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Gemzar Side Effects

Generic Name: gemcitabine

Note: This document contains side effect information about gemcitabine. Some of the dosage forms listed on this page may not apply to the brand name Gemzar.

For the Consumer

Applies to gemcitabine: intravenous powder for solution, intravenous solution

Along with its needed effects, gemcitabine (the active ingredient contained in Gemzar) 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 immediately if any of the following side effects occur while taking gemcitabine:

More common
  • Bleeding gums
  • blood in urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cloudy urine
  • coughing up blood
  • cough or hoarseness
  • diarrhea
  • difficult or labored breathing
  • difficulty in moving
  • difficulty in swallowing
  • dizziness
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • increased menstrual flow or vaginal bleeding
  • joint pain
  • lack or loss of strength
  • loss of appetite
  • lower back or side pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • paralysis
  • pinpoint red spots on skin
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • runny nose
  • shivering
  • shortness of breath
  • sores, ulcers, or white spots on lips or in mouth
  • sore throat
  • sweating
  • swelling of hands, ankles, feet, or lower legs
  • swollen glands
  • swollen joints
  • tightness in chest
  • troubled breathing with exertion
  • trouble sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight loss
  • wheezing
Less common
  • Blurred vision
  • chest discomfort
  • fainting
  • fast, slow, or irregular heartbeat
  • headache (sudden and severe)
  • inability to speak
  • nervousness
  • noisy breathing
  • pain or discomfort in arms, jaw, back or neck
  • pounding in the ears
  • seizures
  • slurred speech
  • temporary blindness
  • weakness in arm and/or leg on one side of the body (sudden and severe)
  • Confusion
  • lightheadedness
  • rapid, shallow breathing
Incidence not determined
  • Hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • skin rash

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
  • Difficulty having a bowel movement (stool)
  • hair loss
  • pain
  • sleepiness or unusual drowsiness
  • swelling or inflammation of the mouth
  • thinning of hair
Less common
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

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.[Ref]

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[Ref]


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 (the active ingredient contained in Gemzar) 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]


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]

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]

Nervous system

Common (1% to 10%): Headache, insomnia, somnolence, paraesthesia
Uncommon (0.1% to 1%): Cerebrovascular accident
Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)[Ref]

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


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Some side effects of Gemzar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.