Ganciclovir Side Effects

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Applies to ganciclovir: powder for solution, solution.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

The clinical toxicity of ganciclovir includes granulocytopenia, anemia, and thrombocytopenia.

Ganciclovir capsules are indicated only for prevention of cytomegalovirus (CMV) disease in patients with advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients.

Because ganciclovir is associated with a risk of more rapid rate of CMV retinitis progression, it should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily IV infusions.

Intravenous route (powder for solution)

Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir sodium.

Based on animal data and limited human data, ganciclovir sodium may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.

Based on animal data, ganciclovir sodium has the potential to cause birth defects in humans.

Based on animal data, ganciclovir sodium has the potential to cause cancers in humans.

Serious side effects of ganciclovir

Along with its needed effects, ganciclovir 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 ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

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

More common

For oral capsules and injection into the vein only

• sore throat and fever
• unusual bleeding or bruising

Less common

For oral capsules and injection into the vein only

• mood or other mental changes
• nervousness
• pain at place of injection
• skin rash
• tremor
• unusual tiredness and weakness

For injection into the eye only

• decreased vision or any change in vision

Other side effects of ganciclovir

Some side effects of ganciclovir 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:

Less common

• abdominal or stomach pain
• loss of appetite
• nausea and vomiting

For healthcare professionals

Applies to ganciclovir: intravenous powder for injection, intravenous solution, oral capsule.

General

The most commonly reported adverse events have included pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, dyspnea, abdominal pain, decreased appetite, and increased creatinine.^[Ref]

Hematologic

• Very common (10% or more): Leukopenia (up to 41%), anemia (up to 26%), neutropenia (up to 26%)
• Common (1% to 10%): Thrombocytopenia, lymphadenopathy
• Uncommon (0.1% to 1%): Bone marrow failure
• Frequency not reported: Pancytopenia
• Postmarketing reports: Hemolytic anemia, agranulocytosis, granulocytopenia^[Ref]

During clinical trials for the treatment of CMV retinitis, neutropenia with absolute neutrophil count (ANC) less than 500, between 500 and 749, and 750 to less than 1000 mcL, was reported in 25%, 14%, and 26% of patients, respectively. Anemia with hemoglobin less than 6.5, between 6.5 and less than 8, and 8 to less than 9.5 g/dL was reported in 5%, 16%, and 26% of patients, respectively.

During clinical trials among transplant recipients receiving this drug for CMV prevention, neutropenia with absolute neutrophil count (ANC) less than 500, between 500 and 1000 mcL, and total ANC of 1000 mcL or less was reported in 4%, 3% and 7% of heart transplant recipients and 12%, 29%, and 41% of bone marrow transplant recipients, respectively. Thrombocytopenia with platelet counts less than 25,000 and between 25,000 and 50,000 mcL were reported in 3% and 5% and 32% and 25% of heart and bone marrow recipients, respectively. Total platelet count of 50,000 mcL or less was reported in 8% and 57% of heart and bone marrow recipients, respectively.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 44%), vomiting 13%
• Common (1% to 10%): Nausea, abdominal pain, constipation, flatulence, esophageal candidiasis, dysphagia, dyspepsia
• Uncommon (0.1% to 1%): Mouth ulceration, abdominal distention, pancreatitis
• Frequency not reported: Gastrointestinal perforation, eructation, dry mouth, pancreatitis
• Postmarketing reports: Intestinal ulcer^[Ref]

Renal

• Very common (10% or more): Elevated serum creatinine
• Frequency not reported: Kidney failure, abnormal renal function, pleural effusion
• Postmarketing reports: Renal tubular disorder, hemolytic uremic syndrome^[Ref]

Elevated serum creatinine between greater than 1.5 and less than 2.5 mg/dL was reported in 14% of patients receiving 5 mg/kg/day for treatment of CMV retinitis; 2% experienced elevated serum creatinine of 2.5 mg/dL or greater.

Elevated serum creatinine between greater than 1.5 and less than 2.5 mg/dL was reported in 58%, 50%, and 43% of patients receiving this drug for CMV prevention in heart, and 2 bone marrow trials, respectively; 18%, 20%, and 0% experienced serum creatinine levels of 2.5 mg/dL or higher.^[Ref]

Genitourinary

• Frequency not reported: Urinary tract infection, urinary frequency, hematuria
• Postmarketing reports: Testicular hypertrophy^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity
• Postmarketing reports: Anaphylactic reaction, allergic reaction^[Ref]

Ocular

• Very common (10% or more): Retinal detachment (11%)
• Common (1% to 10%): Eye hemorrhage, macular edema, vitreous floaters, eye pain
• Frequency not reported: Visual impairment, vitreous disorders, eye pain, conjunctivitis
• Postmarketing reports: Cataracts, dry eyes^[Ref]

Retinal detachment has been observed both before and after initiation of therapy in patients with CMV retinitis; its relationship to therapy is unknown.^[Ref]

Cardiovascular

• Very common (10% or more): Tachycardia (16%), hypotension (11%)
• Frequency not reported: Arrhythmias, chest pain, hypertension, phlebitis, vasodilation
• Postmarketing reports: Cardiac arrest, conduction disorder, torsade de pointes, ventricular tachycardia, peripheral ischemia^[Ref]

Cases of ventricular tachycardia associated with ganciclovir infusions in patients with AIDS have been reported, although it is known that HIV infection is associated with myocarditis, decreased left ventricular function, and in some cases, nonsustained ventricular tachycardia.^[Ref]

Dermatologic

• Very common (10% or more): Hyperhidrosis (12%)
• Common (1% to 10%): Pruritus, dermatitis, night sweats
• Frequency not reported: Cellulitis, alopecia, dry skin, urticaria, rash, photosensitivity reaction
• Postmarketing reports: Exfoliative dermatitis, Stevens-Johnson syndrome^[Ref]

Hepatic

• Common (1% to 10%): Increased alkaline phosphatase
• Frequency not reported: Abnormal hepatic function tests, increased transaminases
• Postmarketing reports: Cholelithiasis, cholestasis, hepatic failure, hepatitis^[Ref]

Nervous system

• Very common (10% or more): Headache (15%)
• Common (1% to 10%): Peripheral neuropathy, tremor, dizziness, paresthesia, hypoesthesia, seizures, dysgeusia
• Frequency not reported: Somnolence
• Postmarketing reports: Dysesthesia, dysphasia, extrapyramidal disorder, facial paralysis, amnesia, anosmia, myelopathy, cerebrovascular accident, third cranial nerve paralysis, aphasia, encephalopathy, intracranial hypertension, facial palsy^[Ref]

Endocrine

• Postmarketing reports: Inappropriate antidiuretic hormone secretion, infertility^[Ref]

Local

• Common (1% to 10%): Catheter infection, catheter sepsis, injection site inflammation,
• Frequency not reported: Injection site inflammation^[Ref]

other catheter related events

Metabolic

• Very common (10% or more): Decreased appetite (14%), decreased blood magnesium (11%)
• Common (1% to 10%): Decreased weight, anorexia
• Frequency not reported: Hypocalcemia, hypokalemia, hyperglycemia
• Postmarketing reports: Acidosis, hypercalcemia, hyponatremia, increased blood triglycerides^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia, back pain, muscle spasms
• Frequency not reported: Leg cramps, myasthenia
• Postmarketing reports: Arthritis, rhabdomyolysis^[Ref]

Respiratory

• Very common (10% or more): Cough (16%)
• Common (1% to 10%): Pneumocystis carinii pneumonia, sinus congestion, rhinitis, dyspnea
• Frequency not reported: Upper respiratory infection
• Postmarketing reports: Bronchospasm, pulmonary fibrosis^[Ref]

Other

• Very common (10% or more): Pyrexia (up to 48%)
• Common (1% to 10%): Chills
• Uncommon (0.1% to 1%): Deafness
• Frequency not reported: Tinnitus, ear pain, fatigue, pain, malaise, asthenia, multiple organ failure
• Postmarketing reports: Congenital anomaly, loss of sense of smell^[Ref]

Immunologic

• Very common (10% or more): Sepsis (15%), infection (13%)
• Common (1% to 10%): Mycobacterium avium complex
• Frequency not reported: Candida infections, influenza
• Postmarketing reports: Vasculitis^[Ref]

Further information

Ganciclovir side effects can vary depending on the individual. 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.

Medical Disclaimer