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Cidofovir Side Effects

In Summary

Commonly reported side effects of cidofovir include: decreased creatinine clearance, hypotony of eye, increased serum creatinine, nephrotoxicity, neutropenia, and proteinuria. Other side effects include: decreased serum bicarbonate. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to cidofovir: intravenous solution

Along with its needed effects, cidofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like cidofovir can sometimes cause serious side effects such as blood problems and kidney problems; these are described below. Cidofovir has also been found to cause cancer in animals, and there is a chance it could cause cancer in humans as well. Discuss these possible side effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking cidofovir:

More Common

Check with your doctor as soon as possible if any of the following side effects occur while taking cidofovir:

More Common

  • Decreased urination
  • increased thirst and urination

Rare

  • Decreased vision or any change in vision

Some side effects of cidofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Generalized weakness
  • loss of strength

For Healthcare Professionals

Applies to cidofovir: intravenous solution

General

The most commonly reported adverse events include proteinuria, increased serum creatinine, neutropenia, decreased serum bicarbonate, decreased intraocular pressure, fever, and infection.[Ref]

Renal

Very common (10% or more): Proteinuria (up to 88%), elevated creatinine (up to 24%), nephrotoxicity (up to 59%)

Frequency not reported: Increased BUN[Ref]

Nephrotoxicity may be irreversible. Renal impairment, including cases of acute renal failure resulting in dialysis and/or contributing to death, has occurred with as few as one or two doses of the drug. Proteinuria (greater than 2+), reduced creatinine clearance (less than or equal to 55 mL/min), and/or elevations of serum creatinine concentration (greater than 0.4 mg/dL) occurred in about 59% of patients receiving a maintenance dose of 5 mg/kg every other week. Toxic nephropathy has also been reported.[Ref]

Ocular

The risk of ocular hypotony may be increased in patients with diabetes mellitus.

Uveitis or iritis was reported in 15 (11%) of 135 patients who were administered the 5 mg/kg maintenance dose. Patients should be monitored for signs and symptoms of these complications and if they develop, treatment with topical corticosteroids with or without topical cycloplegic agents may be useful.[Ref]

Very common (10% or more): Anterior uveitis/iritis (11%); decreased intraocular pressure (24%)

Rare (0.01% to 0.1%): Ocular hypotony

Frequency not reported: Abnormal vision, amblyopia, blindness, cataract, conjunctivitis, corneal lesion, corneal opacity, diplopia, dry eyes, eye pain, iritis, keratitis, refraction disorder, retinal detachment, retinal disorder, uveitis, visual field defect, miosis[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 23%), decreased serum bicarbonate (16%)

Common (1% to 10%): Fanconi-like syndrome

Frequency not reported: Weight loss, weight gain, thirst, respiratory alkalosis, hyperkalemia, hypophosphatemia, hypokalemia, hypomagnesemia, hyperglycemia, dehydration, hypocalcemia, cachexia, hypercalcemia, hyperlipidemia, hypoglycemia, hypoglycemic reaction, hyponatremia, hypoproteinemia, metabolic acidosis[Ref]

Genitourinary

Frequency not reported: Glycosuria[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 43%), anemia (up to 24%)

Frequency not reported: Hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphoma like reaction, pancytopenia, splenic disorder, splenomegaly, thrombocytopenia, thrombocytopenic purpura[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, allergic reaction[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 69%), diarrhea (up to 26%). oral moniliasis (up to 18%)

Common (1% to 10%): Nausea with vomiting

Frequency not reported: Dyspepsia, constipation, abdominal pain, cholangitis, colitis, esophagitis, dysphagia, fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage, gingivitis, melena, pancreatitis, proctitis, rectal disorder, stomatitis, aphthous stomatitis, tongue discoloration, mouth ulceration, tooth caries, dry mouth[Ref]

Administration of probenecid after a meal and/or therapy with antiemetics may alleviate the nausea and vomiting associated with probenecid.[Ref]

Cardiovascular

Frequency not reported: Cardiomyopathy, cardiovascular disorder, congestive heart failure, hypertension, hypotension, peripheral vascular disorder, phlebitis, postural hypotension, shock, syncope, tachycardia, vascular disorder, edema, chest pain[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 27%), rash (up to 30%)

Frequency not reported: Cellulitis, cyst, face edema, photosensitivity reaction, acne, angioedema, dry skin, eczema, exfoliative dermatitis, furunculosis, herpes, simplex nail disorder, pruritus, rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin ulcer, sweating, urticaria[Ref]

Local

Frequency not reported: Blocked catheter, injection site reaction[Ref]

Endocrine

Frequency not reported: Adrenal cortex insufficiency[Ref]

Hepatic

Frequency not reported: Hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, abnormal liver function, liver damage, liver necrosis, increased transaminases, increased alkaline phosphatase, increased lactic dehydrogenase[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthrosis, bone necrosis, bone pain, joint disorder, leg cramps, myalgia, myasthenia, pathological fracture, neck pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 30%)

Frequency not reported: Acute brain syndrome, cerebrovascular disorder, convulsion, delirium, dementia, dizziness, encephalopathy, facial paralysis, hemiplegia, hyperesthesia, hypertonia, hypotony, incoordination, myoclonus, neuropathy, paresthesia, somnolence, tremor, twitching, ataxia, taste perversion, speech disorder, abnormal gait, peripheral neuritis[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 23%), increased cough (up to 19%)

Frequency not reported: Asthma, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, increased sputum, larynx edema, lung disorder, pharyngitis, pneumothorax, rhinitis, sinusitis, hyperventilation[Ref]

Other

Very common (10% or more): Fever (up to 58%), asthenia (up to 43%), chills (up to 22%)

Frequency not reported: Ear disorder, ear pain, hyperacusis, otitis externa, otitis media, tinnitus, hearing loss, vertigo, malaise[Ref]

Immunologic

Very common (10% or more): Infection (up to 28%)

Frequency not reported: Sepsis, flu-like syndrome

Psychiatric

Frequency not reported: Abnormal dreams, agitation, amnesia, anxiety, confusion, depression, drug dependence, insomnia, personality disorder

References

1. "Product Information. Vistide (cidofovir)." Gilead Sciences, Foster City, CA.

2. Segarra-Newnham M, Vodolo KM "Use of cidofovir in progressive multifocal leukoencephalopathy." Ann Pharmacother 35 (2001): 741-4

3. Lalezari JP, Drew WL, Glutzer E, James C, Miner D, Flaherty J, Fisher PE, Cundy K, Hannigan J, Martin JC, et al "(S)-1-[3-hydroxy-2-(phosphonylmethoxy)propyl]cytosine (cidofovir): results of a phase I/II study of a novel antiviral nucleotide analogue." J Infect Dis 171 (1995): 788-96

4. Plosker GL, Noble S "Cidofovir - A review of its use in cytomegalovirus retinitis in patients with AIDS." Drugs 58 (1999): 325-45

5. Szczech LA "Hypertension and medication-related renal dysfunction in the HIV-infected patient." Semin Nephrol 21 (2001): 386-93

6. Wald A "New therapies and prevention strategies for genital herpes." Clin Infect Dis 28 (1999): s4-13

7. Roling J, Schmid H, Fischereder M, Draenert R, Goebel FD "HIV-Associated Renal Diseases and Highly Active Antiretroviral Therapy-Induced Nephropathy." Clin Infect Dis 42 (2006): 1488-95

8. Torgovnick J, Sethi N, Karter D, Arsura E "Remission of AIDS-associated progressive multifocal leukoencephalopathy with combined cidofovir and radiotherapy: a case report." AIDS 20 (2006): 1569-1570

9. Izzedine H, Launay-Vacher V, Deray G "Renal tubular transporters and antiviral drugs: an update." AIDS 19 (2005): 455-62

10. Yusuf U, Hale GA, Carr J, et al. "Cidofovir for the Treatment of Adenoviral Infection in Pediatric Hematopoietic Stem Cell Transplant Patients." Transplantation 81 (2006): 1398-1404

11. Kazory A, Singapuri S, Wadhwa A, Ejaz AA "Simultaneous development of Fanconi syndrome and acute renal failure associated with cidofovir." J Antimicrob Chemother 60 (2007): 193-4

12. Jabs DA "The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The ganciclovir cidofovir cytomegalovirus retinitis trial." Am J Ophthalmol 131 (2001): 457-67

13. Shehab N, Sweet BV, Hogikyan ND "Cidofovir for the treatment of recurrent respiratory papillomatosis: a review of the literature." Pharmacotherapy 25 (2005): 977-89

14. Perazella MA "Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity." Am J Med Sci 325 (2003): 349-62

15. Polis MA, Spooner KM, Baird BF, Manischewitz JF, Jaffe HS, Fisher PE, Falloon J, Davey RT Jr, Kovacs JA, Walker RE, et al "Anticytomegaloviral activity and safety of cidofovir in patients with human immunodeficiency virus infection and cytomegalovirus viruria." Antimicrob Agents Chemother 39 (1995): 882-6

16. Lopez V, Sola E, Gutierrez C, et al. "Anterior Uveitis Associated With Treatment With Intravenous Cidofovir in Kidney Transplant Patients With BK Virus Nephropathy." Transplant Proc 38 (2006): 2412-2413

17. Izzedine H, Launay-Vacher V, Deray G "Antiviral drug-induced nephrotoxicity." Am J Kidney Dis 45 (2005): 804-17

18. Chakrabarti S, Collingham KE, Osman H, Fegan CD, Milligan DW "Cidofovir as primary pre-emptive therapy for post-transplant cytomegalovirus infections." Bone Marrow Transplant 28 (2001): 879-81

19. Cabello V, Margarit N, Diaz Pedrero M, Bernal G, Pereira P, Gentil MA "Treatment of BK Virus-Associated Nephropathy With Cidofovir in Renal Transplantation." Transplant Proc 40 (2008): 2930-2

20. Akler ME, Johnson DW, Burman WJ, Johnson SC "Anterior uveitis and hypotony after intravenous cidofovir for the treatment of cytomegalovirus retinitis." Ophthalmology 105 (1998): 651-7

21. Neau D, RenaudRougier MB, Viallard JF, Dutronc H, Cazorla C, Ragnaud JM, Dupon M, Lacut JY "Intravenous cidofovir-induced iritis." Clin Infect Dis 28 (1999): 156-7

22. Tseng AL, Mortimer CB, Salit IE "Iritis associated with intravenous cidofovir." Ann Pharmacother 33 (1999): 167-71

23. Friedberg DN "Hypotony and visual loss with intravenous cidofovir treatment of cytomegalovirus retinitis." Arch Ophthalmol 115 (1997): 801-2

24. Kay TD, Hogan PG, McLeod S, Johnson DW "Severe irreversible proximal renal tubular acidosis and azotaemia secondary to cidofovir." Nephron 86 (2000): 348-9

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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