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Halaven Side Effects

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Common Halaven Side Effects


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

Neutropenia (60)
Leukopenia (51)
Febrile Neutropenia (47)
Interstitial Lung Disease (40)
Pneumonia (30)
Stomatitis (25)
Pyrexia (24)
Pleural Effusion (23)
Anaemia (18)
Malignant Neoplasm Progression (18)
Nausea (17)
Thrombocytopenia (16)
Dyspnoea (15)
Neuropathy Peripheral (15)
Sepsis (14)
Fatigue (13)
Asthenia (13)
Lymphopenia (12)
Malaise (12)
Cardiac Failure (11)

➢ 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.

Halaven Side Effects Reported to FDA



Halaven Side Effect Report#9399902
Ischaemic Stroke, Aphasia, Dysphagia
This is a report of a 79-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Halaven (dosage: 1.23 Mg/m2 (1.98 Mg), start time:
Jun 28, 2013), combined with: NA. and developed a serious reaction and side effect(s): Ischaemic Stroke, Aphasia, Dysphagia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Ischaemic Stroke side effect. The patient was hospitalized.
Halaven Side Effect Report#9387437
Arthritis, Arthralgia, Arthralgia
This report suggests a potential Halaven Arthritis side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: breast cancer and used Halaven (dosage: NA) starting NS. After starting Halaven the patient began experiencing various side effects, including: Arthritis, Arthralgia, ArthralgiaAdditional drugs used concurrently: NA. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arthritis, may still occur.
Halaven Side Effect Report#9377551
Macular Oedema, Retinal Haemorrhage
This Macular Oedema problem was reported by a physician from DE. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 24, 2012 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time:
  • Lapatinib
  • Trastuzumab
  • Trastuzumab
When using Halaven, the patient experienced the following unwanted symptoms/side effects: Macular Oedema, Retinal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Macular Oedema, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9372283
Formication, Chest Pain, Conjunctivitis, Dyspnoea, Stomatitis, Nausea, Vomiting, Alopecia
This Formication side effect was reported by a physician from IT. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Halaven (drug dosage: NA), which was initiated on
Mar 27, 2013. Concurrently used drugs:
  • Ranidil
  • Ondansetron
  • Soldesam
.After starting to take Halaven the consumer reported adverse symptoms, such as: Formication, Chest Pain, Conjunctivitis, Dyspnoea, Stomatitis, Nausea, Vomiting, AlopeciaThese side effects may potentially be related to Halaven.
Halaven Side Effect Report#9369352
Vocal Cord Paralysis, Neuropathy Peripheral
This is a report of a 70-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Halaven (dosage: NA, start time:
Dec 19, 2012), combined with:
  • Aloxi
  • Dexamethasone
  • Hydrocodone-acetaminophen (10-325 Mg)
  • Amiodarone
  • Carvedilol
  • Fluconazole
and developed a serious reaction and side effect(s): Vocal Cord Paralysis, Neuropathy Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Vocal Cord Paralysis side effect. The patient was hospitalized.
Halaven Side Effect Report#9364404
Spinal Pain
This report suggests a potential Halaven Spinal Pain side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: breast cancer and used Halaven (dosage: NA) starting
Jun 25, 2013. After starting Halaven the patient began experiencing various side effects, including: Spinal PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Spinal Pain, may still occur.
Halaven Side Effect Report#9363720
Toxicity To Various Agents, Disease Progression, Neutropenia, Blood Test Abnormal
This Toxicity To Various Agents problem was reported by a physician from CA. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
May 09, 2013 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time: NA. When using Halaven, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Disease Progression, Neutropenia, Blood Test AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9360852
Disease Progression, Cauda Equina Syndrome, Anaemia
This Disease Progression side effect was reported by a physician from DE. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer metastatic.The patient was prescribed Halaven (drug dosage: NA), which was initiated on
Jun 29, 2011. Concurrently used drugs:
  • Sterofundin
  • Aprepitant
  • Dexamethasone
  • Pegfilgrastim
  • Zoledronic Acid
.After starting to take Halaven the consumer reported adverse symptoms, such as: Disease Progression, Cauda Equina Syndrome, AnaemiaThese side effects may potentially be related to Halaven.
Halaven Side Effect Report#9357920
Pneumonia, Diplegia, Headache
This is a report of a 75-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Halaven (dosage: NA, start time:
Dec 14, 2011), combined with: NA. and developed a serious reaction and side effect(s): Pneumonia, Diplegia, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Pneumonia side effect. The patient was hospitalized.
Halaven Side Effect Report#9356042
Acute Respiratory Distress Syndrome
This report suggests a potential Halaven Acute Respiratory Distress Syndrome side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: breast cancer and used Halaven (dosage: 1.8 Mg) starting 2013. After starting Halaven the patient began experiencing various side effects, including: Acute Respiratory Distress SyndromeAdditional drugs used concurrently: NA. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Respiratory Distress Syndrome, may still occur.
Halaven Side Effect Report#9345928
Metastases To Lung, Metastases To Liver, Pneumonia, Decreased Appetite, Neutropenia, Nausea, Pyrexia, Red Blood Cell Count Decreased
This Metastases To Lung problem was reported by a consumer or non-health professional from CA. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
May 10, 2013 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time:
  • Asa
  • Metformin
When using Halaven, the patient experienced the following unwanted symptoms/side effects: Metastases To Lung, Metastases To Liver, Pneumonia, Decreased Appetite, Neutropenia, Nausea, Pyrexia, Red Blood Cell Count DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Metastases To Lung, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9345899
Hepatic Function Abnormal, Leukopenia
This Hepatic Function Abnormal side effect was reported by a physician from JP. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer recurrent.The patient was prescribed Halaven (drug dosage: NA), which was initiated on
Jun 19, 2013. Concurrently used drugs: NA..After starting to take Halaven the consumer reported adverse symptoms, such as: Hepatic Function Abnormal, LeukopeniaThese side effects may potentially be related to Halaven.
Halaven Side Effect Report#9339136
Blood Alkaline Phosphatase Increased, Hypertransaminasaemia, Constipation, Formication, Stomatitis
This is a report of a 39-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: breast cancer recurrent, who was treated with Halaven (dosage: NA, start time:
Feb 28, 2013), combined with: NA. and developed a serious reaction and side effect(s): Blood Alkaline Phosphatase Increased, Hypertransaminasaemia, Constipation, Formication, Stomatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Blood Alkaline Phosphatase Increased side effect.
Halaven Side Effect Report#9336990
Pancytopenia, Septic Shock
This report suggests a potential Halaven Pancytopenia side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: breast cancer and used Halaven (dosage: NA) starting 201304. After starting Halaven the patient began experiencing various side effects, including: Pancytopenia, Septic ShockAdditional drugs used concurrently:
  • G-csf
  • G-csf
  • Avlocardyl
  • Durogesic
  • Stilnox
  • Ogast
  • Alprazolam
  • Fortimel
Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancytopenia, may still occur.
Halaven Side Effect Report#9336501
Extravasation, Oedema
This Extravasation problem was reported by a physician from FR. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic,anaemia. On
May 21, 2013 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time:
  • Ferrous Injection
When using Halaven, the patient experienced the following unwanted symptoms/side effects: Extravasation, OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extravasation, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9334398
Hepatic Failure, Hepatomegaly, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
This Hepatic Failure side effect was reported by a physician from ES. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Halaven (drug dosage: NA), which was initiated on
Jan 30, 2013. Concurrently used drugs:
  • Elica
  • Ibuprofen
  • Omeprazol
  • Dexametasone
  • Acetaminophen
.After starting to take Halaven the consumer reported adverse symptoms, such as: Hepatic Failure, Hepatomegaly, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase IncreasedThese side effects may potentially be related to Halaven. The patient was hospitalized.
Halaven Side Effect Report#9333110
Neoplasm Skin, Infusion Site Pain, Catheter Site Bruise, Musculoskeletal Pain, Wound, Abdominal Distension, Weight Decreased, Arthralgia, Urinary Tract Infection
This is a report of a 48-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Halaven (dosage: NA, start time:
May 13, 2013), combined with:
  • Hydromorphone
  • Metadol
  • Metadol
  • Cymbalta
  • Cymbalta
  • Oxazepam
  • Oxazepam
  • Senokot
and developed a serious reaction and side effect(s): Neoplasm Skin, Infusion Site Pain, Catheter Site Bruise, Musculoskeletal Pain, Wound, Abdominal Distension, Weight Decreased, Arthralgia, Urinary Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Neoplasm Skin side effect.
Halaven Side Effect Report#9333079
Eyelid Ptosis
This report suggests a potential Halaven Eyelid Ptosis side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: breast cancer and used Halaven (dosage: NA) starting
Mar 01, 2013. After starting Halaven the patient began experiencing various side effects, including: Eyelid PtosisAdditional drugs used concurrently:
  • Zithromac
  • Resplen
  • Mucodyne
  • Loxoprofen Na
  • Opso
  • Novamin
  • Omeprazole
  • Methycool
The patient was hospitalized. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eyelid Ptosis, may still occur.
Halaven Side Effect Report#9332913
Tracheobronchitis, Febrile Neutropenia
This Tracheobronchitis problem was reported by a physician from IT. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Nov 21, 2012 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time: NA. When using Halaven, the patient experienced the following unwanted symptoms/side effects: Tracheobronchitis, Febrile NeutropeniaThe 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 Tracheobronchitis, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9308065
Haematoma, Mass
This Haematoma side effect was reported by a physician from FR. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Halaven (drug dosage: NA), which was initiated on 201301. Concurrently used drugs: NA..After starting to take Halaven the consumer reported adverse symptoms, such as: Haematoma, MassThese side effects may potentially be related to Halaven.
Halaven Side Effect Report#9307734
Hip Fracture, Sensation Of Foreign Body, Dysphagia, Pharyngeal Oedema, Musculoskeletal Chest Pain, Gastroenteritis Viral, Oropharyngeal Pain, Alopecia, Pain In Extremity
This is a report of a 43-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Halaven (dosage: NA, start time:
Aug 08, 2012), combined with:
  • Hycodon
  • Calcium Magnesium
  • Zinc
and developed a serious reaction and side effect(s): Hip Fracture, Sensation Of Foreign Body, Dysphagia, Pharyngeal Oedema, Musculoskeletal Chest Pain, Gastroenteritis Viral, Oropharyngeal Pain, Alopecia, Pain In Extremity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Hip Fracture side effect.
Halaven Side Effect Report#9305763
Interstitial Lung Disease, Febrile Neutropenia
This report suggests a potential Halaven Interstitial Lung Disease side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: breast cancer recurrent and used Halaven (dosage: NA) starting
Jan 28, 2013. After starting Halaven the patient began experiencing various side effects, including: Interstitial Lung Disease, Febrile NeutropeniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Interstitial Lung Disease, may still occur.
Halaven Side Effect Report#9292311
Motor Dysfunction, Weight Decreased, Neuropathy Peripheral
This Motor Dysfunction problem was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On 201206 this consumer started treatment with Halaven (dosage: NA). The following drugs were being taken at the same time: NA. When using Halaven, the patient experienced the following unwanted symptoms/side effects: Motor Dysfunction, Weight Decreased, Neuropathy PeripheralAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Motor Dysfunction, may become evident only after a product is in use by the general population.
Halaven Side Effect Report#9292292
Blood Glucose Increased
This Blood Glucose Increased side effect was reported by a consumer or non-health professional from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Halaven (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Halaven the consumer reported adverse symptoms, such as: Blood Glucose IncreasedThese side effects may potentially be related to Halaven.
Halaven Side Effect Report#9292265
Neuropathy Peripheral, Alopecia
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breast cancer, who was treated with Halaven (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Neuropathy Peripheral, Alopecia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Halaven treatment in female patients, resulting in Neuropathy Peripheral side effect.


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The appearance of Halaven 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.

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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.

    Halaven 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.

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    Side Effects reported to FDA: 417

    Halaven safety alerts: No

    Reported deaths: 98

    Reported hospitalizations: 270

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