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Irinotecan Side Effects

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Common Irinotecan Side Effects


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

Diarrhoea (323)
Vomiting (150)
Neutropenia (133)
Nausea (127)
Interstitial Lung Disease (120)
Dehydration (100)
Pyrexia (89)
Asthenia (85)
Leukopenia (81)
Abdominal Pain (77)
Death (71)
Sepsis (71)
Thrombocytopenia (70)
Febrile Neutropenia (69)
Dyspnoea (66)
Neuropathy Peripheral (60)
Disease Progression (59)
Anaemia (57)
Fatigue (57)
Pulmonary Embolism (55)

➢ 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.

Irinotecan Side Effects Reported to FDA



Irinotecan Side Effect Report#9998929
Pneumocystis Jirovecii Infection, Lymphopenia, Dyspnoea
This is a report of a 63-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: palliative care, who was treated with Irinotecan Hydrochloride (dosage: NA, start time:
Oct 31, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumocystis Jirovecii Infection, Lymphopenia, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan Hydrochloride treatment in male patients, resulting in Pneumocystis Jirovecii Infection side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9991574
Immune Thrombocytopenic Purpura
This report suggests a potential Irinotecan Hcl Immune Thrombocytopenic Purpura side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colon cancer metastatic and used Irinotecan Hcl (dosage: 6 Two-week Cycles) starting NS. After starting Irinotecan Hcl the patient began experiencing various side effects, including: Immune Thrombocytopenic PurpuraAdditional drugs used concurrently: NA. Although Irinotecan Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Immune Thrombocytopenic Purpura, may still occur.
Irinotecan Side Effect Report#9988869
Nausea, Diarrhoea, Thrombocytopenia, Infusion Related Reaction, Erythropenia, Anaemia, Hyposideraemia, Influenza, Tonsillitis
This Nausea problem was reported by a physician from IT. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rectal adenocarcinoma. On
Jul 20, 2012 this consumer started treatment with Irinotecan (dosage: 307 Mg In 1st Cycle, 230 Mg In Next Cycles.). The following drugs were being taken at the same time:
  • Fluorouracil (4789 Mg 1st Cycle,3500 Mg In Next Cycles)
  • Avastin
  • Eloxatin
  • Erbitux (1st Cycle;640 Mg In 2nd And 3rd Cycle;635 Mg 5th Cycle.)
  • Emend
  • Calcium Levofolinate
  • Perfalgan
  • Eutirox (^25 Mg Tablets^ 50 Tablets)
When using Irinotecan, the patient experienced the following unwanted symptoms/side effects: Nausea, Diarrhoea, Thrombocytopenia, Infusion Related Reaction, Erythropenia, Anaemia, Hyposideraemia, Influenza, TonsillitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9988308
Pneumocystis Jirovecii Infection, Lymphopenia, Dyspnoea
This Pneumocystis Jirovecii Infection side effect was reported by a health professional from GB. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: palliative care.The patient was prescribed Irinotecan (drug dosage: 180 Mg/m2), which was initiated on
Oct 31, 2013. Concurrently used drugs: NA..After starting to take Irinotecan the consumer reported adverse symptoms, such as: Pneumocystis Jirovecii Infection, Lymphopenia, DyspnoeaThese side effects may potentially be related to Irinotecan. The patient was hospitalized.
Irinotecan Side Effect Report#9976027
Pneumocystis Jirovecii Infection, Dyspnoea, Lymphopenia
This is a report of a 63-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: palliative care, who was treated with Irinotecan Hydrochloride (dosage: NA, start time:
Oct 31, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumocystis Jirovecii Infection, Dyspnoea, Lymphopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan Hydrochloride treatment in male patients, resulting in Pneumocystis Jirovecii Infection side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9972439
Tuberculous Pleurisy, Metastases To Central Nervous System
This report suggests a potential Irinotecan Hci Tuberculous Pleurisy side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: NA and used Irinotecan Hci (dosage: NA) starting NS. After starting Irinotecan Hci the patient began experiencing various side effects, including: Tuberculous Pleurisy, Metastases To Central Nervous SystemAdditional drugs used concurrently:
  • Cisplatin Inj. 50mg/50ml -bedford Labs, Inc
Although Irinotecan Hci demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tuberculous Pleurisy, may still occur.
Irinotecan Side Effect Report#9972121
Urticaria, Dysphagia, Infusion Related Reaction
This Urticaria problem was reported by a health professional from FR. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: rectal cancer. On
Jan 21, 2014 this consumer started treatment with Irinotecan (dosage: NA). The following drugs were being taken at the same time:
  • Elvorine
  • Aprepitant
  • Dexamethasone
  • Ondansetron
  • Oxaliplatin
  • Atropine
When using Irinotecan, the patient experienced the following unwanted symptoms/side effects: Urticaria, Dysphagia, Infusion Related ReactionThe 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 Urticaria, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9972106
Ejection Fraction Decreased, Pulmonary Arterial Hypertension, Oedema Peripheral, Ulcer, Disease Progression, Ascites, Pleural Effusion
This Ejection Fraction Decreased 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 Irinotecan (drug dosage: NA), which was initiated on
Aug 01, 2012. Concurrently used drugs:
  • Avastin (bevacizumab) (bevacizumab)
  • Fluorouracil Accord
  • Amlodipine
  • Glimepiride
  • Permixon (serenoa Repens Extract)
  • Urorec (silodosin)
  • Eucreas
.After starting to take Irinotecan the consumer reported adverse symptoms, such as: Ejection Fraction Decreased, Pulmonary Arterial Hypertension, Oedema Peripheral, Ulcer, Disease Progression, Ascites, Pleural EffusionThese side effects may potentially be related to Irinotecan. The patient was hospitalized.
Irinotecan Side Effect Report#9972077
Asthenia, Vomiting, Diarrhoea, Dehydration, Hypomagnesaemia, Hypokalaemia, Fall
This is a report of a 77-year-old patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Irinotecan (dosage: NA, start time:
Dec 20, 2013), combined with:
  • Xeloda (capecitabine) (capecitabine)
and developed a serious reaction and side effect(s): Asthenia, Vomiting, Diarrhoea, Dehydration, Hypomagnesaemia, Hypokalaemia, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan treatment in patients, resulting in Asthenia side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9959302
Neutropenic Sepsis, Haemoglobin Increased, Febrile Neutropenia
This report suggests a potential Irinotecan Hydrochloride Neutropenic Sepsis side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Irinotecan Hydrochloride (dosage: Intraveanous (not Otherwise Specified)) starting
Oct 03, 2013. After starting Irinotecan Hydrochloride the patient began experiencing various side effects, including: Neutropenic Sepsis, Haemoglobin Increased, Febrile NeutropeniaAdditional drugs used concurrently:
  • Pegfilgrastim (2/52, Intravenous (not Otherwise Specified))
  • Flurouracil
  • Folinicacid
The patient was hospitalized. Although Irinotecan Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenic Sepsis, may still occur.
Irinotecan Side Effect Report#9927850
Hypercreatinaemia
This Hypercreatinaemia problem was reported by a health professional from IT. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colon cancer metastatic. On
May 14, 2013 this consumer started treatment with Irinotecan Hydrochloride (dosage: Cyclical). The following drugs were being taken at the same time:
  • Fluorouracil (Cyclical)
  • Lederfolin
When using Irinotecan Hydrochloride, the patient experienced the following unwanted symptoms/side effects: HypercreatinaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypercreatinaemia, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9926181
Neutropenic Sepsis, Febrile Neutropenia, Malaise, Body Temperature Increased
This Neutropenic Sepsis side effect was reported by a health professional from GB. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Irinotecan (drug dosage: Unk), which was initiated on
Oct 03, 2013. Concurrently used drugs:
  • Neulasta (Unk 2/52)
  • Fluorouracil (Unk)
  • Folinic Acid (Unk)
.After starting to take Irinotecan the consumer reported adverse symptoms, such as: Neutropenic Sepsis, Febrile Neutropenia, Malaise, Body Temperature IncreasedThese side effects may potentially be related to Irinotecan. The patient was hospitalized.
Irinotecan Side Effect Report#9925372
Pneumocystis Jirovecii Infection, Lymphopenia, Dyspnoea
This is a report of a 63-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: palliative care, who was treated with Irinotecan Hcl (dosage: 180 Mg/m2, Unk, start time:
Oct 31, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumocystis Jirovecii Infection, Lymphopenia, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan Hcl treatment in male patients, resulting in Pneumocystis Jirovecii Infection side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9920220
Post Embolisation Syndrome, Nausea, Vomiting, Pain, Pyrexia, Hepatic Enzyme Increased, Diarrhoea
This report suggests a potential Irinotecan Post Embolisation Syndrome side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: colorectal cancer metastatic and used Irinotecan (dosage: 100 Mg, Unk) starting 201304. After starting Irinotecan the patient began experiencing various side effects, including: Post Embolisation Syndrome, Nausea, Vomiting, Pain, Pyrexia, Hepatic Enzyme Increased, DiarrhoeaAdditional drugs used concurrently: NA. Although Irinotecan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Post Embolisation Syndrome, may still occur.
Irinotecan Side Effect Report#9916056
Hypercreatinaemia
This Hypercreatinaemia problem was reported by a physician from IT. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colon cancer metastatic. On
May 14, 2013 this consumer started treatment with Irinotecan Hydrochloride Trihydrate (dosage: 200 Mg Cyclical). The following drugs were being taken at the same time:
  • Fluorouracil (2160 Mg Cyclical)
  • Lederfolin
When using Irinotecan Hydrochloride Trihydrate, the patient experienced the following unwanted symptoms/side effects: HypercreatinaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypercreatinaemia, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9913548
Subcutaneous Abscess
This Subcutaneous Abscess side effect was reported by a health professional from IT. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma.The patient was prescribed Irinotecan (drug dosage: NA), which was initiated on
Sep 18, 2013. Concurrently used drugs:
  • Oxaliplatin (Body Surface)
  • Fluorouracil (Body Surface)
.After starting to take Irinotecan the consumer reported adverse symptoms, such as: Subcutaneous AbscessThese side effects may potentially be related to Irinotecan. The patient was hospitalized.
Irinotecan Side Effect Report#9913170
Tremor, Asthenia, Diarrhoea
This is a report of a 70-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: pancreatic carcinoma, who was treated with Irinotecan (dosage: 240, Mg/mq Body Surface, start time:
Jan 21, 2013), combined with:
  • Oxaliplatin Accord (Cyclical)
  • Fluorouracil (3200, Mg/mq Body Surface)
and developed a serious reaction and side effect(s): Tremor, Asthenia, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan treatment in female patients, resulting in Tremor side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9913159
Tuberculous Pleurisy, Metastases To Central Nervous System, Small Cell Lung Cancer Extensive Stage, Malignant Neoplasm Progression
This report suggests a potential Irinotecan Tuberculous Pleurisy side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: small cell lung cancer extensive stage and used Irinotecan (dosage: On Day 1 And 8 Of A 3-weekly Cycle) starting NS. After starting Irinotecan the patient began experiencing various side effects, including: Tuberculous Pleurisy, Metastases To Central Nervous System, Small Cell Lung Cancer Extensive Stage, Malignant Neoplasm ProgressionAdditional drugs used concurrently:
  • Cisplatin (On Day 1 And 8 Of A 3-weekly Cycle)
Although Irinotecan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tuberculous Pleurisy, may still occur.
Irinotecan Side Effect Report#9912840
Tuberculosis, Metastases To Pelvis, Metastases To Central Nervous System, Lung Neoplasm Malignant, Malignant Neoplasm Progression
This Tuberculosis problem was reported by a health professional from IN. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: small cell lung cancer. On NS this consumer started treatment with Irinotecan (dosage: NA). The following drugs were being taken at the same time:
  • Cisplatin
When using Irinotecan, the patient experienced the following unwanted symptoms/side effects: Tuberculosis, Metastases To Pelvis, Metastases To Central Nervous System, Lung Neoplasm Malignant, Malignant Neoplasm ProgressionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tuberculosis, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9906764
Neutropenic Sepsis, Febrile Neutropenia, Malaise, Body Temperature Increased
This Neutropenic Sepsis side effect was reported by a health professional from GB. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Irinotecan Hcl (drug dosage: Unk), which was initiated on
Oct 03, 2013. Concurrently used drugs:
  • Neulasta (2/52)
  • Fluorouracil (Unk)
  • Folinic Acid (Unk)
.After starting to take Irinotecan Hcl the consumer reported adverse symptoms, such as: Neutropenic Sepsis, Febrile Neutropenia, Malaise, Body Temperature IncreasedThese side effects may potentially be related to Irinotecan Hcl. The patient was hospitalized.
Irinotecan Side Effect Report#9890488
Bronchospasm, Hypertension, Anaphylactic Reaction, Oxygen Saturation Decreased
This is a report of a 69-year-old male patient (weight: NA) from CZ, suffering from the following health symptoms/conditions: rectal cancer, who was treated with Irinotecan (dosage: 20 Mg/ Ml, start time:
Jan 27, 2014), combined with: NA. and developed a serious reaction and side effect(s): Bronchospasm, Hypertension, Anaphylactic Reaction, Oxygen Saturation Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan treatment in male patients, resulting in Bronchospasm side effect. The patient was hospitalized.
Irinotecan Side Effect Report#9871035
Syncope, Orthostatic Hypotension, Sinus Bradycardia, Dehydration, Pain, Abdominal Tenderness, Abdominal Pain Upper, Syncope, Ileus
This report suggests a potential Irinotecan (cpt-484 Mg 11, Camptosar) Syncope side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Irinotecan (cpt-484 Mg 11, Camptosar) (dosage: NA) starting NS. After starting Irinotecan (cpt-484 Mg 11, Camptosar) the patient began experiencing various side effects, including: Syncope, Orthostatic Hypotension, Sinus Bradycardia, Dehydration, Pain, Abdominal Tenderness, Abdominal Pain Upper, Syncope, IleusAdditional drugs used concurrently: NA.The patient was hospitalized. Although Irinotecan (cpt-484 Mg 11, Camptosar) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Syncope, may still occur.
Irinotecan Side Effect Report#9868559
Tuberculous Pleurisy
This Tuberculous Pleurisy problem was reported by a health professional from IN. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: small cell lung cancer extensive stage. On NS this consumer started treatment with Irinotecan (dosage: 65 Mg/m2 On D1, D8 Of 3w Cycle). The following drugs were being taken at the same time:
  • Cisplatin (30 Mg/m2 On D1, D8 Of 3w Cycle)
When using Irinotecan, the patient experienced the following unwanted symptoms/side effects: Tuberculous PleurisyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tuberculous Pleurisy, may become evident only after a product is in use by the general population.
Irinotecan Side Effect Report#9868545
Atrial Fibrillation
This Atrial Fibrillation side effect was reported by a physician from IT. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Irinotecan Hydrochloride Trihydrate (drug dosage: 320 Mg Cyclical), which was initiated on
Dec 23, 2012. Concurrently used drugs:
  • Fluorouracil (710 Mg Cyclical)
  • Fluorouracil (4320 Ml Cyclical)
  • Erbitux (900 Mg Cyclical)
  • Levofolinic Acid (360 Mg)
.After starting to take Irinotecan Hydrochloride Trihydrate the consumer reported adverse symptoms, such as: Atrial FibrillationThese side effects may potentially be related to Irinotecan Hydrochloride Trihydrate.
Irinotecan Side Effect Report#9866796
Enteritis
This is a report of a 63-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: colon cancer, who was treated with Irinotecan (dosage: 20 Mg/ml, 1 Glass Ampoule 5 Ml, start time:
May 27, 2013), combined with:
  • Fluorouracil (5 G/100 Ml)
  • Erbitux (5 Mg/ml)
  • Fluorouracil
and developed a serious reaction and side effect(s): Enteritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Irinotecan treatment in female patients, resulting in Enteritis side effect.


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The appearance of Irinotecan 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 Irinotecan Side Effects for Women?

Women Side EffectsReports
Diarrhoea 119
Vomiting 75
Nausea 51
Neutropenia 51
Pyrexia 40
Leukopenia 38
Abdominal Pain 36
Dyspnoea 30
Dehydration 29
Asthenia 28

What are common Irinotecan Side Effects for Men?

Men Side EffectsReports
Diarrhoea 197
Interstitial Lung Disease 99
Neutropenia 81
Nausea 72
Dehydration 70
Vomiting 70
Asthenia 53
Sepsis 47
Death 46
Pyrexia 46

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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.

    Irinotecan 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 Irinotecan Side Effects

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    How Effective is Irinotecan for You?

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    Irinotecan Safety Alerts, Active Ingredients, Usage Information

    NDC0143-9701
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameIrinotecan Hydrochloride
    NameIrinotecan Hydrochloride
    Dosage FormINJECTION
    RouteINTRAVENOUS
    On market since20101220
    LabelerWest-Ward Pharmaceutical Corp
    Active Ingredient(s)IRINOTECAN HYDROCHLORIDE
    Strength(s)20
    Unit(s)mg/mL
    Pharma ClassTopoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]

    More About Irinotecan

    Side Effects reported to FDA: 1994

    Irinotecan safety alerts: 2011 2002

    Reported deaths: 441

    Reported hospitalizations: 952

    Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant

    [Posted 03/28/2011]

    AUDIENCE: Oncology, Pharmacy, Risk Manager

    ISSUE: APP Pharmaceuticals, Inc. issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection due to the discovery of foreign material and non-sterility in one lot of Irinotecan injection. Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

    BACKGROUND: Irinotecan Hydrochloride Injection is used for recurrent or progressive metastatic colorectal cancer. Three customers reported that they discovered a particulate in the product solution in lot 870DE00301. Investigation of the returned vials confirmed that the particulate was a fungal microbial contaminant. See the Firm Press Release for a listing of recalled lot numbers.

    RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [03/25/2011 - Press Release - APP Pharmaceuticals]

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