolized pentamidine (the active ingredient contained in Pentam 300) [Ref]
1. Leigh TR, Wiggins J, Gazzard BG, Collins JV "Effect of terbutaline on bronchoconstriction induced by nebulised pentamidine." Thorax 46 (1991): 122-3
2. Watarai A, Niiyama S, Amoh Y, Katsuoka K "Toxic epidermal necrolysis caused by aerosolized pentamidine." Am J Med 122 (2009): e1-2
3. Quieffin J, Hunter J, Schechter MT, et al "Aerosol pentamidine-induced bronchoconstriction." Chest 100 (1991): 624-7
4. "Product Information. NebuPent (pentamidine)." Fujisawa, Deerfield, IL.
5. Ong EL, Hanley SP, Mandal BK "Bronchoconstriction, nebulised pantamidine, and mast cells." Lancet 04/29/89 (1989): 956
6. Chan C, Montaner J, Lefebvre EA, Morey G, Dohn M, McIvor RA, Scott J, Marina R, Caldwell P "Atovaquone suspension compared with aerosolized pentamidine for prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected subjects intolerant of trimethoprim or sulfonamides." J Infec Dis 180 (1999): 369-76
7. "Product Information. Pentam 300 (pentamidine)." Fujisawa, Deerfield, IL.
8. Sensakovic JW, Suarez M, Perez G, et al "Pentamidine treatment of pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome." Arch Intern Med 145 (1985): 2247
9. Peltz S, Hashmi S "Pentamidine-induced severe hyperkalemia." Am J Med 87 (1989): 698-9
10. Miller RF, Delany S, Semple SJ "Acute renal failure after nebulised pentamidine." Lancet 06/03/89 (1989): 1271-2
11. Pattullo AL, Meynard M, Bow EJ "Hematuria associated with pentamidine therapy for pneumocystis carinii pneumonia." AIDS 6 (1992): 595-7
12. Lachaal M, Venuto RC "Nephrotoxicity and hyperkalemia in patients with AIDS treated with pentamidine." Am J Med 87 (1989): 260-3
13. Chapelon C, Raguin G, De Gennes C "Renal insufficiency with nebulised pentamidine." Lancet 10/28/89 (1989): 1045-6
14. O'Brien JG, Dong BJ, Coleman RL, Gee L, Balano KB "A 5-year retrospective review of adverse drug reactions and their risk factors in human immunodeficiency virus-infected patients wh were receiving intravenous pentamidine therapy for Pneumocysti carinii pneumonia." Clin Infect Dis 24 (1997): 854-9
15. Shuster M, Dunn M "Pentamidine and hematuria." Ann Intern Med 105 (1986): 146
16. Milligan KS, Phillips DL "Perioral Numbness Associated with Intravenous Pentamidine Administration (January)." Ann Pharmacother 41 (2007): 153-6
17. Siddiqui MA, Ford PA "Acute severe autonomic insufficiency during pentamidine therapy." South Med J 88 (1995): 1087-8
18. Girgis I, Gualberti J, Langan L, Malek S, Mustaciuolo V, Costantino T, McGinn TG "A prospective study of the effect of I.V. pentamidine therapy on ventricular arrhythmias and QTc prolongation in HIV-infected patients." Chest 112 (1997): 646-53
19. Wharton JM, Demopulos PA, Goldschlager N "Torsade de pointes during administration of pentamidine isethionate." Am J Med 83 (1987): 571-6
20. Zanetti LAF, Oliphant CM "Pentamidine-induced torsades de pointes." Ann Pharmacother 28 (1994): 282-3
21. Gonzalez A, Sager PT, Akil B, et al "Pentamidine-induced torsade de pointes." Am Heart J 122 (1991): 1489-92
22. Bronner U, Gustafsson LL, Doua F, Ericsson O, Miezan T, Rais M, Rombo L "Pharmacokinetics and adverse reactions after a single dose of pentamidine in patients with trypanosoma gambiense sleeping sickness." Br J Clin Pharmacol 39 (1995): 289-95
23. Eisenhauer MD, Eliasson AH, Taylor AJ, Coyne PE, Wortham DC "Incidence of cardiac arrhythmias during intravenous pentamidine therapy in hiv-infected patients." Chest 105 (1994): 389-95
24. Cardoso JS, MotaMiranda A, Conde C, Moura B, RochaGoncalves F, Lecour H "Inhalatory pentamidine therapy and the duration of the QT interval in HIV-infected patients." Int J Cardiol 59 (1997): 285-9
25. Owens RC Jr, Nolin TD "Antimicrobial-Associated QT Interval Prolongation: Pointes of Interest." Clin Infect Dis 43 (2006): 1603-1611
26. Stein KM, Fenton C, Lehany AM, et al "Incidence of QT interval prolongation during pentamidine therapy of pneumocystis carinii pneumonia." Am J Cardiol 68 (1991): 1091-4
27. Balslev U, Berild D, Nielsen TL "Cardiac arrest during treatment of pneumocystis carinii pneumonia with intravenous pentamidine isethionate." Scand J Infect Dis 24 (1992): 111-2
28. Quadrel MA, Atkin SH, Jaker MA "Delayed cardiotoxicity during treatment with intravenous pentamidine: two case reports and a review of the literature." Am Heart J 123 (1992): 1377-9
29. Katzman M, Meade W, Iglar K, et al "High incidence of bronchospasm with regular administration of aerosolised pentamidine." Chest 101 (1992): 79-81
30. Metersky ML, Colt HG, Olson LK, Shanks TG "AIDS-related spontaneous pneumothorax: risk factors and treatment." Chest 108 (1995): 946-51
31. Stanbury M, Gatti E, Sokolowski JW "Reactive airways dysfunction syndrome in a nurse exposed to pentamidine." J Occup Environ Med 38 (1996): 330-1
32. Wei CCY, Pack LL, Chan CK "Effects of long-term aerosol pentamidine for Pneumocystis carinii prophylaxis on pulmonary function." Chest 114 (1998): 742-7
33. Harrison KS, Laube BL "Bronchodilator pretreatment improves aerosol deposition uniformity in HIV-positive patients who cough while inhaling aerosolized pentamidine." Chest 106 (1994): 421-6
34. Chan CK, Hyland RH, Yu D-G, et al "Acute pulmonary effects of aerosolized pentamidine: a randomized controlled study." Chest 98 (1990): 907-10
35. Tocci G, Alba L, D'Amato C, Grisetti S, Sampaolesi A, Visco GL "Pancreatitis associated with aerosolized pentamidine." Int Conf AIDS 9 (1993): 505
36. Wood G, Wetzig N, Hogan P, Whitby M "Survival from pentamidine induced pancreatitis and diabetes mellitus." Aust N Z J Med 21 (1991): 341-2
37. Sauleda J, Gea JG, Aguar MC, Aran X, Pasto M, Broquetas JM "Probable pentamidine-induced acute pancreatitis." Ann Pharmacother 28 (1994): 52-3
38. Schwartz MS, Cappell MS "Pentamidine-associated pancreatitis." Dig Dis Sci 34 (1989): 1617-20
39. Klatt EC "Pathology of pentamidine-induced pancreatitis." Arch Pathol Lab Med 116 (1992): 162-4
40. Nasti G, Zanette G, Inchiostro S, Donadon V, Tirelli U "Diabetes mellitus following intraveaous pentamidine administration in a patient with HIV infection." Arch Intern Med 155 (1995): 645-6
41. Nielsen H "Hypomagnesaemia associated with pentamidine therapy." AIDS 8 (1994): 561-3
42. Gradon JD, Fricchione L, Sepkowitz D "Severe hypomagnesemia associated with pentamidine therapy." Rev Infect Dis 13 (1991): 511-2
43. Dube MP "Disorders of glucose metabolism in patients infected with human immunodeficiency virus." Clin Infect Dis 31 (2000): 1467-75
44. Coyle P, Carr AD, Depczynski BB, Chisholm DJ "Diabetes mellitus associated with pentamidine use in HIV-infected patients." Med J Aust 165 (1996): 587-8
45. Mani S "Pentamidine-induced renal magnesium wasting." AIDS 6 (1992): 594-5
46. Taguchi H, Takahashi T, Wada T, Nakamura T, Amoto AI "Pentamidine-induced hemolytic anemia in an AIDS patient." Ann Pharmacother 33 (1999): 503
47. Andersen R, Boedicker M, Ma M, Goldstein EJ "Adverse reactions associated with pentamidine isethionate in AIDS patients: recommendations for monitoring therapy." Drug Intell Clin Pharm 20 (1986): 862-8
48. Western KA, Perera DR, Schultz MG "Pentamidine isethionate in the treatment of pneumocystis carinii pneumonia." Ann Intern Med 73 (1970): 695-702
49. Pearson RD, Hewlett EL "Pentamidine for the treatment of pneumocystis carinii pneumonia and other protozoal diseases." Ann Intern Med 103 (1985): 782-6
50. Montgomery AB, Debs RJ, Luce JM, et al "Aerosolised pentamidine as sole therapy for pneumocystis carinii pneumonia in patients with AIDS." Lancet 08/29/87 (1987): 480-3
51. Conte JE, Hollander H, Golden JA "Inhaled or reduced-dose intravenous pentamidine for pneumocystis carinii pneumonia." Ann Intern Med 107 (1987): 495-8
52. Herrero Ambrosio A, Gonzalez del Valle L, Gonzalez Garcia J "Vein irritation from i.v. pentamidine." Am J Health Syst Pharm 53 (1996): 2881-2
53. Anderson JM "Suspected vein irritation from i.v. pentamidine isethionate." Am J Health Syst Pharm 53 (1996): 185
54. Bolognia JL "Cutaneous ulceration: an unusual complication of intravenous pentamidine therapy." Dermatology 183 (1991): 221-4
55. Leen CL, Mandal BK "Rash due to nebulised pentamidine." Lancet 11/26/88 (1988): 1250-1
56. Ambrosio AH, Delvalle LG, Garcia JG "Vein irritation from iv pentamidine." Am J Health Syst Pharm 53 (1996): 2881-2
57. Berger TG, Tappero JW, Leoung GS, Jacobson MA "Aerosolised pentamidine and cutaneous eruptions." Ann Intern Med 110 (1989): 1035-6
More about Pentam 300 (pentamidine)
- Other brands: Nebupent
Related treatment guides
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.