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Actemra (Tocilizumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Actemra (Tocilizumab) 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 (2507)
Death (394)
Life Threatening Events (178)
Disability (48)

Reports by Reaction Type

Pneumonia (118)Death (106)Arthralgia (95)Sepsis (71)Interstitial Lung Disease (67)Drug Ineffective (63)Pain (63)Pyrexia (60)Fall (57)Pain in Extremity (56)Malaise (55)Headache (54)

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

Possible Actemra side effects in female

Reported by a physician from Brazil on 2012-08-27

Patient: female

Reactions: Retinal Injury

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Methotrexate



Possible Actemra side effects in male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-27

Patient: male

Reactions: Tonsillitis, Neutrophil Count Decreased

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Insulin



Possible Actemra side effects in 14 year old male

Reported by a physician from France on 2012-08-27

Patient: 14 year old male

Reactions: Histiocytosis Haematophagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in 47 year old female

Reported by a physician from Colombia on 2012-08-27

Patient: 47 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Actemra
    Dosage: date of last dose prior to sae : 13/jun/2012
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-07

Actemra
    Dosage: date of most recent dose prior to sae:22/feb/2012
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-21

Other drugs received by patient: Chloroquine; Prednisolone; Omeprazole; Methotrexate; Diclofenac Sodium; Naproxen; Folic Acid; Acetaminophen



Possible Actemra 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 Actemra side effects in 78 year old female

Reported by a physician from Japan on 2012-08-25

Patient: 78 year old female

Reactions: Streptococcal Bacteraemia, Pneumonia Streptococcal, Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in male

Reported by a physician from Japan on 2012-08-25

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Dermatitis Allergic, Pruritus, Erythema, Fall, Death, Arthralgia, Injury, White Blood Cell Count Increased, Infection

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Prednisolone; Precipitated Calcium Carbonate; Levothyroxine Sodium; Allegra; Lasix; Sulfamethoxazole and Trimethoprim; Micardis; Vildagliptin; Bisoprolol Fumarate



Possible Actemra side effects in male

Reported by a physician from Japan on 2012-08-25

Patient: male

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Start date: 2011-04-25

Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2009-03-13
    End date: 2010-10-29

Other drugs received by patient: Loxonin; Loxonin; Folic Acid; Mucosta; Mucosta; Rheumatrex



Possible Actemra side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-24

Patient: male, weighing 98.5 kg (216.7 pounds)

Reactions: Thrombosis, Pneumonia, Dyspnoea, Cellulitis, Nasopharyngitis, Pyrexia, Rash, Fall, Cardiac Disorder, Muscle Strain, Rheumatoid Arthritis, Oedema Peripheral, Pleural Effusion, RED Blood Cell Sedimentation Rate Increased, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra

Actemra
    Dosage: last infusion: 28/jun/2012
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Insulin; Magnesium; Spironolactone; Digoxin; Bisoprolol Fumarate; Vitamin E; Lipitor; Folic Acid; Rabeprazole Sodium; Vitamin D; Prednisone TAB; Furosemide; Aspirin; Alendronate Sodium; Selenium; Calcium; Ramipril; Citalopram Hydrobromide



Possible Actemra side effects in female

Reported by a physician from South Africa on 2012-08-24

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Aortic Stenosis, Peripheral Vascular Disorder, Aortic Arteriosclerosis, Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Dosage: last dose prior to sae:26/apr/2012
    Indication: Rheumatoid Arthritis
    Start date: 2011-03-04
    End date: 2012-05-25

Placebo
    Dosage: last dose prir to sae on 18/may/2012
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-03-04
    End date: 2012-05-25

Other drugs received by patient: Cholecalciferol; Stopayne; Prednisone TAB; Simvastatin; Fluoxetine HCL; Prednisolone; Nuzak; Crestor; Simvastatin; Stilpane Tablets; Brazepam; Folic Acid; Celebrex; Cefazolin; Potassium Chloride; Ativan; Dormicum (South Africa); Amitriptyline HCL; Aspirin; Aspirin; Dantron; Lasix; Slow-K; Picoprep; Levothyroxine Sodium; Crestor; Erythromycin; Tramadol Hydrochloride / Acetaminophen; Voltaren; Andolex C Spray; Nuzak; Tramadol Hydrochloride; Dormonoct; Aspirin; Acetaminophen; Enoxaparin Sodium; Pantocid; Calciferol



Possible Actemra side effects in female

Reported by a physician from Japan on 2012-08-24

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Encephalitis, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Famotidine; Prednisolone; Celebrex; Prograf; Olmesartan Medoxomil; Persantine; Procylin



Possible Actemra side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: female

Reactions: Ill-Defined Disorder

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in female

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

Patient: female, weighing 39.5 kg (86.9 pounds)

Reactions: Blister

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: female, weighing 130.0 kg (286.0 pounds)

Reactions: White Blood Cell Count Decreased, Haemoglobin Decreased, Platelet Count Decreased, Nasal Congestion, Haemorrhoidal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2012-06-10

Actemra
    Start date: 2010-06-10

Other drugs received by patient: Actonel; Tylenol W / Codeine NO. 3; Ascorbic Acid; Amitriptyline Hydrochloride; Hydrochlorothiazide; Vitamin E; Prednisone TAB; Sulfasalazine; Percocet; Primrose



Possible Actemra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Abdominal Pain, Diarrhoea, Nausea, Abdominal Distension

Drug(s) suspected as cause:
Actemra
    Start date: 2012-06-26
    End date: 2012-07-17

Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-05

Actemra
    Start date: 2012-05-24

Actemra
    Start date: 2012-04-26

Other drugs received by patient: Ranitidine; Prednisone TAB; Aspirin; Alendronate Sodium; Cholecalciferol; Methotrexate; Polyethylene Glycol; Cyanocobalamin; Prednisone TAB; Omeprazole; Omega 3 Fatty Acids; Folic Acid; Sertraline Hydrochloride; Ubiquinone; Senna / Docusate Sodium



Possible Actemra side effects in male

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

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Stomatitis, Henoch-Schonlein Purpura, Arthralgia, Pain in Extremity, Tonsillitis, Rash, Jejunitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Start date: 2012-03-19
    End date: 2012-03-19

Actemra
    Dosage: dosage is uncertain.
    Indication: Juvenile Arthritis
    Start date: 2012-01-04
    End date: 2012-01-04

Other drugs received by patient: Rheumatrex; Rheumatrex; Rheumatrex; Rheumatrex



Possible Actemra side effects in female

Reported by a health professional (non-physician/pharmacist) from South Africa on 2012-08-23

Patient: female, weighing 92.0 kg (202.4 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Methotrexate; Atorvastatin Calcium; Folic Acid; Prednisone TAB; Coxflam



Possible Actemra 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 Actemra side effects in male

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

Patient: male, weighing 83.0 kg (182.6 pounds)

Reactions: Bronchitis, Cystitis, Hypochromic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2009-12-04
    End date: 2010-03-01

Leflunomide
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2007-03-01
    End date: 2010-03-01

Roactemra
    Start date: 2010-04-21
    End date: 2010-04-21

Other drugs received by patient: Methotrexate Sodium; Atorva; Prednisolone; Celebrex; Tamsulosin HCL



Possible Actemra side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-23

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Contusion, Hiatus Hernia, Platelet Count Decreased, Cholecystectomy, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-03-15

Roactemra
    Dosage: last dose of administration: 10/aug/2012
    Start date: 2012-06-15

Other drugs received by patient: Voltaren; Vitamin B-12; Ascorbic Acid; Minocycline HCL; Zopiclone; Lorazepam; Echinacea; Morphine; Fluticasone Propionate; Synthroid; Prednisone TAB



Possible Actemra side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: female

Reactions: Renal Impairment

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Zoloft; Levothyroxine Sodium



Possible Actemra side effects in female

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

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: White Blood Cell Count Decreased, Anaemia, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-07-11
    End date: 2011-01-01

Actemra
    Start date: 2011-01-01

Rheumatrex
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    End date: 2011-07-16

Other drugs received by patient: Prednisolone; Prednisolone; Prednisolone; Prednisolone; Levothyroxine Sodium; Risedronate Sodium; Urso 250



Possible Actemra side effects in 49 year old male

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

Patient: 49 year old male

Reactions: Anaemia, Small Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in female

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

Patient: female, weighing 67.5 kg (148.5 pounds)

Reactions: Small Intestinal Obstruction, Abdominal Adhesions

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Actemra
    Dosage: wk 52 only
    Indication: Rheumatoid Arthritis

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-06-30

Placebo
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Alendronate Sodium; Symbicort; Prednisolone; Tiotropium; Lansoprazole; Prednisolone; Celecoxib; Albuterol Sulate; Theophylline; Simvastatin



Possible Actemra side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-22

Patient: female, weighing 95.3 kg (209.7 pounds)

Reactions: Pruritus, Swelling Face, Dysphagia, Urticaria, Adverse Drug Reaction, Headache, Erythema, Cardiac Disorder, Loss of Consciousness, Fatigue, Feeling Hot, Eye Movement Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Prednisone TAB; Actonel; Folic Acid; Crestor; Oxycet; Olmesartan Medoxomil



Possible Actemra side effects in 47 year old female

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

Patient: 47 year old female, weighing 36.5 kg (80.3 pounds)

Reactions: Weight Decreased, Psychotic Disorder, Drug Ineffective, Nervous System Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Dosage: unk

Enbrel
    Dosage: 50 mg, once weekly
    Indication: Rheumatoid Arthritis
    Start date: 2007-12-01
    End date: 2011-08-01

Other drugs received by patient: Risperidone; Clonazepam; Risperidone; Clonazepam; Corticosteroids; Clometacin; Methotrexate; Methotrexate



Possible Actemra side effects in female

Reported by a physician from Germany on 2012-08-21

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Skin Ulcer, Haematoma Infection, Skin Infection, Fall

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2010-04-26
    End date: 2011-02-08

Actemra

Other drugs received by patient: Pantoprazole; Diclofenac; Prednisolone; Lisinopril



Possible Actemra side effects in female

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

Patient: female, weighing 72.6 kg (159.8 pounds)

Reactions: Osteoarthritis, Pain in Extremity

Drug(s) suspected as cause:
Actemra

Other drugs received by patient: Arava; Folic Acid; Perindopril Erbumine



Possible Actemra side effects in female

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

Patient: female

Reactions: Confusional State, Weight Decreased, Aphasia, Paralysis, Fall, Cerebrovascular Accident, Amnesia, Convulsion, Blood Cholesterol Increased, Nervous System Disorder, Gait Disturbance, Microangiopathy, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra



Possible Actemra side effects in female

Reported by a health professional (non-physician/pharmacist) from South Africa on 2012-08-20

Patient: female

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Actemra

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