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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