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Fluorouracil Side Effects

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Common Fluorouracil Side Effects


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

Diarrhoea (462)
Nausea (335)
Dehydration (273)
Vomiting (266)
Neutropenia (243)
Febrile Neutropenia (207)
Pyrexia (187)
Mucosal Inflammation (179)
Asthenia (158)
Abdominal Pain (151)
Stomatitis (143)
Fatigue (134)
Dyspnoea (131)
Interstitial Lung Disease (117)
Decreased Appetite (116)
Pulmonary Embolism (111)
Chest Pain (109)
Anaemia (106)
Thrombocytopenia (106)
Hypotension (106)

➢ 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.

Fluorouracil Side Effects Reported to FDA



Fluorouracil Side Effect Report#9999067
Agitation, Confusional State, Disorientation, Thrombocytopenia
This is a report of a 68-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: squamous cell carcinoma of the oral cavity, who was treated with Fluorouracil (dosage: NA, start time:
Jan 21, 2014), combined with:
  • Carboplatin
  • Erbitux
  • Lovenox
  • Lovenox
  • Valproate Sodium
  • Esomeprazole Magnesium
  • Kardegic
  • Durogesic
and developed a serious reaction and side effect(s): Agitation, Confusional State, Disorientation, Thrombocytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in male patients, resulting in Agitation side effect. The patient was hospitalized.
Fluorouracil Side Effect Report#9999066
Neutropenia, Mucosal Inflammation, Alopecia
This report suggests a potential Fluorouracil Neutropenia side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: adenocarcinoma of colon and used Fluorouracil (dosage: NA) starting NS. After starting Fluorouracil the patient began experiencing various side effects, including: Neutropenia, Mucosal Inflammation, AlopeciaAdditional drugs used concurrently: NA. Although Fluorouracil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenia, may still occur.
Fluorouracil Side Effect Report#9995206
Neutropenia, Diarrhoea, Nausea, Decreased Appetite
This Neutropenia problem was reported by a health professional from JP. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: gingival cancer. On NS this consumer started treatment with Fluorouracil (dosage: NA). The following drugs were being taken at the same time:
  • Docetaxel
  • Cisplatin
When using Fluorouracil, the patient experienced the following unwanted symptoms/side effects: Neutropenia, Diarrhoea, Nausea, Decreased AppetiteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutropenia, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9995195
Stress Cardiomyopathy, Cardiogenic Shock, Intracardiac Thrombus, Fatigue, Decreased Appetite, Nausea, Vomiting, Malaise, Hypophagia
This Stress Cardiomyopathy side effect was reported by a consumer or non-health professional from AU. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: rectal adenocarcinoma.The patient was prescribed Fluorouracil (fluorouracil) (fluorouracil) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Leucovorin (folinic Acid) (folinic Acid)
.After starting to take Fluorouracil (fluorouracil) (fluorouracil) the consumer reported adverse symptoms, such as: Stress Cardiomyopathy, Cardiogenic Shock, Intracardiac Thrombus, Fatigue, Decreased Appetite, Nausea, Vomiting, Malaise, HypophagiaThese side effects may potentially be related to Fluorouracil (fluorouracil) (fluorouracil). The patient was hospitalized.
Fluorouracil Side Effect Report#9995160
Electrolyte Imbalance, Neutrophil Count Decreased, Decreased Appetite, Dermatitis Acneiform, Hypoaesthesia, Off Label Use
This is a report of a 75-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: adenocarcinoma, who was treated with Fluorouracil (dosage: NA, start time: 201204), combined with:
  • Cisplatin (cisplatin) (cisplatin)
  • Cetuximab (cetuximab) (cetuximab)
  • Docetaxel (docetaxel) (docetaxel)
  • Carboplatin
and developed a serious reaction and side effect(s): Electrolyte Imbalance, Neutrophil Count Decreased, Decreased Appetite, Dermatitis Acneiform, Hypoaesthesia, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in male patients, resulting in Electrolyte Imbalance side effect.
Fluorouracil Side Effect Report#9989209
Vomiting, Stomatitis, Pyrexia, Neutropenia, Palmar-plantar Erythrodysaesthesia Syndrome, Asthenia
This report suggests a potential Fluorouracile Teva Vomiting side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: adenocarcinoma of colon and used Fluorouracile Teva (dosage: 1200 Mg/m2 Daily; Concentrate For Solution For Intravenous Infusion) starting
Dec 02, 2013. After starting Fluorouracile Teva the patient began experiencing various side effects, including: Vomiting, Stomatitis, Pyrexia, Neutropenia, Palmar-plantar Erythrodysaesthesia Syndrome, AstheniaAdditional drugs used concurrently:
  • Oxaliplatino Octavis Italy (85 Mg/m2 Daily; Concentrate For Solution For Intravenous Infusion)
  • Calcio Levofolinato Teva (100 Mg/kg Daily; Powder For Solution For Intravenous Infusion)
Although Fluorouracile Teva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vomiting, may still occur.
Fluorouracil Side Effect Report#9988753
Hepatic Steatosis, Disease Progression
This Hepatic Steatosis problem was reported by a physician from DK. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 29, 2013 this consumer started treatment with Fluorouracil (dosage: Cmf Treatment Regimen). The following drugs were being taken at the same time:
  • Gemcitabine/gemcitabine Hydrochloride
  • Taxol
  • Cyclophosphamide/cyclophosphamide Monohydrate (Cmf Treatment Regimen)
  • Navelbine
  • Methotrexate (Cmf Treatment Regimen)
  • Herceptin (In Combination With Eribulin From 29-aug-2013)
  • Xeloda
  • Eribulin
When using Fluorouracil, the patient experienced the following unwanted symptoms/side effects: Hepatic Steatosis, Disease ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Steatosis, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9981207
Cardiac Failure, Ascites, Dyspnoea, Leukocytosis
This Cardiac Failure side effect was reported by a health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma.The patient was prescribed Fluorouracil (drug dosage: NA), which was initiated on
Dec 23, 2013. Concurrently used drugs: NA..After starting to take Fluorouracil the consumer reported adverse symptoms, such as: Cardiac Failure, Ascites, Dyspnoea, LeukocytosisThese side effects may potentially be related to Fluorouracil. The patient was hospitalized.
Fluorouracil Side Effect Report#9973725
Extravasation, Oedema, Skin Necrosis
This is a report of a 50-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Fluorouracile Teva (dosage: NA, start time:
Jan 18, 2010), combined with: NA. and developed a serious reaction and side effect(s): Extravasation, Oedema, Skin Necrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracile Teva treatment in female patients, resulting in Extravasation side effect.
Fluorouracil Side Effect Report#9970153
Neutropenia, Off Label Use, Thrombocytopenia
This report suggests a potential Fluorouracil (fluorouracil) Neutropenia side effect(s) that can have serious consequences. A 15-year-old male patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: metastases to lung,pancreatic carcinoma and used Fluorouracil (fluorouracil) (dosage: NA) starting 201105. After starting Fluorouracil (fluorouracil) the patient began experiencing various side effects, including: Neutropenia, Off Label Use, ThrombocytopeniaAdditional drugs used concurrently: NA. Although Fluorouracil (fluorouracil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenia, may still occur.
Fluorouracil Side Effect Report#9966958
Hepatic Failure, Acute Hepatitis B
This Hepatic Failure problem was reported by a physician from JP. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On NS this consumer started treatment with Fluorouracil (dosage: 500 Mg/m2, Unk). The following drugs were being taken at the same time:
  • Doxorubicin (50 Mg/m2, Unk)
  • Cyclophosphamide Monohydrate (500 Mg/m2, Unk)
When using Fluorouracil, the patient experienced the following unwanted symptoms/side effects: Hepatic Failure, Acute Hepatitis BThe 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 Hepatic Failure, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9964529
Renal Failure Acute, Hyperkalaemia
This Renal Failure Acute side effect was reported by a health professional from FR. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: rectal adenocarcinoma.The patient was prescribed Fluorouracile Teva (drug dosage: NA), which was initiated on
Jul 16, 2013. Concurrently used drugs: NA..After starting to take Fluorouracile Teva the consumer reported adverse symptoms, such as: Renal Failure Acute, HyperkalaemiaThese side effects may potentially be related to Fluorouracile Teva.
Fluorouracil Side Effect Report#9961367
Diarrhoea, Nausea, Ileus, Abdominal Distension
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: neoplasm malignant, who was treated with Fluorouracil (dosage: NA, start time:
May 04, 2010), combined with: NA. and developed a serious reaction and side effect(s): Diarrhoea, Nausea, Ileus, Abdominal Distension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in male patients, resulting in Diarrhoea side effect. The patient was hospitalized.
Fluorouracil Side Effect Report#9958592
Hyperhidrosis, Laryngospasm, Off Label Use, Dyslalia
This report suggests a potential Fluorouracil Hyperhidrosis side effect(s) that can have serious consequences. A 42-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Fluorouracil (dosage: NA) starting NS. After starting Fluorouracil the patient began experiencing various side effects, including: Hyperhidrosis, Laryngospasm, Off Label Use, DyslaliaAdditional drugs used concurrently:
  • Oxaliplatin
  • Irinotecan
Although Fluorouracil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperhidrosis, may still occur.
Fluorouracil Side Effect Report#9958539
Vomiting, Nausea, Dyspepsia
This Vomiting problem was reported by a consumer or non-health professional from US. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: adenocarcinoma of colon. On
Jan 29, 2014 this consumer started treatment with Fluorouracil (dosage: NA). The following drugs were being taken at the same time: NA. When using Fluorouracil, the patient experienced the following unwanted symptoms/side effects: Vomiting, Nausea, DyspepsiaThe 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 Vomiting, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9948874
Pulmonary Arterial Hypertension, Cardiac Failure, Skin Ulcer, Ejection Fraction Decreased
This Pulmonary Arterial Hypertension side effect was reported by a health professional from FR. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: colon cancer metastatic.The patient was prescribed Fluorouracil (drug dosage: 34 Courses (from J1 To J15)), which was initiated on
Aug 01, 2012. Concurrently used drugs:
  • Irinotecan (34 Courses (from J1 To J15))
  • Ondansetron
  • Urorec
  • Permixon
  • Eucreas (50 Mg/1000 Mg)
  • Methylprednisolone
  • Atropine
  • Aprepitant
.After starting to take Fluorouracil the consumer reported adverse symptoms, such as: Pulmonary Arterial Hypertension, Cardiac Failure, Skin Ulcer, Ejection Fraction DecreasedThese side effects may potentially be related to Fluorouracil. The patient was hospitalized.
Fluorouracil Side Effect Report#9937240
Febrile Neutropenia, Neutropenic Sepsis, Malaise, Tremor
This is a report of a 40-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: breast cancer, who was treated with Fluorouracil (dosage: NA, start time:
Nov 20, 2013), combined with:
  • Epirubicin
  • Cyclophosphamide
  • Neulasta
and developed a serious reaction and side effect(s): Febrile Neutropenia, Neutropenic Sepsis, Malaise, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in female patients, resulting in Febrile Neutropenia side effect. The patient was hospitalized.
Fluorouracil Side Effect Report#9931508
Necrotising Fasciitis, Off Label Use
This report suggests a potential Fluorouracil Necrotising Fasciitis side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from NG was diagnosed with the following symptoms/conditions: pancreatic carcinoma and used Fluorouracil (dosage: NA) starting NS. After starting Fluorouracil the patient began experiencing various side effects, including: Necrotising Fasciitis, Off Label UseAdditional drugs used concurrently:
  • Cisplatin
  • Doxorubicin
Although Fluorouracil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Necrotising Fasciitis, may still occur.
Fluorouracil Side Effect Report#9931502
Leukoencephalopathy, Dysarthria, Hemiparesis, Somnolence, Gaze Palsy, Altered State Of Consciousness
This Leukoencephalopathy problem was reported by a health professional from JP. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: oesophageal carcinoma. On NS this consumer started treatment with Fluorouracil (dosage: NA). The following drugs were being taken at the same time:
  • Nedaplatin (nedaplatin) (nedaplatin)
When using Fluorouracil, the patient experienced the following unwanted symptoms/side effects: Leukoencephalopathy, Dysarthria, Hemiparesis, Somnolence, Gaze Palsy, Altered State Of ConsciousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Leukoencephalopathy, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9931354
Neutropenia, Lymphopenia
This Neutropenia side effect was reported by a physician from PL. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Fluorouracil (drug dosage: NA), which was initiated on
Jan 08, 2014. Concurrently used drugs:
  • Doxorubicin (Adriamycin)
  • Cyclophosphamide/cyclophosphamide Monohydrate
.After starting to take Fluorouracil the consumer reported adverse symptoms, such as: Neutropenia, LymphopeniaThese side effects may potentially be related to Fluorouracil.
Fluorouracil Side Effect Report#9931346
Tremor, Neutropenic Sepsis
This is a report of a 40-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: breast cancer, who was treated with Fluorouracil (dosage: Unk, start time:
Nov 20, 2013), combined with:
  • Epirubicin (Unk)
  • Cyclophosphamide/cyclophosphamide Monohydrate (Unk)
  • Neulasta (Unk, 3/52)
and developed a serious reaction and side effect(s): Tremor, Neutropenic Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in female patients, resulting in Tremor side effect. The patient was hospitalized.
Fluorouracil Side Effect Report#9929261
Hypersensitivity Vasculitis, Renal Failure Chronic, Iga Nephropathy, Glomerulosclerosis, Toxicity To Various Agents, Metastases To Lung, Metastases To Liver, Haemodialysis
This report suggests a potential Fluorouracil (fluorouracil) (solution For Infusion) (fluorouracil) Hypersensitivity Vasculitis side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: colon cancer,metastases to lung and used Fluorouracil (fluorouracil) (solution For Infusion) (fluorouracil) (dosage: 2400 Mg/m2, Every Cycle, Intravenous (not Otherwise Specified)) starting NS. After starting Fluorouracil (fluorouracil) (solution For Infusion) (fluorouracil) the patient began experiencing various side effects, including: Hypersensitivity Vasculitis, Renal Failure Chronic, Iga Nephropathy, Glomerulosclerosis, Toxicity To Various Agents, Metastases To Lung, Metastases To Liver, HaemodialysisAdditional drugs used concurrently: NA. Although Fluorouracil (fluorouracil) (solution For Infusion) (fluorouracil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity Vasculitis, may still occur.
Fluorouracil Side Effect Report#9929251
Angina Pectoris, Ventricular Tachycardia
This Angina Pectoris problem was reported by a health professional from DE. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypopharyngeal cancer. On NS this consumer started treatment with Fluorouracil (fluorouracil) (infusion) (fluorouracil) (dosage: NA). The following drugs were being taken at the same time:
  • Carboplatin
When using Fluorouracil (fluorouracil) (infusion) (fluorouracil), the patient experienced the following unwanted symptoms/side effects: Angina Pectoris, Ventricular TachycardiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Angina Pectoris, may become evident only after a product is in use by the general population.
Fluorouracil Side Effect Report#9929250
Angina Pectoris
This Angina Pectoris side effect was reported by a physician from DE. A 62-year-old male patient (weight:NA) experienced the following symptoms/conditions: squamous cell carcinoma.The patient was prescribed Fluorouracil (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fluorouracil the consumer reported adverse symptoms, such as: Angina PectorisThese side effects may potentially be related to Fluorouracil.
Fluorouracil Side Effect Report#9929101
Venoocclusive Liver Disease
This is a report of a 46-year-old patient (weight: NA) from DE, suffering from the following health symptoms/conditions: colon cancer, who was treated with Fluorouracil (dosage: NA, start time: NS), combined with:
  • Leucovorin Calcium
and developed a serious reaction and side effect(s): Venoocclusive Liver Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluorouracil treatment in patients, resulting in Venoocclusive Liver Disease side effect.


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The appearance of Fluorouracil 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 Fluorouracil Side Effects for Women?

Women Side EffectsReports
Diarrhoea 220
Nausea 184
Vomiting 143
Dehydration 132
Neutropenia 123
Febrile Neutropenia 95
Mucosal Inflammation 89
Asthenia 86
Abdominal Pain 78
Pyrexia 77

What are common Fluorouracil Side Effects for Men?

Men Side EffectsReports
Diarrhoea 234
Nausea 150
Dehydration 134
Vomiting 123
Neutropenia 115
Pyrexia 108
Febrile Neutropenia 105
Interstitial Lung Disease 87
Mucosal Inflammation 85
Stomatitis 84

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.

    Fluorouracil 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 Fluorouracil Side Effects

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    How Effective is Fluorouracil for You?

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    Fluorouracil Safety Alerts, Active Ingredients, Usage Information

    NDC0069-0169
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFluorouracil
    NameFluorouracil
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVENOUS
    On market since20120718
    LabelerPfizer Laboratories Div Pfizer Inc.
    Active Ingredient(s)FLUOROURACIL
    Strength(s)50
    Unit(s)mg/mL
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

    More About Fluorouracil

    Side Effects reported to FDA: 4125

    Fluorouracil safety alerts: 2005

    Reported deaths: 637

    Reported hospitalizations: 2264

    Fluorouracil Injection 50mg/mL, (500 mg/10mL Single Dose Vial)

    Audience: Oncologists, pharmacists, and other healthcare professionals

    [Posted 09/27/2005] American Pharmaceutical Partners, Inc. and FDA notified healthcare professionals about a nationwide recall of Fluorouracil Injection 50 mg/mL (500 mg/10ml Single Dose Vial) because of the potential for invisible glass particles containing silica and aluminum in vials of the product. The company states that only Product code 101710 is susceptible to this type of glass breakdown.

    [September 2005 - Product Recall - American Pharmaceutical Partners, Inc.]
    [September 2005 - Dear Healthcare Professional Letter - American Pharmaceutical Partners, Inc.]

    Latest Fluorouracil clinical trials