This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Arzerra (Ofatumumab) 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 (97)
Death (9)
Life Threatening Events (4)
Disability (4)
Reports by Reaction Type
Infusion Related Reaction (11),
Neutropenia (11),
Febrile Neutropenia (9),
Diarrhoea (6),
Pyrexia (5),
Neuropathy Peripheral (5),
Dyspnoea (5),
Chills (4),
Pneumonia (4),
Lymphadenopathy (3),
Pruritus (3),
Abdominal Pain Upper (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Arzerra (Ofatumumab). For a complete list or a specific selection of reports, please use the links above.
Possible Arzerra side effects in female
Reported by a physician from Italy on 2012-08-27
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Vomiting, Hypotension, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Dosage: 300mg cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-20
Cyclophosphamide
Dosage: 600mgm2 cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-19
Losazid
Dosage: 50mg twice per day
Administration route: Oral
Indication: Hypertension
Start date: 2009-03-29
End date: 2012-07-25
Nipent
Dosage: 2mgm2 cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-19
Other drugs received by patient: Allopurinol; Sulfamethoxazole and Trimethoprim
Possible Arzerra side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Neutropenia, Thrombocytopenia
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Hypertension, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 61 year old male, weighing 122.3 kg (269.1 pounds)
Reactions: White Blood Cell Count Increased, Disease Progression
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Acetaminophen; Methylprednisolone Sodium Succinate; Glucosamine Sulfate; Multi-Vitamin; Lantus; Aspirin; Lisinopril; Atenolol; Calcium; Ascorbic Acid; Vitamin D; Diphenhydramine HCL; Januvia; Glipizide; Xanax; MSM + Glucosamine
Possible Arzerra side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 63 year old male
Reactions: Urticaria
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Dexamethasone; Diphenhydramine Hydrochloride; Cetirizine; Acetaminophen
Possible Arzerra side effects in 86 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 86 year old female, weighing 69.1 kg (152.0 pounds)
Reactions: Dyspnoea, Hypertension, Oxygen Saturation Decreased, Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Diphenhydramine Hydrochloride; Acetaminophen; Procrit; Solu-Cortef
Possible Arzerra side effects in male
Reported by a physician from United Kingdom on 2012-08-16
Patient: male, weighing 62.4 kg (137.3 pounds)
Reactions: Febrile Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-05-31
Bendamustine Hydrochloride
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-05-31
Prednisolone
Dosage: 20mg as required
Administration route: Oral
Start date: 2012-05-31
Other drugs received by patient: Metoclopramide; Chlorpheniramine Maleate; Allopurinol; Acyclovir; Acetaminophen; Neupogen
Possible Arzerra side effects in 50 year old male
Reported by a physician from Finland on 2012-08-16
Patient: 50 year old male
Reactions: Death, Neuropathy Peripheral
Adverse event resulted in: death
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in female
Reported by a physician from Japan on 2012-08-16
Patient: female, weighing 54.5 kg (119.9 pounds)
Reactions: Erythema Multiforme
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 74 year old female
Reported by a physician from United States on 2012-08-16
Patient: 74 year old female, weighing 75.9 kg (167.0 pounds)
Reactions: Blood Culture Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Dosage: 2000mg cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-06-19
Campath
Dosage: 30mg weekly
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-06-05
Other drugs received by patient: Mirtazapine; Esomeprazole Magnesium; Humalog; Prochlorperazine; Alprazolam; Fluconazole; Rosuvastatin; Ramipril; Pentamidine Isethionate; Estradiol; Nepafenac; Ferrous Sulfate TAB; Pred Forte; Lantus; Acyclovir; Cyanocobalamin + Folic Acid + Pyridoxine Hydrochloride; Vesicare
Possible Arzerra side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-27
Patient: female
Reactions: Neutropenia, Treatment Noncompliance, Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 86 year old female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 86 year old female
Reactions: Dyspnoea, Hypertension, Oxygen Saturation Decreased, Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Solu-Cortef; Diphenhydramine HCL; Procrit; Acetaminophen
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11
Patient: male
Reactions: Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Unknown
Possible Arzerra side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11
Patient:
Reactions: Product Quality Issue, Anaphylactic Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Unknown
Possible Arzerra side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09
Patient: female
Reactions: Neck Pain, Abasia, Oropharyngeal Pain, Infusion Related Reaction
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Revlimid
Possible Arzerra side effects in 41 year old female
Reported by a physician from Spain on 2012-06-27
Patient: 41 year old female
Reactions: Bronchospasm, Rash, Laryngeal Oedema
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Acetylsalicylic Acid SRT; Montelukast
Possible Arzerra side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-06-27
Patient: 75 year old male
Reactions: White Blood Cell Count Decreased, Cardiac Failure, Haemorrhage, Platelet Count Decreased, Acute Respiratory Distress Syndrome, Pyrexia, Neutrophil Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in
Reported by a pharmacist from United States on 2012-06-22
Patient:
Reactions: Neutropenia
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-06-19
Patient: 75 year old male
Reactions: White Blood Cell Count Decreased, Haemorrhage, Platelet Count Decreased, Pyrexia, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 86 year old male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: 86 year old male
Reactions: Myalgia, Muscular Weakness, Hypoaesthesia, Progressive Multifocal Leukoencephalopathy, Neurological Symptom, Renal Failure Acute
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-06-12
Patient: male
Reactions: White Blood Cell Count Decreased, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient:
Reactions: Diarrhoea, Pyrexia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: 63 year old female, weighing 93.6 kg (205.9 pounds)
Reactions: Diarrhoea, Mental Status Changes, Gait Disturbance, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Venlafaxine; Atenolol; Loperamide; Mepron; Zomig; Compazine; Levaquin; Azithromycin
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: male
Reactions: Dyspnoea, Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in female
Reported by a pharmacist from United States on 2012-05-24
Patient: female
Reactions: Infusion Related Reaction
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: male
Reactions: Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: male
Reactions: Neutropenia
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: male
Reactions: Abdominal Discomfort
Drug(s) suspected as cause:
Arzerra
Possible Arzerra side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: 75 year old female, weighing 72.5 kg (159.5 pounds)
Reactions: Throat Tightness
Drug(s) suspected as cause:
Arzerra
Other drugs received by patient: Diphenhydramine HCL
|
