Summary
Commonly reported side effects of ganciclovir include: severe neutropenia, severe thrombocytopenia, anemia, leukopenia, neutropenia, and decreased creatinine clearance. Other side effects include: severe anemia. Continue reading for a comprehensive list of adverse effects.
Applies to ganciclovir: powder for solution, solution.
Warning
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
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]
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]
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
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]
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]
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
Retinal detachment has been observed both before and after initiation of therapy in patients with CMV retinitis; its relationship to therapy is unknown.[Ref]
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]
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,
other catheter related events
Frequency not reported: Injection site inflammation[Ref]
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]
