Fungizone Side Effects

Generic Name: amphotericin b

Note: This page contains information about the side effects of amphotericin b. Some of the dosage forms included on this document may not apply to the brand name Fungizone.

Not all side effects for Fungizone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amphotericin b: injectable, powder for solution

In addition to its needed effects, some unwanted effects may be caused by amphotericin b (the active ingredient contained in Fungizone). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking amphotericin b:

More commonWith intravenous injection
  • Fever and chills
  • headache
  • increased or decreased urination
  • irregular heartbeat
  • muscle cramps or pain
  • nausea
  • pain at the place of injection
  • unusual tiredness or weakness
  • vomiting
Less common or rareWith intravenous injection
  • Blurred or double vision
  • convulsions (seizures)
  • numbness, tingling, pain, or weakness in hands or feet
  • shortness of breath, troubled breathing, wheezing, or tightness in chest
  • skin rash or itching
  • sore throat and fever
  • unusual bleeding or bruising
With spinal injection
  • Blurred vision or any change in vision
  • difficult urination
  • numbness, tingling, pain, or weakness

Some of the side effects that can occur with amphotericin b may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More commonWith intravenous injection
  • Diarrhea
  • headache
  • indigestion
  • loss of appetite
  • nausea or vomiting
  • stomach pain
Less commonWith spinal injection
  • Back, leg, or neck pain
  • dizziness or lightheadedness
  • headache
  • nausea or vomiting

For Healthcare Professionals

Applies to amphotericin b: compounding powder, compounding powder for reconstitution, intravenous powder for injection, oral suspension

General

General side effects have included reactions during infusions. These have included fevers, chills, and rigors in 50% of patients during intravenous administration. The intensity of these acute, infusion-related side effects usually decreased over time, were probably cytokine-mediated, and have been lessened by pretreatment with corticosteroids, nonsteroidal anti-inflammatory drugs, antihistamines, and meperidine.[Ref]

Hydrocortisone 25 mg intravenously, just before or during amphotericin infusions, is usually an effective countermeasure against these side effects. In some cases, premedication with diphenhydramine hydrochloride 25 mg orally or intravenously is additionally effective.[Ref]

Renal

Renal side effects have included decreased renal function, azotemia, hyposthenuria, renal tubular acidosis, and nephrocalcinosis. These symptoms usually improved with interruption of therapy. However, in those patients receiving larger amounts (over 5 g) of amphotericin B or receiving other nephrotoxic agents, some permanent impairment often occurred. Hypercalciuria, nephrotoxicity, elevations in BUN, and elevations in serum creatinine have been reported. Rare cases of renal tubular necrosis have also been reported.[Ref]

Renal toxicity has been a common side effect of amphotericin B therapy and may be lessened by saline hydration, and is reversible upon temporary discontinuation of therapy. A typical regimen is the administration of 500 mL of normal saline infused prior to the amphotericin B infusion, with an additional 500 mL of normal saline infused just subsequent to the completion of a dose. Although no controlled trials have compared rapid and continuous infusions of amphotericin B, data from one controlled trial (n=80) showed a noticeable reduction in nephrotoxicity in the continuous infusion group. An amphotericin infusion rate of less than 0.08 mg/kg/hour appears to be a safe threshold associated with reduced renal impairment.

The need for hemodialysis due to amphotericin B induced nephrotoxicity appears to be greater in certain patient populations such as bone marrow transplant patients and patients whose creatinine levels exceed 2.5 mg/dL.

The hypercalciuria associated with amphotericin-induced distal renal tubular acidosis has resulted in nephrocalcinosis in rare cases.[Ref]

Metabolic

Although data are limited, amiloride at a dosage of 5 mg 2 times a day may be beneficial in preventing amphotericin B induced hypokalemia and hypomagnesemia.

A 21-year-old man with beta-thalassemia experienced hypoparathyroidism after using intravenous amphotericin B for C albicans infection.[Ref]

Metabolic side effects have included changes in electrolytes. Hypokalemia and hypomagnesemia have often accompanied amphotericin-induced nephrotoxicity, with up to 90% of patients requiring parenteral potassium replacement. In addition, hypothermia has been reported following intravenous administration. Hypocalcemia and hyperkalemia have been reported. Amphotericin B caused hypomagnesemia, which triggered hypoparathyroidism and hypocalcemia. All three abnormalities resolved after the drug was withdrawn. At least one case of hypoparathyroidism has also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, emesis, diarrhea, dyspepsia, cramping, epigastric pain, and anorexia. These have been commonly associated with amphotericin infusions. Hemorrhagic gastroenteritis and melena have also been reported. Intraperitoneal amphotericin has caused severe peritoneal inflammation, which resulted in persistent abdominal discomfort and peritoneal leukocytosis.[Ref]

Hematologic

Hematologic side effects have included reversible normocytic normochromic anemia. Agranulocytosis, coagulation defects, thrombocytopenia (rarely), leukopenia, eosinophilia, and leukocytosis have also been reported.[Ref]

A decrease in hemoglobin concentration of up to 35% has been noted in many cases. Anemia may be more likely and more severe in patients with preexisting renal dysfunction since some patients with renal failure have suppression of erythrocyte production, low erythropoietin, and low hemoglobin levels.[Ref]

Nervous system

Nervous system side effects have been reported rarely. Headaches have commonly been associated with amphotericin B infusions. Convulsions, hearing loss, tinnitus, transient vertigo, peripheral neuropathy, and encephalopathy have also been reported. Seizures, paresthesias, nerve palsies, micturition difficulties, and chemical meningitis have been associated with intrathecal amphotericin therapy.[Ref]

Multiple episodes of seizures immediately following intravenous infusion of amphotericin B have been reported in a 46-year-old African-American man with AIDS. On rechallenge, the seizures recurred and the drugs therapy was changed.[Ref]

Hypersensitivity

A 68-year-old male with organic brain syndrome precipitated by several strokes and who had an excision of a meningeoma experienced acute generalized exanthematous pustulosis coincident with amphotericin B therapy. He had been given amphotericin B suspension three weeks previously for oral candidosis. Upon hospitalization, amphotericin B was stopped. He was treated with corticosteroids, and the skin lesions improved dramatically. After a few days of therapy, he was discharged with near complete resolution of his skin lesions.[Ref]

Hypersensitivity side effects have included bronchospasm, hypotension, and urticaria. Hypersensitivity pneumonitis and hypersensitivity myocarditis have been reported. At least one case of acute generalized exanthematous pustulosis has also been reported.[Ref]

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included hypotension, tachypnea, cardiac arrest, shock, cardiac failure, pulmonary edema, arrhythmia, including ventricular fibrillation, dyspnea, hypertension, and transient asystole. Thrombophlebitis has occurred in many patients because of the long duration of intravenous therapy usually required.[Ref]

Thrombophlebitis may be decreased by frequent intravenous site rotation and decreasing the concentration of amphotericin in the infusate.[Ref]

Musculoskeletal

Musculoskeletal side effects have included myalgias and arthralgias. These side effects have been commonly associated with amphotericin infusions.[Ref]

Respiratory

Respiratory side effects have been reported rarely. Rare cases of acute respiratory deterioration, including adult respiratory syndrome and bronchiolitis obliterans, have been associated with amphotericin therapy. Dyspnea and hypoxemia associated with amphotericin therapy have been reported, especially when amphotericin is given with leukocyte transfusions.[Ref]

Hepatic

Hepatic side effects have been reported rarely. These have included acute liver failure, hepatitis, and jaundice. Changes in liver function test results have included elevations of AST, ALT, GGT, bilirubin, and alkaline phosphatase.[Ref]

Ocular

A rare case of blindness associated with amphotericin B therapy has been reported in a woman with lupus erythematosus and cryptococcal meningitis. Because cryptococcal meningitis may cause decreased visual acuity and optic atrophy, implication of amphotericin is difficult.[Ref]

Ocular side effects have rarely included visual impairment and diplopia. At least one case of blindness has also been reported.[Ref]

Local

Local side effects have included pain at the injection site with or without phlebitis or thrombophlebitis.[Ref]

The administration of amphotericin B on alternate days may decrease phlebitis.[Ref]

Dermatologic

Dermatologic side effects have included pruritus and maculopapular rash.[Ref]

References

1. Lyman C, Walsh T "Systemically administered antifungal agents." Drugs 44 (1992): 9-35

2. Gales MA, Gales BJ "Rapid infusion of amphotericin B in destrose." Ann Pharmacother 29 (1995): 523-9

3. Kan V, Bennett J, Amantea M, et al. "Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B desoxycholate in healthy male volunteers." J Infect Dis 164 (1991): 418-21

4. Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK "Injectable paromomycin for Visceral leishmaniasis in India." N Engl J Med 356 (2007): 2571-81

5. Griswold MW, Briceland LL, Stein DS "Is amphotericin B test dosing needed?" Ann Pharmacother 32 (1998): 475-7

6. Thompson GR 3rd, Cadena J, Patterson TF "Overview of antifungal agents." Clin Chest Med 30 (2009): 203-15, v

7. Nicholl TA, Nimmo CR, Shepherd JD, Phillips P, Jewesson PJ "Amphotericin B infusion-related toxicity: comparison of two- and four-hour infusions." Ann Pharmacother 29 (1995): 1081-7

8. Cruz JM, Peacock JE, Loomer L, et al "Rapid intravenous infusion of amphotericin B: a pilot study." Am J Med 93 (1992): 123-30

9. Goodwin SD, Cleary JD, Walawander CA, Taylor JW, Grasela TH "Pretreatment regimens for adverse events related to infusion of amphotericin B." Clin Infect Dis 20 (1995): 755-61

10. Fisher MA, Talbot GH Maislin G, McKeon BP, Tynan KP, Strom BL "Risk factors for amphotericin B-associated nephrotoxicity." Am J Med 87 (1989): 547-52

11. Harbarth S, Pestotnik SL, Lloyd JF, Burke JP, Samore MH "The epidemiology of nephrotoxicity associated with conventional amphotericin B therapy." Am J Med 111 (2001): 528-34

12. Deray G "Amphotericin B nephrotoxicity." J Antimicrob Chemother 49 Suppl A (2002): 37-41

13. "Amphotericin." Med Lett Drugs Ther 30 (1988): 30-2

14. Shindo K, Mizuno T, Matsumoto Y, et al "Granulocytopenia and thrombocytopenia associated with combination therapy of amphotericin B and low-dose flucytosine in a patient with cryptococcal meningitis." DICP 23 (1989): 672-4

15. "Product Information. Fungizone (amphotericin B)." Bristol-Myers Squibb, Princeton, NJ.

16. Eriksson U, Seifert B, Schaffner A "Comparison of effects of amphotericin B deoxycholate infused over 4 or 24 hours: randomised controlled trial." BMJ 322 (2001): 579-82

17. Bullock W, Luke R, Nuttall C, Bhathena D "Can mannitol reduce amphotericin B nephrotoxicity?" Antimicrob Agents Chemother 10 (1976): 555-63

18. Clements J, Peacock J "Amphotericin B revisited: reassessment of toxicity." Am J Med 88 (1990): n22-7

19. Girmenia C, Gentile G, Micozzi A, Martino P "Nephrotoxicity of amphotericin B desoxycholate." Clin Infect Dis 33 (2001): 915-6

20. McCurdy D, Frederic M, Elkinton JR "Renal tubular acidosis due to amphotericin B." N Engl J Med 268 (1968): 124-31

21. Peleg AY, Woods ML "Continuous and 4 h infusion of amphotericin B: a comparative study involving high-risk haematology patients." J Antimicrob Chemother 54 (2004): 803-8

22. Branch R, Jackson E, Jacqz E, et al "Amphotericin-B nephrotoxicity in humans decreased by sodium supplements with coadministration of ticarcillin or intravenous saline." Klin Wochenschr 65 (1987): 500-6

23. Patterson R, Ackerman G "Renal tubular acidosis due to amphotericin B nephrotoxicity." Arch Intern Med 127 (1971): 241-4

24. Saag MS, Powderly WG, Cloud GA, et al "Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis." N Engl J Med 326 (1992): 83-9

25. Wingard JR, Kubilis P, Lee L, Yee G, White M, Walshe L, Bowden R, Anaissie E, Hiemenz J, Lister J "Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis." Clin Infect Dis 29 (1999): 1402-7

26. Fischer J, Dewald J "Parkinsonism associated with intraventricular amphotericin B." J Antimicrob Chemother 12 (1983): 97-9

27. Klibanov OM, Raasch RH, Rublein JC "Changes in renal function after changes in antifungal drug therapy." Am J Health Syst Pharm 61 (2004): 50-3

28. Bates DW, Su L, Yu DT, Chertow GM, Seger DL, Gomes DRJ, Dasbach EJ, Platt R "Mortality and costs of acute renal failure associated with amphotericin B therapy." Clin Infect Dis 32 (2001): 686-93

29. Sacks P, Fellner S "Recurrent reversible acute renal failure from amphotericin." Arch Intern Med 147 (1987): 593-5

30. Eriksson U, Seifert B, Schaffner A "Comparison of effects of amphotericin B deoxycholate infused over 4 or 24 hours: randomised controlled trial." Br Med J 322 (2001): 579-82

31. Cleary J, Weisdorf D, Fletcher C "Effect of infusion rate on amphotericin B-associated febrile reactions." Drug Intell Clin Pharm 22 (1988): 769-72

32. Rosch J, Pazin G, Fireman P "Reduction of amphotericin B nephrotoxicity with mannitol." JAMA 235 (1976): 1995-6

33. Barton C, Pahl M, Vaziri N, Cesario T "Renal magnesium wasting associated with amphotericin B therapy." Am J Med 77 (1984): 471-4

34. Arning M, Scharf R, Schneider W "Prevention of renal failure during long-term treatment with amphotericin-B." Klin Wochenschr 65 (1987): 1108

35. Maddux M, Barriere S "A review of complications of amphotericin B therapy: recommendations for prevention and management." Drug Intell Clin Pharm 14 (1980): 177-81

36. Branch R "Prevention of amphotericin B-induced renal impairment: a review on the use of sodium supplementation." Arch Intern Med 148 (1988): 2389-94

37. Barlows TG, Luber AD, Jacobs RA, Guglielmo BJ "Hypothermia following the intravenous administration of amphotericin B." Clin Infect Dis 23 (1996): 1187-8

38. Marcus N, Garty BZ "Transient hypoparathyroidism due to amphotericin B-induced hypomagnesemia in a patient with beta-thalassemia." Ann Pharmacother 35 (2001): 1042-4

39. Wazny LD, Brophy DF "Amiloride for the prevention of amphotericin B-induced hypokalemia and hypomagnesemia." Ann Pharmacother 34 (2000): 94-7

40. Miller R, Bates J "Amphotericin B toxicity." Ann Intern Med 71 (1969): 1089-95

41. Miller M "Reversible hepatotoxicity related to amphotericin B." Can Med Assoc J 131 (1984): 1245-7

42. Roncoroni A, Corrado C, Besuschio S, Pavlovsky S, Narvaiz M "Bronchiolitis obliterans possibly associated with amphotericin B." J Infect Dis 161 (1990): 589

43. Saklayen M "CAPD peritonitis: incidence, pathogens, diagnosis, and management." Med Clin North Am 74 (1990): 997-1010

44. Chan CS, Tuazon CU, Lesin LS "Amphotericin-B-induced thrombocytopenia." Ann Intern Med 96 (1982): 332-3

45. Struijk D, Krediet R, Boeschoten E, Rietra JG, Arisz L "Antifungal treatment of candida peritonitis in continuous ambulatory peritoneal dialysis patients." Am J Kidney Dis 9 (1987): 66-70

46. Weddington W "Delirium and depression associated with amphotericin B." Psychosomatics 23 (1982): 1076-8

47. Kan V, Bennett J, Amantea M, et al "Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B desoxycholate in healthy male volunteers." J Infect Dis 164 (1991): 418-21

48. Ellis WG, Sobel RA, Nielsen LS "Leukoencephalopathy in patients treated with amphotericin B methylester." J Infect Dis 146 (1982): 125-37

49. Carnevale NT, Galgiani JN, Stevens DA, Herrick MK, Langston JW "Amphotericin B-induced myelopathy." Arch Intern Med 140 (1980): 1189-92

50. Li P, Lai K "Amphotericin B-induced ocular toxicity in cryptococcal meningitis." Br J Ophthalmol 73 (1989): 397-8

51. Aruna AS, Al-Samarrai SA, Al-Humaidan AS "Amphotericin B-induced seizures in a patient with AIDS." Ann Pharmacother 35 (2001): 1037-41

52. Giglioitti F, Shenep J, Lott L, Thornton D "Induction of prostaglandin synthesis as the mechanism responsible for the chills and fever produced by infusing amphotericin B." J Infect Dis 156 (1987): 784-9

53. Heinemann C, Wiesend CL, Hipler C, Norgauer J, Ziemer M "Acute generalized exanthematous pustulosis (AGEP) after oral use of amphotericin B." J Am Acad Dermatol 57(2 Suppl) (2007): S61-3

54. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4

55. Dules CS, Perfect JR "Amphotericin B-induced malignant hypertensive episodes." J Infect Dis 161 (1990): 588

56. DeMonaco HJ, McGovern B "Transient asystole associated with amphotericin B infusion." Drug Intell Clin Pharm 17 (1983): 547-8

57. Craven P, Gremillion D "Risk factors of ventricular fibrillation during rapids amphotericin B infusion." Antimicrob Agents Chemother 27 (1985): 868-71

58. Katz BZ, Cohn RA "Amphotericin b and hypertension." Pediatr Infect Dis J 13 (1994): 839-40

59. Le Y, rana KZ, Dudley MN "Amphotericin B-associated hypertension." Ann Pharmacother 30 (1996): 765-7

60. Le Y, Rana KZ, Dudley MN "Amphotericin b-associated hypertension." Ann Pharmacother 30 (1996): 765-7

61. Levine S, Walsh T, Martinez A, Eichacker PA, Lopez-Berestein G, Natanson "Cardiopulmonary toxicity after liposomal amphotericin B infusion." Ann Intern Med 114 (1991): 664-6

62. Haber R, Oddone E, Gurbel P, Stead W "Acute pulmonary decompensation due to amphotericin B in the absence of granulocyte transfusions." N Engl J Med 215 (1986): 836

63. Krimerman SM, Potasman I, Barak A "Pulmonary reactions associated with the combined use of amphotericin B and leukocyte transfusions." Crit Care Med 17 (1989): 1081

64. Gill J, Sprenger HR, Ralph ED, Sharpe MD "Hepatotoxicity possibly caused by amphotericin B." Ann Pharmacother 33 (1999): 683-5

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.

Hide
(web2)