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Aloxi (Palonosetron) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aloxi (Palonosetron) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (19)
Death (2)
Life Threatening Events (3)
Disability (1)

Reports by Reaction Type

Abdominal Pain (2)Weight Decreased (2)Tachycardia (2)Polyneuropathy (2)Malaise (2)Anaphylactoid Reaction (2)DRY Mouth (2)Onychoclasis (2)Blood Creatinine Increased (2)Muscle Spasms (2)Blood Phosphorus Increased (2)Blood Potassium Increased (2)

Possible Aloxi side effects in

Reported by a pharmacist from Japan on 2012-08-06

Patient:

Reactions: Anaphylactic Reaction

Drug(s) suspected as cause:
Aloxi
    Dosage: 0.75 mg, once
    Start date: 2012-04-12
    End date: 2012-04-12

Aloxi
    Dosage: 0.75 mg, once
    Start date: 2012-02-09
    End date: 2012-02-11

Fosaprepitant Dimeglumine
    Dosage: 150 mg, once
    Start date: 2012-03-22
    End date: 2012-03-22

Aloxi
    Dosage: 0.75 mg, qd
    Start date: 2012-01-11
    End date: 2012-01-13

Polaramine
    Dosage: 5 mg, once
    Start date: 2012-04-12
    End date: 2012-04-12

Fosaprepitant Dimeglumine
    Dosage: 150 mg, once
    Start date: 2012-04-12
    End date: 2012-04-12

Other drugs received by patient: Ranitidine Hydrochloride; Granisetron; Dexamethasone Sodium Phosphate; Restamin; Ranitidine Hydrochloride; Ranitidine Hydrochloride; Restamin; Ranitidine Hydrochloride; Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Restamin



Possible Aloxi side effects in female

Reported by a physician from Japan on 2012-07-20

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Large Intestine Perforation, Ileal Perforation, Large Intestinal Ulcer Haemorrhage, Abdominal Abscess, Disease Progression

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Aloxi
    Indication: Prophylaxis
    Start date: 2012-03-12
    End date: 2012-03-26

Levoleucovorin Calcium
    Indication: Colon Cancer Metastatic
    Start date: 2012-02-27
    End date: 2012-03-26

Avastin
    Indication: Colon Cancer Metastatic
    Start date: 2012-03-12
    End date: 2012-03-26

Other drugs received by patient: Irinotecan HCL; Decadron; Fluorouracil; Fluorouracil



Possible Aloxi side effects in 45 year old female

Reported by a physician from Japan on 2012-07-02

Patient: 45 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Docetaxel
    Dosage: 75 mg/m2, qd, iv drip, iv drip
    Indication: Breast Cancer
    Start date: 2011-06-14
    End date: 2011-06-14

Docetaxel
    Dosage: 75 mg/m2, qd, iv drip, iv drip
    Indication: Breast Cancer
    Start date: 2011-07-06
    End date: 2011-07-06

Aloxi
    Dosage: 0.75 mg, single, intravenous
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2011-06-14
    End date: 2011-06-14

Aloxi
    Dosage: 0.75 mg, single, intravenous
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2011-07-06
    End date: 2011-07-06

Other drugs received by patient: Cyclophosphamide; Dexamethasone Sodium Phosphate; Kytril; Decadron



Possible Aloxi side effects in 58 year old male

Reported by a physician from Japan on 2012-07-02

Patient: 58 year old male

Reactions: Electrocardiogram QT Prolonged, Blood Chloride Decreased, Tachycardia, Atrial Fibrillation, Blood Sodium Decreased, Blood Glucose Increased

Drug(s) suspected as cause:
Aloxi

Other drugs received by patient: Adalat; Teleminsoft (Bisacodyl); Towarat (Nifedipine); Hachiazule (Sodium Bicarbonate, Sodium Gualenate); Mannitol; Flomox (Cefcapene Pivoxil Hydrochloride); Amaryl; Shitei (Herbal Medicine); Selbex (Teprenone); Cisplatin; Calblock (Azelnidipine); Humacart R (Insulin Human); Magmitt (Magnesium Oxide); Gemzar; Soldem 3A (Carbohydrates Nos, Potassium Chloride, Sodium Chloride, SOD; Lasix; Dexamethasone Sodium Phosphate; Adofeed (Flurbiprofen); Humulin R; Magnesium Hydroxide TAB; Yodel (Senna Alexandrina); Isodine (Povidone-Iodine); Glycerol 2.6%; Humulin N; Humalog; Heparin



Possible Aloxi side effects in 45 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 45 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Aloxi
    Dosage: 0.75 mg, single, intravenous
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2011-06-14
    End date: 2011-06-14

Aloxi
    Dosage: 0.75 mg, single, intravenous
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2011-07-06
    End date: 2011-07-06

Docetaxel
    Dosage: 75 mg/m2, qd, iv drip
    Indication: Breast Cancer
    Start date: 2011-06-14
    End date: 2011-06-14

Docetaxel
    Dosage: 75 mg/m2, qd, iv drip
    Indication: Breast Cancer
    Start date: 2011-07-06
    End date: 2011-07-06

Other drugs received by patient: Kytril; Decadron (Dexamethsone); Dexamethasone Sodium Phosphate



Possible Aloxi side effects in

Reported by a physician from United States on 2012-06-15

Patient:

Reactions: Hypotension, Tachycardia, Adverse Reaction

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Aloxi

Fosaprepitant Dimeglumine

Fosaprepitant Dimeglumine
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Aloxi side effects in male

Reported by a individual with unspecified qualification from Switzerland on 2012-06-15

Patient: male, weighing 3.0 kg (6.5 pounds)

Reactions: Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Epirubicin Hydrochloride
    Start date: 2011-08-09
    End date: 2011-08-09

Epirubicin Hydrochloride
    Start date: 2011-07-18
    End date: 2011-07-18

Fluorouracil
    Start date: 2011-08-09
    End date: 2011-08-09

Emend
    Start date: 2011-07-18
    End date: 2011-07-20

Aloxi
    Start date: 2011-08-09
    End date: 2011-08-09

Aloxi
    Start date: 2011-07-18
    End date: 2011-07-18

Fluorouracil
    Start date: 2011-07-18
    End date: 2011-07-18

Cyclophosphamide
    Start date: 2011-07-18
    End date: 2011-07-18

Cyclophosphamide
    Start date: 2011-08-09
    End date: 2011-08-09



Possible Aloxi side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: 65 year old male, weighing 78.8 kg (173.4 pounds)

Reactions: Contusion, Ecchymosis, Gastric Haemorrhage, Idiopathic Thrombocytopenic Purpura, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aloxi
    Dosage: 0.50 mg, single, oral
    Administration route: Oral
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-03-22
    End date: 2012-03-22

Palonosetron (Palonosetron) 0.50mg
    Dosage: 0.50 mg, single, oral,
    Administration route: Oral
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-02-23
    End date: 2012-02-23

Palonosetron (Palonosetron) 0.50mg
    Dosage: 0.50 mg, single, oral,
    Administration route: Oral
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-03-08
    End date: 2012-03-08



Possible Aloxi side effects in 45 year old female

Reported by a pharmacist from Japan on 2012-04-23

Patient: 45 year old female

Reactions: Flushing, Dyspnoea, Cold Sweat, Feeling Cold

Drug(s) suspected as cause:
Fosaprepitant Dimeglumine
    Dosage: drip
    Start date: 2012-04-12
    End date: 2012-04-12

Fosaprepitant Dimeglumine
    Dosage: drip
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-03-22
    End date: 2012-03-22

Fosaprepitant Dimeglumine
    Dosage: drip
    Indication: Nausea
    Start date: 2012-03-22
    End date: 2012-03-22

Aloxi
    Dosage: drip
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-04-12
    End date: 2012-04-12

Aloxi
    Dosage: drip
    Indication: Nausea
    Start date: 2012-04-12
    End date: 2012-04-12

Fosaprepitant Dimeglumine
    Dosage: drip
    Start date: 2012-04-12
    End date: 2012-04-12

Chlorpheniramine Maleate
    Indication: Urticaria
    Start date: 2012-04-12
    End date: 2012-04-12

Other drugs received by patient: Dexamethasone Sodium Phosphate; Ranitidine Hydrochloride



Possible Aloxi side effects in 59 year old male

Reported by a physician from Japan on 2012-04-09

Patient: 59 year old male

Reactions: Subileus

Drug(s) suspected as cause:
Doxorubicin HCL
    Dosage: intravenous
    Indication: Lymphoma
    Start date: 2012-02-09

Prednisone TAB
    Indication: Lymphoma
    Start date: 2012-02-09

Aloxi
    Dosage: intravenous
    Indication: Prophylaxis of Nausea and Vomiting
    Start date: 2012-02-09

Bendamustine Hydrochloride (Bendamustine Hydrochloride)
    Indication: Lymphoma

Oncovin
    Dosage: intravenous
    Indication: Lymphoma
    Start date: 2012-02-09

Other drugs received by patient: Rituxan; Eddoxan (Cyclophosphamdie Monohydrate)



Possible Aloxi side effects in male

Reported by a pharmacist from United States on 2012-02-21

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Pruritus, Stridor, Unresponsive To Stimuli, Pulse Absent

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: 1000 mg every 3 weeks iv
    Indication: Mesothelioma
    Start date: 2010-07-29
    End date: 2010-12-27

Alimta
    Dosage: 1000 mg every 3 weeks iv
    Indication: Mesothelioma
    Start date: 2011-12-06
    End date: 2012-01-30

Aloxi
    Dosage: 0.25 mg every 3 weeks iv
    Indication: Antiemetic Supportive Care

Other drugs received by patient: Cisplatin



Possible Aloxi side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-02

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lortab

Aloxi

Compazine

Zometa



Possible Aloxi side effects in 81 year old female

Reported by a physician from Switzerland on 2012-01-30

Patient: 81 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Malaise, Chest Discomfort, Type I Hypersensitivity, Rash, Hypertension

Drug(s) suspected as cause:
Aloxi
    Dosage: 0.25 mg, unk
    Start date: 2011-11-25
    End date: 2011-11-25

Eloxatin
    Dosage: 100 mg, 1x/day
    Indication: Colorectal Cancer
    Start date: 2011-11-25
    End date: 2011-11-25

Solu-Medrol
    Dosage: 125 mg, unk
    Start date: 2011-11-25
    End date: 2011-11-25

Clemastine Fumarate
    Dosage: 2 mg, unk
    Start date: 2011-11-25
    End date: 2011-11-25

Zantac
    Dosage: 50 mg, unk
    Start date: 2011-11-25
    End date: 2011-11-25

Other drugs received by patient: Vitamin D; Symbicort; Calcium; Magnesium



Possible Aloxi side effects in 81 year old female

Reported by a physician from Switzerland on 2012-01-25

Patient: 81 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Chest Discomfort, Malaise, Type I Hypersensitivity, Rash, Hypertension

Drug(s) suspected as cause:
Aloxi
    Dosage: .25mg per day
    Indication: Premedication
    Start date: 2011-11-25
    End date: 2011-11-25

Clemastine Fumarate
    Dosage: 2mg per day
    Indication: Premedication
    Start date: 2011-11-25
    End date: 2011-11-25

Solu-Medrol
    Dosage: 125mg per day
    Indication: Premedication
    Start date: 2011-11-25
    End date: 2011-11-25

Eloxatin
    Dosage: 100mg per day
    Indication: Colorectal Cancer
    Start date: 2011-11-25
    End date: 2011-11-25

Zantac
    Dosage: 50mg per day
    Indication: Premedication
    Start date: 2011-11-25
    End date: 2011-11-25

Other drugs received by patient: Calcium; Symbicort; Vitamin D; Magnesium Sulfate



Possible Aloxi side effects in 76 year old female

Reported by a pharmacist from Germany on 2012-01-11

Patient: 76 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Decreased, Palmar-Plantar Erythrodysaesthesia Syndrome, Skin Striae, Polyneuropathy, Dysgeusia, DRY Mouth, Pollakiuria, Onychoclasis, Muscle Spasms

Drug(s) suspected as cause:
Fortecortin
    Dosage: 12 times between 12may11 + 28jul11 3rd admin: 31mar11.

Emend
    Dosage: also 80mg 10mar11, 17feb11. 3rd admin: 31mar11.
    Administration route: Oral

Aloxi
    Dosage: 1df= 1amp in 100 ml sodium chloride 0.9% 3rd admin: 31mar11.

Mesna
    Dosage: also on 10mar11, 31mar11 + 21apr11. 3rd admin: 31mar11.
    Administration route: Oral
    Start date: 2011-02-17

Fenistil
    Dosage: 1 df= ampoule. 12 times between 12may11 + 28jul11

Cyclophosphamide
    Dosage: 1 df= 600mg/qm cycle durn: 21 days after 3 admin event occured 3rd admin: 31mar11.

Zofran
    Dosage: on 100ml sodium chloride sloutin 12 times between 12may11 + 28jul11

Taxol
    Dosage: 1 df= 80mg/qm 12 times between 12may11 + 28jul11.
    Indication: Breast Cancer

Epirubicin
    Dosage: 90 mg/qm bsa cycle durn: 21 days after 3 admin event occured also 972mg 3rd admin: 31mar11.

Ranitidine
    Dosage: 1 df= 1 ampoule 12 times between 12may11 + 28jul11



Possible Aloxi side effects in 76 year old female

Reported by a physician from Germany on 2011-12-09

Patient: 76 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Decreased, Palmar-Plantar Erythrodysaesthesia Syndrome, Skin Striae, Polyneuropathy, Dysgeusia, DRY Mouth, Pollakiuria, Onychoclasis, Muscle Spasms

Drug(s) suspected as cause:
Taxol
    Dosage: 1 df= 80mg/qm
    Indication: Breast Cancer

Cyclophosphamide
    Dosage: 1 df= 600mg/qm cycle durn: 21 days

Uromitexan
    Administration route: Oral

Fenistil
    Dosage: 1 df= ampoule

Emend
    Dosage: also 80mg 10mar11, 17feb11.
    Administration route: Oral

Zofran
    Dosage: on 100ml sodium chloride sloutin

Ranitidine
    Dosage: 1 df= 1 ampoule

Aloxi
    Dosage: 1df= 1amp in 100 ml sodium chloride 0.9%

Epirubicin
    Dosage: 90 mg/qm bsa cycle durn: 21 days

Fortecortin



Possible Aloxi side effects in male

Reported by a individual with unspecified qualification from United States on 2011-11-09

Patient: male, weighing 75.9 kg (166.9 pounds)

Reactions: Blood Calcium Decreased, Tumour Lysis Syndrome, Blood Phosphorus Increased, Blood Uric Acid Increased, Blood Potassium Increased, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, every 1 month

Aloxi
    Dosage: 0.25 mg, unk
    Indication: Antiemetic Supportive Care
    Start date: 2010-04-01

Velcade
    Dosage: 2.43 mg,day 1, 4, 8, 11
    Indication: Multiple Myeloma
    Start date: 2010-04-01
    End date: 2010-04-12

Zometa
    Dosage: 4 mg/5ml
    Indication: Multiple Myeloma
    Start date: 2010-04-01

Dexamethasone
    Dosage: 20 mg, day 1, 4, 8 and 11
    Indication: Multiple Myeloma
    Start date: 2010-04-01
    End date: 2010-04-12

Other drugs received by patient: Doxi ^om^; Revlimid; Lactulose; Percocet; Hemodialysis; Acyclovir; Oxycontin; Fentanyl-100



Possible Aloxi side effects in male

Reported by a individual with unspecified qualification from United States on 2011-11-09

Patient: male, weighing 75.9 kg (166.9 pounds)

Reactions: Blood Calcium Decreased, Tumour Lysis Syndrome, Blood Phosphorus Increased, Blood Uric Acid Increased, Blood Potassium Increased, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aloxi
    Dosage: 0.25 mg, unk
    Indication: Antiemetic Supportive Care
    Start date: 2010-04-01

Zometa
    Dosage: 4 mg/5ml
    Indication: Multiple Myeloma
    Start date: 2010-04-01

Dexamethasone
    Dosage: 20 mg, day 1, 4, 8 and 11
    Indication: Multiple Myeloma
    Start date: 2010-04-01
    End date: 2010-04-12

Zometa
    Dosage: 4 mg, every 1 month

Velcade
    Dosage: 2.43 mg,day 1, 4, 8, 11
    Indication: Multiple Myeloma
    Start date: 2010-04-01
    End date: 2010-04-12

Other drugs received by patient: Fentanyl-100; Hemodialysis; Acyclovir; Oxycontin; Doxi ^om^; Revlimid; Lactulose; Percocet



Possible Aloxi side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-10-26

Patient: 34 year old female

Reactions: Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Breast Cancer
    Start date: 2011-08-09
    End date: 2011-08-09

Cyclophosphamide
    Start date: 2011-07-18
    End date: 2011-07-18

Epirubicin Hydrochloride
    Start date: 2011-07-18
    End date: 2011-07-18

Emend
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-07-18
    End date: 2011-07-20

Aloxi
    Start date: 2011-07-18
    End date: 2011-07-18

Fluorouracil
    Indication: Breast Cancer
    Start date: 2011-08-09
    End date: 2011-08-09

Fluorouracil
    Start date: 2011-07-18
    End date: 2011-07-18

Epirubicin Hydrochloride
    Indication: Breast Cancer
    Start date: 2011-08-09
    End date: 2011-08-09

Aloxi
    Indication: Breast Cancer
    Start date: 2011-08-09
    End date: 2011-08-09

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