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Gastro-intestinal: Nausea and nausea accompanied by vomiting are each reported in about one-third of patients, respectively. This adverse event requires therapy, is rarely dose-limiting and is easily manageable with standard antiemetics.
Renal: Mild proteinuria and hematuria are reported in approximately half the patients, but are rarely clinically significant, and are not usually associated with any change in serum creatinine or blood urea nitrogen. However, a few cases of renal failure of uncertain aetiology have been reported, including in very rare instances, cases of haemolytic uraemic syndrome (HUS) in patients receiving Gemcitabine. Hence, Gemcitabine should be used with caution in patients with impaired renal function.
Allergic: Anaphylaxis has been reported rarely.
Respiratory: Bronchospasm after Gemcitabine infusion has been reported and bronchospasm is usually mild and transient, but parenteral therapy may be required. Gemcitabine should not be administered to patients with a known hypersensitivity to this drug.
Dyspnoea occurring within hours following Gemcitabine injection is reported and is usually mild, short lived, rarely dose-limiting, and usually abates without any specific therapy. The mechanism of this event is unknown and the relationship to Gemcitabine is not clear. Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis, or adult respiratory distress syndrome - ARDS) have been reported rarely in association with Gemcitabine therapy.
Hepatobiliary system: Abnormalities of liver transaminase enzymes (AST and ALT) and alkaline phosphatase occur in about two-thirds of patients, but they are usually mild, non-progressive and rarely necessitate stopping treatment. However, Gemcitabine should be used with caution in patients with impaired liver function. Elevation in gamma-glutamyl transferase (GGT) and bilirubin levels have been reported rarely.
Injury, poisoning and procedural complications: Radiation toxicity and radiation recall reactions have been reported.
Cardiovascular: A few cases of hypotension were reported. Cases of myocardial infarction, congestive heart failure and arrhythmia have been reported, but there is no clear evidence that Gemcitabine causes cardiac toxicity.
Vascular system: Peripheral vasculitis and gangrene, and capillary leak syndrome have been reported very rarely.
Skin and subcutaneous tissue: A rash is seen in patients and is associated with pruritus in patients. The rash is usually mild, not dose-limiting and responds to local therapy. Desquamation, vesiculation and ulceration have been reported rarely. Severe skin reactions, including desquamation and bullous skin eruptions have been reported very rarely.
Nervous system: Posterior reversible encephalopathy syndrome has been reported very rarely.
Others: An entity resembling is reported. This is usually mild, short-lived and rarely dose-limiting. Fever, headache, back pain, chills, myalgia, asthenia and anorexia are the most commonly reported symptoms. Cough, rhinitis, malaise, sweating and insomnia are also commonly reported. Fever and asthenia are also reported frequently as isolated symptoms. The mechanism of this toxicity is unknown. Reports received indicate that Paracetamol may produce symptomatic relief.
Oedema/peripheral oedema is reported. Some cases of facial edema have also been reported. Oedema/peripheral oedema is usually mild to moderate, rarely dose-limiting, is sometimes reported as painful and is usually reversible after stopping Gemcitabine treatment. The mechanism of this toxicity is unknown. It is not associated with any evidence of cardiac, hepatic or renal failure.
The following adverse effect are also commonly reported: Alopecia (usually minimal hair loss), somnolence, diarrhea, oral toxicity (mainly soreness and erythema) and constipation.
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