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Halaven Side Effects

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.

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.

Halaven Side Effects Reported to FDA

The following 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.


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.
Ischaemic Stroke, Aphasia, Dysphagia
This is a report of a 79-year-old female patient (weight: NA) from FR, suffering from the following 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). The consumer presented with:
  • Ischaemic Stroke
  • Aphasia
  • Dysphagia
which developed 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.

Arthritis, Arthralgia
This report suggests a potential Halaven Arthritis, Arthralgia 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. Soon after starting Halaven the patient began experiencing various side effects, including:
  • Arthritis
  • Arthralgia
Drugs used concurrently: NA. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as arthritis, may still occur.

Macular Oedema, Retinal Haemorrhage
This Macular Oedema, Retinal Haemorrhage 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 commencing Halaven, the patient experienced the following unwanted symptoms/side effects:
  • Macular Oedema
  • Retinal Haemorrhage
Although 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.

Formication, Chest Pain, Conjunctivitis, Dyspnoea, Stomatitis, Nausea, Vomiting, Alopecia
This is a report of a 69-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: breast cancer and was treated with Halaven (dosage: NA) starting Mar 27, 2013. Concurrently used drugs:
  • Ranidil
  • Ondansetron
  • Soldesam
Soon after that, the consumer experienced the following side effects:
  • Formication
  • Chest Pain
  • Conjunctivitis
  • Dyspnoea
  • Stomatitis
  • Nausea
  • Vomiting
  • Alopecia
This opens a possibility that Halaven treatment could cause the above reactions, including formication, and some female subjects may be more susceptible.


Vocal Cord Paralysis, Neuropathy Peripheral
A 70-year-old female patient (weight: NA) from US with the following symptoms/conditions: breast cancer metastatic started Halaven treatment (dosage: NA) on Dec 19, 2012. Soon after starting Halaven treatment, the subject experienced various side effects, including:
  • Vocal Cord Paralysis
  • Neuropathy Peripheral
Concurrently used drugs:
  • Aloxi
  • Dexamethasone
  • Hydrocodone-acetaminophen (10-325 Mg)
  • Amiodarone
  • Carvedilol
  • Fluconazole
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Halaven.

Spinal Pain
A 54-year-old female patient from DE (weight: NA) experienced symptoms, such as: breast cancer and was treated with Halaven(dosage: NA). The treatment was initiated on Jun 25, 2013. After that a consumer reported the following side effect(s):
  • Spinal Pain
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Halaven efficacy: NA.The patient was hospitalized.

Toxicity To Various Agents, Disease Progression, Neutropenia, Blood Test Abnormal
In this report, Halaven was administered for the following condition: breast cancer metastatic.A 45-year-old female consumer from CA (weight: NA) started Halaven treatment (dosage: NA) on May 09, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Toxicity To Various Agents
  • Disease Progression
  • Neutropenia
  • Blood Test Abnormal
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Halaven treatment could be related to the listed above side effect(s).

Disease Progression, Cauda Equina Syndrome, Anaemia
This is a report of the following Halaven side effect(s):
  • Disease Progression
  • Cauda Equina Syndrome
  • Anaemia
A 46-year-old female patient from DE (weight: NA) presented with the following condition: breast cancer metastatic and received a treatment with Halaven (dosage: NA) starting: Jun 29, 2011.The following concurrently used drugs could have generated interactions:
  • Sterofundin
  • Aprepitant
  • Dexamethasone
  • Pegfilgrastim
  • Zoledronic Acid
This report suggests that a Halaven treatment could be associated with the listed above side effect(s).

Pneumonia, Diplegia, Headache
This Halaven report was submitted by a 75-year-old female consumer from DE (weight: NA). The patient was diagnosed with: breast cancer metastatic and Halaven was administered (dosage: NA) starting: Dec 14, 2011. The consumer developed a set of symptoms:
  • Pneumonia
  • Diplegia
  • Headache
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Halaven treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Acute Respiratory Distress Syndrome
This is a report of a possible correlation between Halaven use and the following symptoms/side effect(s):
  • Acute Respiratory Distress Syndrome
which could contribute to an assessment of Halaven risk profile.A 51-year-old female consumer from FR (weight: NA) was suffering from breast cancer and was treated with Halaven (dosage: 1.8 Mg) starting 2013.Other concurrent medications: NA.

Metastases To Lung, Metastases To Liver, Pneumonia, Decreased Appetite, Neutropenia, Nausea, Pyrexia, Red Blood Cell Count Decreased
A 53-year-old female patient from CA (weight: NA) presented with the following symptoms: breast cancer metastatic and after a treatment with Halaven (dosage: NA) experienced the following side effect(s):
  • Metastases To Lung
  • Metastases To Liver
  • Pneumonia
  • Decreased Appetite
  • Neutropenia
  • Nausea
  • Pyrexia
  • Red Blood Cell Count Decreased
The treatment was started on May 10, 2013. Halaven was used in combination with the following drugs:
  • Asa
  • Metformin
This report could alert potential Halaven consumers.

Hepatic Function Abnormal, Leukopenia
In this report, a 54-year-old female patient from JP (weight: NA) was affected by a possible Halaven side effect.The patient was diagnosed with breast cancer recurrent. After a treatment with Halaven (dosage: NA, start date: Jun 19, 2013), the patient experienced the following side effect(s):
  • Hepatic Function Abnormal
  • Leukopenia
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Halaven treatment.

Blood Alkaline Phosphatase Increased, Hypertransaminasaemia, Constipation, Formication, Stomatitis
This is a report of a 39-year-old female patient from IT (weight: NA), who used Halaven (dosage: NA) for a treatment of breast cancer recurrent. After starting a treatment on Feb 28, 2013, the patient experienced the following side effect(s):
  • Blood Alkaline Phosphatase Increased
  • Hypertransaminasaemia
  • Constipation
  • Formication
  • Stomatitis
The following drugs could possibly have interacted with the Halaven treatment NA.Taken together, these observations suggest that a Halaven treatment could be related to side effect(s), such as Blood Alkaline Phosphatase Increased, Hypertransaminasaemia, Constipation, Formication, Stomatitis.

Pancytopenia, Septic Shock
This pancytopenia side effect was reported by a physician from FR. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer. The patient was prescribed Halaven (dosage: NA), which was started on 201304. Concurrently used drugs:
  • G-csf
  • G-csf
  • Avlocardyl
  • Durogesic
  • Stilnox
  • Ogast
  • Alprazolam
  • Fortimel
When starting to take Halaven the consumer reported the following symptoms:
  • Pancytopenia
  • Septic Shock
These side effects may potentially be related to Halaven.

Extravasation, Oedema
This is a Halaven side effect report of a 34-year-old female patient (weight:NA) from FR, suffering from the following symptoms/conditions: breast cancer metastatic,anaemia, who was treated with Halaven (dosage:NA, start time: May 21, 2013), combined with:
  • Ferrous Injection
, and developed a serious reaction and a extravasation side effect. The patient presented with:
  • Extravasation
  • Oedema
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Halaven treatment in female patients suffering from breast cancer metastatic,anaemia, resulting in extravasation.

Hepatic Failure, Hepatomegaly, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased
This report suggests a potential Halaven hepatic failure side effect(s) that can have serious consequences. A 49-year-old female patient from ES (weight:NA) was diagnosed with the following health condition(s): breast cancer and used Halaven (dosage: NA) starting Jan 30, 2013. Soon after starting Halaven the patient began experiencing various side effects, including:
  • Hepatic Failure
  • Hepatomegaly
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
  • Blood Alkaline Phosphatase Increased
Drugs used concurrently:
  • Elica
  • Ibuprofen
  • Omeprazol
  • Dexametasone
  • Acetaminophen
The patient was hospitalized. Although Halaven demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hepatic failure, may still occur.

Neoplasm Skin, Infusion Site Pain, Catheter Site Bruise, Musculoskeletal Pain, Wound, Abdominal Distension, Weight Decreased, Arthralgia, Urinary Tract Infection
This neoplasm skin problem was reported by a consumer or non-health professional from CA. A 48-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): breast cancer metastatic.On May 13, 2013 a consumer started treatment with Halaven (dosage: NA). The following drugs/medications were being taken at the same time:
  • Hydromorphone
  • Metadol
  • Metadol
  • Cymbalta
  • Cymbalta
  • Oxazepam
  • Oxazepam
  • Senokot
When commencing Halaven, the patient experienced the following unwanted symptoms /side effects:
  • Neoplasm Skin
  • Infusion Site Pain
  • Catheter Site Bruise
  • Musculoskeletal Pain
  • Wound
  • Abdominal Distension
  • Weight Decreased
  • Arthralgia
  • Urinary Tract Infection
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as neoplasm skin, may become evident only after a product is in use by the general population.

Eyelid Ptosis
This is a Halaven side effect report of a 47-year-old female patient (weight: NA) from JP. The patient developed the following symptoms/conditions: breast cancer and was treated with Halaven (dosage: NA) starting Mar 01, 2013. Concurrently used drugs:
  • Zithromac
  • Resplen
  • Mucodyne
  • Loxoprofen Na
  • Opso
  • Novamin
  • Omeprazole
  • Methycool
Soon after that, the consumer experienced the following of symptoms:
  • Eyelid Ptosis
The patient was hospitalized. This opens a possibility that Halaven could cause eyelid ptosis and that some female patients may be more susceptible.

Tracheobronchitis, Febrile Neutropenia
A 58-year-old female patient (weight: NA) from IT with the following symptoms: breast cancer started Halaven treatment (dosage: NA) on Nov 21, 2012. Soon after starting Halaven treatment, the consumer experienced several side effects, including:
  • Tracheobronchitis
  • Febrile Neutropenia
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Halaven side effects, such as tracheobronchitis.

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 (dosage: NA), which was started on 201301. Concurrently used drugs: NA..When starting to take Halaven the consumer reported symptoms, such as:
  • Haematoma
  • Mass
These side effects may potentially be related to Halaven.

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 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). The consumer presented with:
  • Hip Fracture
  • Sensation Of Foreign Body
  • Dysphagia
  • Pharyngeal Oedema
  • Musculoskeletal Chest Pain
  • Gastroenteritis Viral
  • Oropharyngeal Pain
  • Alopecia
  • Pain In Extremity
which developed 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.

Interstitial Lung Disease, Febrile Neutropenia
This report suggests a potential Halaven Interstitial Lung Disease, Febrile Neutropenia 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. Soon after starting Halaven the patient began experiencing various side effects, including:
  • Interstitial Lung Disease
  • Febrile Neutropenia
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.

Motor Dysfunction, Weight Decreased, Neuropathy Peripheral
This Motor Dysfunction, Weight Decreased, Neuropathy Peripheral 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 commencing Halaven, the patient experienced the following unwanted symptoms/side effects:
  • Motor Dysfunction
  • Weight Decreased
  • Neuropathy Peripheral
Although 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.

Blood Glucose Increased
This is a report of a 70-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: breast cancer and was treated with Halaven (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Blood Glucose Increased
This opens a possibility that Halaven treatment could cause the above reactions, including blood glucose increased, and some male subjects may be more susceptible.

Neuropathy Peripheral, Alopecia
A 56-year-old female patient (weight: NA) from US with the following symptoms/conditions: breast cancer started Halaven treatment (dosage: NA) on NS. Soon after starting Halaven treatment, the subject experienced various side effects, including:
  • Neuropathy Peripheral
  • Alopecia
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Halaven.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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    Side Effects reported to FDA: 417

    Halaven safety alerts: No

    Reported deaths: 98

    Reported hospitalizations: 270

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