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Gemcitabine Side Effects

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Common Gemcitabine Side Effects


The most commonly reported Gemcitabine side effects (click to view or check a box to report):

Nausea (222)
Anaemia (193)
Dyspnoea (187)
Pneumonia (179)
Vomiting (177)
Pyrexia (172)
Thrombocytopenia (171)
Dehydration (146)
Neutropenia (145)
Diarrhoea (132)
Asthenia (124)
Abdominal Pain (119)
Fatigue (113)
Disease Progression (109)
Haemoglobin Decreased (108)
Renal Failure Acute (107)
Pulmonary Embolism (93)
Malignant Neoplasm Progression (89)
Febrile Neutropenia (88)
Pleural Effusion (87)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Gemcitabine Side Effects Reported to FDA



Gemcitabine Side Effect Report#9994668
Fall, Balance Disorder, Head Injury, Pleural Effusion, Atelectasis, Pericardial Effusion, Ascites, Agitation
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Gemcitabine Hydrochloride (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Fall, Balance Disorder, Head Injury, Pleural Effusion, Atelectasis, Pericardial Effusion, Ascites, Agitation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine Hydrochloride treatment in female patients, resulting in Fall side effect. The patient was hospitalized.
Gemcitabine Side Effect Report#9993477
Neutropenic Sepsis, Hypophosphataemia
This report suggests a potential Gemcitabine Hydrochloride Neutropenic Sepsis side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Gemcitabine Hydrochloride (dosage: NA) starting NS. After starting Gemcitabine Hydrochloride the patient began experiencing various side effects, including: Neutropenic Sepsis, HypophosphataemiaAdditional drugs used concurrently:
  • Ifosfamide
  • Mabthera
  • Vinorelbine
  • Aciclovir (400 Mg, Bid)
  • Allopurinol
  • Co-trimoxazol (960 Mg, 3/w)
The patient was hospitalized. Although Gemcitabine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenic Sepsis, may still occur.
Gemcitabine Side Effect Report#9992011
Cholangitis, Device Occlusion, Cholelithiasis
This Cholangitis problem was reported by a physician from CH. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pancreatic carcinoma. On NS this consumer started treatment with Gemcitabine (dosage: NA). The following drugs were being taken at the same time:
  • Eloxatin
When using Gemcitabine, the patient experienced the following unwanted symptoms/side effects: Cholangitis, Device Occlusion, CholelithiasisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cholangitis, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9989182
Tumour Lysis Syndrome, Depressed Level Of Consciousness, Anaemia, Hypercalcaemia, Hyperuricaemia, Liver Disorder, Renal Disorder
This Tumour Lysis Syndrome side effect was reported by a health professional from JP. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: metastases to bone.The patient was prescribed Gemcitabine (drug dosage: NA), which was initiated on 201103. Concurrently used drugs: NA..After starting to take Gemcitabine the consumer reported adverse symptoms, such as: Tumour Lysis Syndrome, Depressed Level Of Consciousness, Anaemia, Hypercalcaemia, Hyperuricaemia, Liver Disorder, Renal DisorderThese side effects may potentially be related to Gemcitabine. The patient was hospitalized.
Gemcitabine Side Effect Report#9988713
Tumour Lysis Syndrome, Disseminated Intravascular Coagulation
This is a report of a 59-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Gemcitabine (dosage: 1250 Mg/m2 For 14d Followed By 7-d Rest Period, start time: 201103), combined with: NA. and developed a serious reaction and side effect(s): Tumour Lysis Syndrome, Disseminated Intravascular Coagulation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine treatment in female patients, resulting in Tumour Lysis Syndrome side effect. The patient was hospitalized.
Gemcitabine Side Effect Report#9988642
Hypophosphataemia, Neutropenic Sepsis
This report suggests a potential Gemcitabine Hypophosphataemia side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Gemcitabine (dosage: NA) starting NS. After starting Gemcitabine the patient began experiencing various side effects, including: Hypophosphataemia, Neutropenic SepsisAdditional drugs used concurrently:
  • Ifosfamide
  • Mabthera
  • Vinorelbine
  • Aciclovir
  • Allopurinol
  • Co-trimoxazole
The patient was hospitalized. Although Gemcitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypophosphataemia, may still occur.
Gemcitabine Side Effect Report#9981341
Streptococcal Bacteraemia
This Streptococcal Bacteraemia problem was reported by a consumer or non-health professional from KR. A 23-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pancreatic carcinoma. On NS this consumer started treatment with Gemcitabine (dosage: NA). The following drugs were being taken at the same time: NA. When using Gemcitabine, the patient experienced the following unwanted symptoms/side effects: Streptococcal BacteraemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Streptococcal Bacteraemia, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9960735
Cystitis-like Symptom, Thrombocytopenia, Haematuria, Dysuria, Pollakiuria, Bladder Wall Calcification, Bladder Granuloma, Bladder Fibrosis, Cystitis Noninfective
This Cystitis-like Symptom side effect was reported by a physician from US. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: bladder transitional cell carcinoma.The patient was prescribed Gemcitabine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cisplatin
  • Mitomycin
.After starting to take Gemcitabine Hydrochloride the consumer reported adverse symptoms, such as: Cystitis-like Symptom, Thrombocytopenia, Haematuria, Dysuria, Pollakiuria, Bladder Wall Calcification, Bladder Granuloma, Bladder Fibrosis, Cystitis NoninfectiveThese side effects may potentially be related to Gemcitabine Hydrochloride.
Gemcitabine Side Effect Report#9927868
Erythema, Oedema, Lymphadenopathy
This is a report of a 39-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: sarcoma metastatic, who was treated with Gemcitabine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Erythema, Oedema, Lymphadenopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine treatment in male patients, resulting in Erythema side effect.
Gemcitabine Side Effect Report#9925347
Thrombotic Microangiopathy, Haemolytic Uraemic Syndrome, Oedema Peripheral, Dyspnoea, Haemodialysis
This report suggests a potential Gemcitabine Thrombotic Microangiopathy side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cholangiocarcinoma,metastasis and used Gemcitabine (dosage: NA) starting NS. After starting Gemcitabine the patient began experiencing various side effects, including: Thrombotic Microangiopathy, Haemolytic Uraemic Syndrome, Oedema Peripheral, Dyspnoea, HaemodialysisAdditional drugs used concurrently: NA. Although Gemcitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thrombotic Microangiopathy, may still occur.
Gemcitabine Side Effect Report#9924655
Visual Impairment, Retinal Vein Occlusion
This Visual Impairment problem was reported by a consumer or non-health professional from DE. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sarcoma metastatic. On
Jan 22, 2014 this consumer started treatment with Gemcitabine (dosage: NA). The following drugs were being taken at the same time:
  • Docetaxel
When using Gemcitabine, the patient experienced the following unwanted symptoms/side effects: Visual Impairment, Retinal Vein OcclusionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Visual Impairment, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9921288
Dermatitis, Erythema, Oedema, Tenderness
This Dermatitis side effect was reported by a health professional from US. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: metastatic neoplasm,sarcoma.The patient was prescribed Gemcitabine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gemcitabine the consumer reported adverse symptoms, such as: Dermatitis, Erythema, Oedema, TendernessThese side effects may potentially be related to Gemcitabine. The patient was hospitalized.
Gemcitabine Side Effect Report#9915915
Fall, Dizziness, Dyspnoea, Subdural Haemorrhage, Platelet Count Decreased, Pleural Effusion, Atelectasis, Pericardial Effusion, Ascites
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Gemcitabine Hydrochloride (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Fall, Dizziness, Dyspnoea, Subdural Haemorrhage, Platelet Count Decreased, Pleural Effusion, Atelectasis, Pericardial Effusion, Ascites after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine Hydrochloride treatment in female patients, resulting in Fall side effect. The patient was hospitalized.
Gemcitabine Side Effect Report#9915673
Posterior Reversible Encephalopathy Syndrome
This report suggests a potential Gemcitabine Hydrochloride Posterior Reversible Encephalopathy Syndrome side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: lung adenocarcinoma and used Gemcitabine Hydrochloride (dosage: NA) starting NS. After starting Gemcitabine Hydrochloride the patient began experiencing various side effects, including: Posterior Reversible Encephalopathy SyndromeAdditional drugs used concurrently:
  • Bevacizumab
  • Cisplatin
The patient was hospitalized. Although Gemcitabine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Posterior Reversible Encephalopathy Syndrome, may still occur.
Gemcitabine Side Effect Report#9915581
Cellulitis
This Cellulitis problem was reported by a health professional from Country Not Specified. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Gemcitabine (dosage: NA). The following drugs were being taken at the same time: NA. When using Gemcitabine, the patient experienced the following unwanted symptoms/side effects: CellulitisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cellulitis, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9913585
Fall, Balance Disorder, Dizziness, Head Injury, Dyspnoea, Blood Potassium Decreased, Granulocyte Count Decreased, Platelet Count Decreased, Pleural Effusion
This Fall side effect was reported by a physician from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gemcitabine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gemcitabine Hydrochloride the consumer reported adverse symptoms, such as: Fall, Balance Disorder, Dizziness, Head Injury, Dyspnoea, Blood Potassium Decreased, Granulocyte Count Decreased, Platelet Count Decreased, Pleural EffusionThese side effects may potentially be related to Gemcitabine Hydrochloride. The patient was hospitalized.
Gemcitabine Side Effect Report#9913529
Asthenia, Diarrhoea, Urine Output Increased, Syncope, Haemoglobin Decreased, Occult Blood Positive
This is a report of a 73-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Gemcitabine Hydrochloride (dosage: NA, start time:
Dec 04, 2013), combined with: NA. and developed a serious reaction and side effect(s): Asthenia, Diarrhoea, Urine Output Increased, Syncope, Haemoglobin Decreased, Occult Blood Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine Hydrochloride treatment in male patients, resulting in Asthenia side effect.
Gemcitabine Side Effect Report#9912992
Pulmonary Fibrosis, Hyperthermia, Hyperhidrosis, Tremor, Interstitial Lung Disease
This report suggests a potential Gemcitabine Pulmonary Fibrosis side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: ductal adenocarcinoma of pancreas and used Gemcitabine (dosage: 2000 Mg According To Course, (one Course A Week, 3 Weeks Every 4 Weeks) starting
Aug 08, 2013. After starting Gemcitabine the patient began experiencing various side effects, including: Pulmonary Fibrosis, Hyperthermia, Hyperhidrosis, Tremor, Interstitial Lung DiseaseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Gemcitabine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Fibrosis, may still occur.
Gemcitabine Side Effect Report#9910937
Pericarditis
This Pericarditis problem was reported by a consumer or non-health professional from FR. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ovarian epithelial cancer. On
Jun 04, 2013 this consumer started treatment with Gemcitabine Actavis (dosage: 1000 Mg/m2, Daily). The following drugs were being taken at the same time: NA. When using Gemcitabine Actavis, the patient experienced the following unwanted symptoms/side effects: PericarditisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pericarditis, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9909127
Haemolytic Uraemic Syndrome, Thrombotic Thrombocytopenic Purpura
This Haemolytic Uraemic Syndrome side effect was reported by a health professional from KR. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma metastatic.The patient was prescribed Gemcitabine Hydrochloride (drug dosage: 2700 Mg By A 30-min Infusion), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gemcitabine Hydrochloride the consumer reported adverse symptoms, such as: Haemolytic Uraemic Syndrome, Thrombotic Thrombocytopenic PurpuraThese side effects may potentially be related to Gemcitabine Hydrochloride. The patient was hospitalized.
Gemcitabine Side Effect Report#9909105
Haemolytic Uraemic Syndrome, Thrombotic Microangiopathy
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pancreatic carcinoma metastatic, who was treated with Gemcitabine Hydrochloride (dosage: 800 Mg/m2, Weekly For Three Consecutive Weeks With 1 Week Of Rest, Repeated Every 4 Weeks, start time: 199001), combined with: NA. and developed a serious reaction and side effect(s): Haemolytic Uraemic Syndrome, Thrombotic Microangiopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine Hydrochloride treatment in male patients, resulting in Haemolytic Uraemic Syndrome side effect. The patient was hospitalized.
Gemcitabine Side Effect Report#9909083
Thrombotic Microangiopathy
This report suggests a potential Gemcitabine Hydrochloride Thrombotic Microangiopathy side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hodgkin^s disease and used Gemcitabine Hydrochloride (dosage: 2 Out Of Every 3 Weeks) starting NS. After starting Gemcitabine Hydrochloride the patient began experiencing various side effects, including: Thrombotic MicroangiopathyAdditional drugs used concurrently:
  • Vinorelbine (Unk)
  • Doxorubicin Hydrochloride (Unk)
Although Gemcitabine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thrombotic Microangiopathy, may still occur.
Gemcitabine Side Effect Report#9907987
Thrombotic Microangiopathy
This Thrombotic Microangiopathy problem was reported by a physician from AU. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: adenocarcinoma pancreas. On 201103 this consumer started treatment with Gemcitabine (dosage: Total Dose- 31860 Mg). The following drugs were being taken at the same time:
  • Atenolol
  • Frusemide
  • Meloxicam
  • Digoxin
  • Aspirin
  • Pancreatic Enzymes
When using Gemcitabine, the patient experienced the following unwanted symptoms/side effects: Thrombotic MicroangiopathyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombotic Microangiopathy, may become evident only after a product is in use by the general population.
Gemcitabine Side Effect Report#9907976
Thrombotic Microangiopathy
This Thrombotic Microangiopathy side effect was reported by a physician from AU. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: adenocarcinoma pancreas.The patient was prescribed Gemcitabine (drug dosage: 1000 Mg/m2, On Days 1, 8, And 15 In A 28-day Cycle), which was initiated on
Jul 12, 2011. Concurrently used drugs: NA..After starting to take Gemcitabine the consumer reported adverse symptoms, such as: Thrombotic MicroangiopathyThese side effects may potentially be related to Gemcitabine.
Gemcitabine Side Effect Report#9904669
Thrombotic Microangiopathy
This is a report of a 58-year-old female patient (weight: NA) from AT, suffering from the following health symptoms/conditions: cholangiocarcinoma, who was treated with Gemcitabine Hydrochloride (dosage: 1.6 G (1000 Mg/m2) Cyclic, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Thrombotic Microangiopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gemcitabine Hydrochloride treatment in female patients, resulting in Thrombotic Microangiopathy side effect. The patient was hospitalized.


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The appearance of Gemcitabine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Gemcitabine Side Effects for Women?

Women Side EffectsReports
Nausea 109
Anaemia 96
Dyspnoea 94
Neutropenia 85
Vomiting 84
Pyrexia 83
Thrombocytopenia 83
Pneumonia 75
Dehydration 70
Asthenia 69

What are common Gemcitabine Side Effects for Men?

Men Side EffectsReports
Nausea 113
Pneumonia 102
Anaemia 96
Dyspnoea 93
Vomiting 93
Pyrexia 89
Thrombocytopenia 87
Dehydration 76
Diarrhoea 72
Fatigue 62

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Gemcitabine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Gemcitabine Side Effects

    Did You Have a Gemcitabine Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Gemcitabine for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Gemcitabine Safety Alerts, Active Ingredients, Usage Information

    NDC0069-3857
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameGemcitabine Hydrochloride
    NameGemcitabine Hydrochloride
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteINTRAVENOUS
    On market since20110725
    LabelerPfizer Laboratories Div Pfizer Inc.
    Active Ingredient(s)GEMCITABINE HYDROCHLORIDE
    Strength(s)200
    Unit(s)mg/5mL
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

    More About Gemcitabine

    Side Effects reported to FDA: 3045

    Gemcitabine safety alerts: No

    Reported deaths: 223

    Reported hospitalizations: 746

    Latest Gemcitabine clinical trials