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Rituxan (Rituximab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rituxan (Rituximab) 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 (582)
Death (193)
Life Threatening Events (29)
Disability (8)

Reports by Reaction Type

Death (115)Dyspnoea (37)Pyrexia (22)Pneumonia (22)Progressive Multifocal Leukoencephalopathy (20)Fatigue (18)Vomiting (18)Nausea (17)Diarrhoea (17)Rash (16)Neutropenia (16)Febrile Neutropenia (15)

Below are a few examples of reports where side effects / adverse reactions may be related to Rituxan (Rituximab). For a complete list or a specific selection of reports, please use the links above.

Possible Rituxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient: male

Reactions: Dyspnoea, NO Therapeutic Response, Oedema Peripheral, Erythema

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2012-02-06

Rituxan
    Indication: Rheumatoid Arthritis
    Start date: 2012-08-01

Rituxan
    Start date: 2012-08-15



Possible Rituxan side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 69 year old female

Reactions: Confusional State, Vertigo, Asthenia, Hallucination

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Blood Pressure Increased, Urinary Tract Infection, Tremor, Paraesthesia, Peripheral Nerve Infection, Arthralgia, Diarrhoea, Blood Pressure, Colitis, Knee Arthroplasty, Feeling Abnormal, Sinusitis

Drug(s) suspected as cause:
Rituxan
    Start date: 2012-03-06

Rituxan
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-03

Rituxan
    Start date: 2012-03-20

Other drugs received by patient: Gabapentin



Possible Rituxan side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in female

Reported by a physician from Canada on 2012-08-23

Patient: female, weighing 102.2 kg (224.7 pounds)

Reactions: Drug Intolerance, Headache, Infusion Related Reaction

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-27
    End date: 2012-01-27

Rituxan
    Indication: Rheumatoid Arthritis
    Start date: 2008-12-15

Rituxan

Other drugs received by patient: Atacand HCT; Nifedipine; Gliclazide; Acetaminophen; Methylprednisolone; Zofran; Januvia; Diphenhydramine HCL; Diamicron



Possible Rituxan side effects in 39 year old female

Reported by a pharmacist from United States on 2012-08-23

Patient: 39 year old female, weighing 82.6 kg (181.6 pounds)

Reactions: Dyspnoea, Vomiting, Chest Discomfort, Pruritus, Nausea, Rash, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituxan

Other drugs received by patient: Prednisone; Pyroxidine; Calcium; Folic Acid; Leucovorin Calcium; Methotrexate; Ibuprofen; Lisinopril; Diazepam; Fexofenadine; Pantoprazole; Acetaminophen; Diphenhydramine Hydrochloride; Multi-Vitamin



Possible Rituxan side effects in 18 year old female

Reported by a pharmacist from United States on 2012-08-23

Patient: 18 year old female

Reactions: Haemolytic Anaemia, Thrombotic Thrombocytopenic Purpura

Drug(s) suspected as cause:
Rituxan

Other drugs received by patient: Cyclophosphamide



Possible Rituxan side effects in female

Reported by a physician from United Kingdom on 2012-08-22

Patient: female

Reactions: Swelling Face, Joint Swelling, Insomnia, Rash Pruritic, Joint Stiffness

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-22

Patient: 81 year old male

Reactions: Vision Blurred, Neutropenia, Thrombocytopenia, Fall, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in female

Reported by a physician from United Kingdom on 2012-08-22

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Squamous Cell Carcinoma

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in 32 year old female

Reported by a physician from Portugal on 2012-08-22

Patient: 32 year old female

Reactions: NO Therapeutic Response, Pregnancy

Drug(s) suspected as cause:
Mycophenolate Mofetil (Cellcept)
    Indication: Systemic Lupus Erythematosus

Rituxan
    Indication: Systemic Lupus Erythematosus



Possible Rituxan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female

Reactions: Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan
    Dosage: 375/m2, unk
    Indication: Idiopathic Thrombocytopenic Purpura

Rituxan
    Indication: Lupus-Like Syndrome

Rituxan

Other drugs received by patient: Prednisone TAB; Prednisone TAB; Panglobulin; Calcium Carbonate; Ergocalciferol; Zoledronic Acid; Iron Polysaccharide; Conjugated Estrogens; Imuran; Omeprazole; Sumatriptan; Mirtazapine; Ascorbic Acid; Sulfamethoxazole; Prednisone TAB; Romiplostim; Atenolol; Prednisone TAB; Danazol; Acetaminophen; Alprazolam



Possible Rituxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in male

Reported by a pharmacist from United States on 2012-08-20

Patient: male

Reactions: Tachycardia, Blood Pressure Decreased, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: female, weighing 70.4 kg (154.9 pounds)

Reactions: Movement Disorder, Dyspnoea, Local Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1280 mg

Doxorubicin Hydrochloride
    Dosage: 86 mg

Prednisone
    Dosage: 70 mg

Rituxan
    Dosage: 650 mg

Vincristine Sulfate
    Dosage: 2 mg



Possible Rituxan side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female

Reactions: Wheelchair User, Muscular Weakness

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Pruritus, Visual Impairment, Oral Disorder, Psoriasis, Gingival Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Lymphoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in 68 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-17

Patient: 68 year old male

Reactions: Hepatitis B

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Splenic Marginal Zone Lymphoma

Doxorubicin Hydrochloride
    Indication: Splenic Marginal Zone Lymphoma

Prednisone TAB
    Indication: Immunosuppression

Rituxan
    Indication: Splenic Marginal Zone Lymphoma

Vincristine
    Indication: Splenic Marginal Zone Lymphoma



Possible Rituxan side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male, weighing 84.7 kg (186.3 pounds)

Reactions: Splenic Vein Thrombosis, Venous Haemorrhage, Iatrogenic Injury, Splenic Neoplasm Malignancy Unspecified, Platelet Count Decreased, Gastric Varices, Haemorrhagic Ascites, Venous Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1520 mg

Doxorubicin Hydrochloride
    Dosage: 101 mg

Prednisone TAB
    Dosage: 400 mg

Rituxan
    Dosage: 758 mg

Vincristine Sulfate
    Dosage: 2 mg



Possible Rituxan side effects in

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient:

Reactions: Weight Decreased, Unwanted Awareness During Anaesthesia, Dyspnoea, Lower Limb Fracture, Paraesthesia, Tremor, Irritability, Fatigue, Balance Disorder, Dizziness, Ulcer Haemorrhage, Papilloma Viral Infection, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituxan
    Indication: non-Hodgkin's Lymphoma
    Start date: 2005-01-01

Rituxan
    Dosage: late dec/2011 or jan/2012



Possible Rituxan side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male, weighing 84.7 kg (186.3 pounds)

Reactions: Splenic Vein Thrombosis, Abdominal Distension, Haemorrhagic Ascites, Venous Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1520 mg

Doxorubicin Hydrochloride
    Dosage: 101 mg

Prednisone
    Dosage: 400 mg

Rituxan
    Dosage: 758 mg

Vincristine Sulfate
    Dosage: 2 mg



Possible Rituxan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Thrombosis, RED Blood Cell Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Procrit
    Indication: Product Used FOR Unknown Indication

Rituxan
    Indication: Rheumatoid Arthritis



Possible Rituxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: male, weighing 91.7 kg (201.7 pounds)

Reactions: Pneumonia, Anaemia, Pancytopenia, Febrile Neutropenia, Respiratory Failure, Muscle Abscess, Thrombocytopenia, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Rituxan
    Dosage: 150 milligram
    Start date: 2012-05-14

Rituxan
    Start date: 2012-06-22

Rituxan
    Start date: 2012-07-19
    End date: 2012-07-20

Rituxan
    Dosage: 17.8571 milligram
    Start date: 2012-08-04

Vidaza
    Dosage: 150 milligram
    Start date: 2012-05-14

Vidaza
    Dosage: 150 milligram
    Start date: 2012-07-19
    End date: 2012-07-20

Other drugs received by patient: Procrit; Fluticasone Propionate; Folic Acid; Hydrocortisone-Pramoxine; Metoprolol Tartrate; Rosuvastatin; Meropenem; Vancomycin; Dextrose; Acetaminophen; Calcium + Vitamin D; Ciprofloxacin-Dexamethasone Otic; Diphenhydramine Hydrochloride; Filgrastim; Multi-Vitamins; Phenylephrine Hydrochloride; Acetaminophen; Naproxen; Whole Blood; Prednisone TAB; Vitamin B-12; Acetaminophen; Benazepril Hydrochloride; Augmentin '500'; Amlodipine; Omeprazole; Sodium Chloride



Possible Rituxan side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male

Reactions: Aphasia, Unevaluable Event, Hemiparesis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in

Reported by a physician from China on 2012-08-14

Patient:

Reactions: Dyspnoea, Hyperpyrexia, Tachycardia, Oliguria, Altered State of Consciousness, Hypertension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Maternal Exposure Timing Unspecified, Lymphocyte Count Decreased

Drug(s) suspected as cause:
Rituxan



Possible Rituxan side effects in male

Reported by a pharmacist from United States on 2012-08-10

Patient: male

Reactions: Nausea, Chest Pain

Drug(s) suspected as cause:
Rituxan

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