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Anzemet Side Effects

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Common Anzemet Side Effects


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

Asthenia (5)
Bone Debridement (4)
Back Pain (4)
Bone Disorder (4)
Bone Density Decreased (4)
Chills (4)
Candidiasis (4)
Bone Pain (4)
Cardio-respiratory Arrest (3)
Androgens Abnormal (3)
Coma (3)
Heart Rate Increased (3)
Dyskinesia (3)
Vomiting (3)
Oxygen Saturation Decreased (2)
Pruritus (2)
Nausea (2)
Hypotension (2)
Hypokinesia (2)
Loss Of Consciousness (2)

➢ 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.

Anzemet Side Effects Reported to FDA



Anzemet Side Effect Report#7428798-9
Fatigue, Vomiting, Malnutrition
This is a report of a 70-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: prophylaxis of nausea and vomiting,dermatitis acneiform, who was treated with Anzemet (dosage: NA, start time:
Feb 14, 2011), combined with:
  • Clindamycin
  • Aloxi (Day 1 Of Chemo Cycle 24jan2011:0.25mg 14feb2011:0.25mg)
  • Cetuximab (No Of Inf:6)
  • Cisplatin (No Of Inf:2)
  • Mannitol
  • Miralax
  • Phenergan Hcl
  • Fluorouracil (No Of Inf:2)
and developed a serious reaction and side effect(s): Fatigue, Vomiting, Malnutrition after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in male patients, resulting in Fatigue side effect. The patient was hospitalized.
Anzemet Side Effect Report#7243539-6
Balance Disorder, Neuropathy Peripheral, Asthenia
This report suggests a potential Anzemet Balance Disorder side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Anzemet (dosage: NA) starting
Sep 20, 2010. After starting Anzemet the patient began experiencing various side effects, including: Balance Disorder, Neuropathy Peripheral, AstheniaAdditional drugs used concurrently:
  • Decadron
  • Dacogen (39 Mg, Intravenous)
Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Balance Disorder, may still occur.
Anzemet Side Effect Report#6416022-5
Resuscitation
This Resuscitation problem was reported by a pharmacist from United States. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 02, 2009 this consumer started treatment with Anzemet (dosage: Dose: 100 Mg In 50 Ml Saline Over 10 Min). The following drugs were being taken at the same time:
  • Dexamethasone
  • Gemzar (Dose: Unk)
When using Anzemet, the patient experienced the following unwanted symptoms/side effects: ResuscitationThe 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 Resuscitation, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#6406159-9
Oncologic Complication
This Oncologic Complication side effect was reported by a pharmacist from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Anzemet (drug dosage: Dose: 100 Mg Prior To Doxil/ Month), which was initiated on
Jun 23, 2008. Concurrently used drugs: NA..After starting to take Anzemet the consumer reported adverse symptoms, such as: Oncologic ComplicationThese side effects may potentially be related to Anzemet.
Anzemet Side Effect Report#6051386-6
Dyskinesia, Facial Neuralgia, Osteonecrosis
This is a report of a 85-year-old female patient (weight: NA) from , suffering from the following health symptoms/conditions: NA, who was treated with Anzemet (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dyskinesia, Facial Neuralgia, Osteonecrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in female patients, resulting in Dyskinesia side effect.
Anzemet Side Effect Report#5728912-7
Malaise, Vomiting
This report suggests a potential Anzemet Malaise side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Anzemet (dosage: Injectable) starting NS. After starting Anzemet the patient began experiencing various side effects, including: Malaise, VomitingAdditional drugs used concurrently:
  • Dilaudid (Injectable)
  • Phenergan (Injectable)
Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Anzemet Side Effect Report#5497949-8
This Sudden Death problem was reported by a health professional from United States. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 10, 2007 this consumer started treatment with Anzemet (dosage: Unk). The following drugs were being taken at the same time:
  • Leucovorin (Unk)
  • Eloxatin (Unk)
  • Fluorouracil (Unk)
  • Decadron (Unk)
When using Anzemet, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sudden Death, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#5411018-4
Abdominal Distension, Abdominal Pain, Colitis Ischaemic, Constipation
This Abdominal Distension side effect was reported by a consumer or non-health professional from Canada. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Anzemet (drug dosage: Dose: 100 Mg 1 H Before Temozolomide On The 1st Day Of Treatment), which was initiated on NS. Concurrently used drugs:
  • Temodal (Dose: 250 Mg, 4 Days/month)
  • Stemetil /00013301/ (Dose: 10 Mg 1 H Before Temozolomide On Days 2 To 4 Of Treatment)
  • Ramipril (nos)
  • Timolol Xe
  • Latanoprost 0.005 %
  • Levothyroxine Sodium
  • Calcium + Vitamin D4 (Dose: 500 Mg + 400 U)
  • Alendronate Sodium
.After starting to take Anzemet the consumer reported adverse symptoms, such as: Abdominal Distension, Abdominal Pain, Colitis Ischaemic, ConstipationThese side effects may potentially be related to Anzemet. The patient was hospitalized.
Anzemet Side Effect Report#5399194-3
Abdominal Distension, Abdominal Pain, Colitis Ischaemic, Constipation
This is a report of a 63-year-old female patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Anzemet (dosage: Dose: 100 Mg 1 H Before Temozolomide On The 1st Day Of Treatment, start time: NS), combined with:
  • Temodal (Dose: 250 Mg, 4 Days/month)
  • Stemetil /00013301/ (Dose: 10 Mg 1 H Before Temozolomide On Days 2 To 4 Of Treatment)
  • Ramipril (nos)
  • Timolol Xe
  • Latanoprost 0.005 %
  • Levothyroxine Sodium
  • Calcium + Vitamin D4 (Dose: 500 Mg + 400 U)
  • Alendronate Sodium
and developed a serious reaction and side effect(s): Abdominal Distension, Abdominal Pain, Colitis Ischaemic, Constipation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in female patients, resulting in Abdominal Distension side effect. The patient was hospitalized.
Anzemet Side Effect Report#5286076-0
Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, Chills
This report suggests a potential Anzemet Androgens Abnormal side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Anzemet (dosage: 100 Mg, Qmo) starting
Oct 01, 2002. After starting Anzemet the patient began experiencing various side effects, including: Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, ChillsAdditional drugs used concurrently:
  • Decadron /net/ (8 Mg, Qmo)
  • Influenza Vaccine
  • Rocaltrol (Unk, Qd)
  • Calcitriol
  • Proscar
  • Zometa (4 Mg Every Month)
  • Taxotere (80 Mg, Qw)
  • Vicodin (Unk, Prn)
Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Androgens Abnormal, may still occur.
Anzemet Side Effect Report#5268223-X
Intestinal Ischaemia, Large Intestine Perforation
This Intestinal Ischaemia problem was reported by a consumer or non-health professional from . A 46-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 23, 2007 this consumer started treatment with Anzemet (dosage: NA). The following drugs were being taken at the same time:
  • Xeloda (Dose: 4 Df)
  • Taxotere
  • Mephameson /00016001/ (Dose: 8mg/2ml)
  • Cisplatin
  • Emend
When using Anzemet, the patient experienced the following unwanted symptoms/side effects: Intestinal Ischaemia, Large Intestine PerforationThe 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 Intestinal Ischaemia, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#5238664-5
Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, Chills
This Androgens Abnormal side effect was reported by a consumer or non-health professional from United States. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Anzemet (drug dosage: 100 Mg, Qmo), which was initiated on
Oct 01, 2002. Concurrently used drugs:
  • Decadron /net/ (8 Mg, Qmo)
  • Influenza Vaccine
  • Rocaltrol (Unk, Qd)
  • Calcitriol
  • Proscar
  • Zometa (4 Mg Every Month)
  • Taxotere (80 Mg, Qw)
  • Vicodin (Unk, Prn)
.After starting to take Anzemet the consumer reported adverse symptoms, such as: Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, ChillsThese side effects may potentially be related to Anzemet.
Anzemet Side Effect Report#5232287-X
Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, Chills
This is a report of a 59-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Anzemet (dosage: 100 Mg, Qmo, start time:
Oct 01, 2002), combined with:
  • Decadron /net/ (8 Mg, Qmo)
  • Influenza Vaccine
  • Rocaltrol (Unk, Qd)
  • Calcitriol
  • Proscar
  • Zometa (4 Mg Every Month)
  • Taxotere (80 Mg, Qw)
  • Vicodin (Unk, Prn)
and developed a serious reaction and side effect(s): Androgens Abnormal, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in male patients, resulting in Androgens Abnormal side effect.
Anzemet Side Effect Report#5192061-X
Abdominal Pain Upper, Blood Pressure Decreased, Haematemesis, Hyperhidrosis, Nausea
This report suggests a potential Anzemet Abdominal Pain Upper side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: nausea,vomiting and used Anzemet (dosage: Ivp X 1) starting
Sep 13, 2006. After starting Anzemet the patient began experiencing various side effects, including: Abdominal Pain Upper, Blood Pressure Decreased, Haematemesis, Hyperhidrosis, NauseaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Upper, may still occur.
Anzemet Side Effect Report#5170415-5
Chills, Hypoaesthesia, Neuropathy, Paraesthesia, Paralysis
This Chills problem was reported by a health professional from United States. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 27, 2006 this consumer started treatment with Anzemet (dosage: Unk). The following drugs were being taken at the same time:
  • Decadron (Unk)
  • Magnesium Sulfate (Unk)
  • Calcium Gluconate (Unk)
  • Eloxatin
When using Anzemet, the patient experienced the following unwanted symptoms/side effects: Chills, Hypoaesthesia, Neuropathy, Paraesthesia, ParalysisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chills, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#5155034-9
Androgen Deficiency, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, Choking
This Androgen Deficiency side effect was reported by a consumer or non-health professional from United States. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Anzemet (drug dosage: 100 Mg, Qmo), which was initiated on
Apr 22, 2002. Concurrently used drugs:
  • Decadron /net/ (8 Mg, Qmo)
  • Influenza Vaccine
  • Rocaltrol
  • Calcitriol
  • Proscar
  • Zometa (4 Mg, Qmo)
  • Taxotere (80 Mg, Qw)
  • Vicodin (Unk, Prn)
.After starting to take Anzemet the consumer reported adverse symptoms, such as: Androgen Deficiency, Asthenia, Back Pain, Bone Debridement, Bone Density Decreased, Bone Disorder, Bone Pain, Candidiasis, ChokingThese side effects may potentially be related to Anzemet.
Anzemet Side Effect Report#5101292-6
Acute Myocardial Infarction, Cardiac Failure, Ejection Fraction Decreased, Electrocardiogram St Segment Depression, Heart Rate Increased, Hypokinesia, Pulmonary Oedema, Tachycardia, Troponin I Increased
This is a report of a 17-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: post procedural vomiting,induction of anaesthesia, who was treated with Anzemet (dosage: NA, start time:
Dec 01, 2002), combined with:
  • Midazolam (Dose: Unk)
  • Dexamethasone Tab
  • Lidocaine
  • Propofol
  • Fentanyl
  • Cisatracurium Besilate
  • Desflurane
  • Nitrous Oxide W/ Oxygen
and developed a serious reaction and side effect(s): Acute Myocardial Infarction, Cardiac Failure, Ejection Fraction Decreased, Electrocardiogram St Segment Depression, Heart Rate Increased, Hypokinesia, Pulmonary Oedema, Tachycardia, Troponin I Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in female patients, resulting in Acute Myocardial Infarction side effect.
Anzemet Side Effect Report#5101291-4
Apnoea, Atrioventricular Block, Bradycardia, Cardiac Arrest, Cardio-respiratory Arrest, Coma, Dyspnoea, Loss Of Consciousness
This report suggests a potential Anzemet Apnoea side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: prophylaxis of nausea and vomiting and used Anzemet (dosage: NA) starting
Feb 19, 1999. After starting Anzemet the patient began experiencing various side effects, including: Apnoea, Atrioventricular Block, Bradycardia, Cardiac Arrest, Cardio-respiratory Arrest, Coma, Dyspnoea, Loss Of ConsciousnessAdditional drugs used concurrently: NA. Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Apnoea, may still occur.
Anzemet Side Effect Report#5004102-0
Accidental Overdose, Cardio-respiratory Arrest, Hypotension, Loss Of Consciousness
This Accidental Overdose problem was reported by a pharmacist from United States. A 88-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: post procedural nausea,post procedural vomiting. On
Feb 08, 2006 this consumer started treatment with Anzemet (dosage: NA). The following drugs were being taken at the same time: NA. When using Anzemet, the patient experienced the following unwanted symptoms/side effects: Accidental Overdose, Cardio-respiratory Arrest, Hypotension, Loss Of ConsciousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Accidental Overdose, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#4973541-6
Abdominal Discomfort, Anaemia, Blood Pressure Diastolic Decreased, Blood Pressure Increased, Body Temperature Increased, Hypovolaemia, Oxygen Saturation Decreased, Pain, Pruritus
This Abdominal Discomfort side effect was reported by a pharmacist from United States. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: nausea.The patient was prescribed Anzemet (drug dosage: 12.5 Mg Iv Q4hours Prn For N/v), which was initiated on
Mar 23, 2006. Concurrently used drugs: NA..After starting to take Anzemet the consumer reported adverse symptoms, such as: Abdominal Discomfort, Anaemia, Blood Pressure Diastolic Decreased, Blood Pressure Increased, Body Temperature Increased, Hypovolaemia, Oxygen Saturation Decreased, Pain, PruritusThese side effects may potentially be related to Anzemet.
Anzemet Side Effect Report#4946410-5
Cardio-respiratory Arrest
This is a report of a 88-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: nausea, who was treated with Anzemet (dosage: NA, start time:
Feb 08, 2006), combined with:
  • Lanoxin
  • Lasix
  • K-dur 10
  • Hyzaar (Dose: 50/12.5)
  • Lovenox
  • Os-cal 500+d
  • Fosamax
and developed a serious reaction and side effect(s): Cardio-respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in female patients, resulting in Cardio-respiratory Arrest side effect.
Anzemet Side Effect Report#4849842-9
Anaphylactic Reaction, Blood Pressure Decreased, Pruritus, Swelling Face
This report suggests a potential Anzemet Anaphylactic Reaction side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: ovarian cancer and used Anzemet (dosage: 100 Mg Q3w Iv) starting
Nov 19, 2003. After starting Anzemet the patient began experiencing various side effects, including: Anaphylactic Reaction, Blood Pressure Decreased, Pruritus, Swelling FaceAdditional drugs used concurrently:
  • Dexamethasone Tab
  • Diphenhydramine Hydrochloride (benadryl /old Form/)
  • Taxol
  • Carboplatin
Although Anzemet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Reaction, may still occur.
Anzemet Side Effect Report#4811223-1
Anxiety, Blood Pressure Immeasurable, Dizziness, Dyspnoea, Nausea, Sensory Disturbance, Vision Blurred
This Anxiety problem was reported by a health professional from United States. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: nausea. On NS this consumer started treatment with Anzemet (dosage: Anzemet 100 Mg Iv). The following drugs were being taken at the same time:
  • Zofran (Zofran 32 Mg Iv)
  • Ativan
  • Decadron
  • Calcium Gluconate
  • Iron
  • Tarceva
  • Coumadin
  • Lasix
When using Anzemet, the patient experienced the following unwanted symptoms/side effects: Anxiety, Blood Pressure Immeasurable, Dizziness, Dyspnoea, Nausea, Sensory Disturbance, Vision BlurredThe 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 Anxiety, may become evident only after a product is in use by the general population.
Anzemet Side Effect Report#4791105-4
Asthma, Disease Recurrence, Pneumonia, Pneumonia Aspiration, Vomiting
This Asthma side effect was reported by a consumer or non-health professional from . A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis of nausea and vomiting.The patient was prescribed Anzemet (drug dosage: NA), which was initiated on
Oct 31, 2002. Concurrently used drugs:
  • Reglan
.After starting to take Anzemet the consumer reported adverse symptoms, such as: Asthma, Disease Recurrence, Pneumonia, Pneumonia Aspiration, VomitingThese side effects may potentially be related to Anzemet.
Anzemet Side Effect Report#4720848-3
Acute Myocardial Infarction, Arteriospasm Coronary, Cardiac Failure, Ejection Fraction Decreased, Electrocardiogram St Segment Depression, Heart Rate Increased, Hypokinesia, Oxygen Saturation Decreased, Pulmonary Oedema
This is a report of a 17-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Anzemet (dosage: Dose: Unk, start time:
Dec 01, 2002), combined with:
  • Midazolam Hcl (Dose: Unk)
  • Dexamethasone
  • Lidocaine
  • Propofol
  • Fentanyl
  • Cisatracurium Besilate
  • Desflurane
  • Nitrous Oxide
and developed a serious reaction and side effect(s): Acute Myocardial Infarction, Arteriospasm Coronary, Cardiac Failure, Ejection Fraction Decreased, Electrocardiogram St Segment Depression, Heart Rate Increased, Hypokinesia, Oxygen Saturation Decreased, Pulmonary Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Anzemet treatment in female patients, resulting in Acute Myocardial Infarction side effect.


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The appearance of Anzemet 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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    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.

    Anzemet 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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    Anzemet Safety Alerts, Active Ingredients, Usage Information

    NDC0088-1202
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAnzemet
    Namedolasetron mesylate
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19970911
    Labelersanofi-aventis U.S. LLC
    Active Ingredient(s)DOLASETRON MESYLATE
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

    Anzemet Dosage, Warnings, Usage.

    Side Effects reported to FDA: 31

    Anzemet safety alerts: 2010

    Reported deaths: 6

    Reported hospitalizations: 11

    Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms

    [Posted 12/17/2010]

    AUDIENCE: Oncology, Cardiology

    ISSUE: FDA notified healthcare professionals that a contraindication is being added to the prescribing information advising that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that Anzemet injection can increase the risk of developing torsade de pointes, an abnormal heart rhythm, which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. Anzemet causes a dose-dependant prolongation in the QT, PR, and QRS intervals on an electrocardiogram.

    BACKGROUND: FDA previously noted cardiovascular safety concerns which suggested Anzemet could cause QT prolongation.  However, limitations of the previous data did not clearly establish the degree to which Anzemet may cause QT prolongation. FDA recommended that the drug sponsor conduct a thorough QT study in adults in order to determine the degree of the prolongation. A pediatric study was not recommended due to the wide variability in heart rate and, thus, QTc interval in the pediatric population. See the Data Summary section of the Drug Safety Communication (DSC) for information that supports this change in the prescribing information.

    RECOMMENDATION: Anzemet should not be used in patients with congenital long-QT syndrome. Hypokalemia and hypomagnesemia should be corrected before administering Anzemet. These electrolytes should be monitored after administration as clinically indicated. Use electrocardiogram monitoring in patients with congestive heart failure, patients with bradycardia, patients with underlying heart disease, the elderly and in patients who are renally impaired who are taking Anzemet. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting because the lower doses used are less likely to affect the electrical activity of the heart and result in abnormal heart rhythms.

    Anzemet tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label.

    See the DSC for additional recommendations for healthcare professionals and for patients.
     

     

    [12/17/2010 - Drug Safety Communication - FDA]

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