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Gemcitabine Side Effects

Medically reviewed by Last updated on Jul 5, 2023.

Applies to gemcitabine: intravenous powder for solution, intravenous solution.

Serious side effects of Gemcitabine

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

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

More common

Less common


Incidence not known

Other side effects of Gemcitabine

Some side effects of gemcitabine 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

For Healthcare Professionals

Applies to gemcitabine: intravenous powder for injection, intravenous solution.


Very common (10% or more): Anemia (68%), neutropenia (63%), leucopenia (62%), thrombocytopenia (24%), petechiae (16%), hemorrhage (17%), bone marrow suppression (usually mild to moderate)

Common (1% to 10%): Febrile neutropenia

Very rare (less than 0.01%): Thrombocytosis

Postmarketing reports: Capillary leak syndrome (CLS)[Ref]

Myelosuppression is the major dose-limiting factor associated with gemcitabine therapy.

Dosage adjustments for hematologic toxicity are frequently necessary. Less than 1% of patients have had to discontinue therapy for either anemia, leukopenia, or thrombocytopenia. Grade 3/4 thrombocytopenia was more common in the elderly, especially older women.

The risk for thrombotic thrombocytopenic purpura increases as the cumulative dose of gemcitabine approaches 20,000 mg/m2.[Ref]


Very common (10% or more): Nausea/vomiting (69%), diarrhea (19%), stomatitis (11%), stomatitis and ulceration of the mouth (11%)

Common (1% to 10%): Constipation

Very rare (less than 0.01%): Ischemic colitis, anal pruritus[Ref]

If the patient is not vomiting due to their disease state, nausea can generally be prevented by administration of prochlorperazine or low-dose oral serotonin antagonists and glucocorticoid therapy. One study of 790 patients found the rate of WHO grade 3 nausea and vomiting at a frequency of 22% in patients under 65 years of age, and 12% in patients 65 years of age or older.[Ref]


No evidence of increased hepatic toxicity has been reported with longer duration or greater total cumulative dose.

Very common (10% or more): Increased ALT (68%), increased AST (67%), increased alkaline phosphatase (55%), hyperbilirubinemia (13%)

Common (1% to 10%):

Uncommon (0.1% to 1%): Serious hepatotoxicity (including liver failure and death), increased gamma-glutamyl transferase (GGT)

Postmarketing reports: Hepatic veno-occlusive disease


Renal failure may not be reversible, even upon discontinuation of therapy.[Ref]

Very common (10% or more): Proteinuria (45%), hematuria (35%), increased BUN (16%)

Common (1% to 10%): Increased creatinine (8%)

Uncommon (0.1% to 1%): Renal failure, hemolytic-uremic syndrome[Ref]


The flu-like symptoms usually take place a few hours after drug administration. The symptoms are usually self-limiting and recovery is generally within 24 to 48 hours. Less than 1% of patients discontinued use due to flu-like symptoms. Some patients get relief from nonsteroidal anti-inflammatory drugs or acetaminophen.

Out of the five reported cases of distal ischemic changes, four of those case related to combination chemotherapy with cisplatin and gemcitabine, while one case was of gemcitabine as a single agent in first-line therapy.[Ref]

Very common (10% or more): Fever (41%), asthenia, chills

Common (1% to 10%): Paresthesia

Rare (less than 0.1%): Radiation toxicity, radiation recall

Frequency not reported: Cough, chills, pattern of tissue injury typically associated with radiation toxicity[Ref]


Rash was generally a macular or finely granular maculopapular pruritic eruption, mild to moderate in severity, involving the trunk and extremities. Alopecia is usually minimal.[Ref]

Very common (10% or more): Allergic skin rash frequently associated with pruritus (30%), alopecia (15%)

Common (1% to 10%): Itching, sweating

Rare (0.01% to 0.1%): Severe skin reactions (including desquamation and bullous skin eruptions), ulceration, vesicle and sore formation, scaling

Very rare (less than 0.01%): Lyell's syndrome (toxic epidermal necrolysis, Stevens Johnson Syndrome

Postmarketing reports: Cellulitis[Ref]


Some of the dyspnea reported may have been due to underlying disease. Forty percent of the study population consisted of lung cancer patients, while some of the other study patients had pulmonary manifestations of other malignancies.

Different patterns of lung injury may be related to gemcitabine. A rapid response following the administration of corticosteroids would mean the respiratory problem was probably due to a hypersensitivity reaction.[Ref]

Very common (10% or more): Dyspnea (23%)

Common (1% to 10%): Cough, rhinitis

Uncommon (0.1% to 1%): Interstitial pneumonitis, bronchospasm

Rare (0.01% to 0.1%): Pulmonary edema, adult respiratory distress syndrome (ARDS)

Very rare (less than 0.01%): Respiratory failure/death

Frequency not reported: Pulmonary fibrosis, pulmonary edema[Ref]

Nervous system

Less than 1% of the paresthesias have been severe.[Ref]

Common (1% to 10%): Headache, insomnia, somnolence, paraesthesia

Uncommon (0.1% to 1%): Cerebrovascular accident

Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)[Ref]


Very common (10% or more): Injection site reactions (mainly mild)[Ref]


Rare (less than 0.1%): Hypersensibility[Ref]


Many of the patients that suffered cardiovascular effects had a prior history of cardiovascular disease. Two percent of patients discontinued therapy due to these effects. Less than 1% of patients discontinued due to edema.[Ref]

Uncommon (0.1% to 1%): Arrhythmias (predominantly supraventricular), heart failure

Rare (less than 0.1%): Hypotension, hypertension, myocardial infarction, atrial fibrillation

Very rare (less than 0.01%): Congestive heart failure

Postmarketing reports: Supraventricular arrhythmias[Ref]


Very common (10% or more): Infection (16%), influenza-like symptoms

Rare (less than 0.1%): Anaphylactoid reaction

Frequency not reported: Scleroderma-like reaction[Ref]


Very common (10% or more): Edema/peripheral edema-including facial edema (usually reversible after stopping treatment)

Common (1% to 10%): Anorexia[Ref]


Common (1% to 10%): Back pain, myalgia[Ref]


1. Product Information. Gemcitabine (gemcitabine). Mylan Institutional LLC. 2019.

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.