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Simponi (Golimumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Simponi (Golimumab) 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 (1268)
Death (54)
Life Threatening Events (37)
Disability (15)

Reports by Reaction Type

Pneumonia (104)Drug Dose Omission (103)Device Malfunction (71)Drug Ineffective (47)Infection (39)Hypertension (35)Headache (34)Rheumatoid Arthritis (33)Malaise (31)Device Failure (31)Pain in Extremity (29)Arthralgia (29)

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

Possible Simponi side effects in female

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

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Simponi
    Indication: Ankylosing Spondylitis
    End date: 2012-05-14

Simponi
    Start date: 2011-10-14

Other drugs received by patient: Zofran; Feldene; Tramadol HCL; Deltacortril; Omeprazole (Prisolec); Calcium Carbonate; Zimovane; Sertraline Hydrochloride



Possible Simponi side effects in female

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

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Pneumonia, Pneumonia Aspiration, Malnutrition, Atrial Fibrillation, Fall, Arrhythmia, Sepsis, Endocarditis, Pneumothorax, Cardiac Failure Congestive

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Simponi
    Start date: 2012-02-22

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-16

Simponi
    End date: 2012-06-29

Simponi
    Start date: 2012-06-15

Simponi
    Start date: 2012-03-21

Simponi
    Start date: 2012-04-18

Other drugs received by patient: Methotrexate; Bredinin; Lansoprazole; Verapamil HCL; Furosemide; Heparin Sodium; Seishoku; Celebrex; Propofol; Seishoku; Digoxin; Clindamycin; BIO-Three; Prednisolone; Warfarin; Furosemide; Diltiazem Hydrochloride; Seishoku; Potassium Chloride; Ceftazidime Sodium; Rebamipide; Prednisolone; Propofol; Mannitol; Isotonic Sodium Chloride Solution; Albumin (Human); Lasix; Slow-K; Furosemide; Bisoprolol Fumarate; Verapamil HCL; Loxonin; Glucose; Prednisolone; Isotonic Sodium Chloride Solution; Verapamil HCL; Omegacin; Sucralfate; Pantosin; Levemir; Unknown Medication; Acetated Ringer; Seishoku; Omeprazole; Isotonic Sodium Chloride Solution; Isotonic Sodium Chloride Solution; Isotonic Sodium Chloride Solution; Albumin (Human); Potassium Chloride; Verapamil HCL; Omegacin; Levofloxacin; Rhythmy; Glucose; Glucose; Glucose; Fulcaliq 1; Propofol; Clindamycin; Lasix; Fulcaliq 2; Elaspol; Glucose; Meropenem; Solu-Medrol; Solulact; Isotonic Sodium Chloride Solution; Omegacin



Possible Simponi side effects in female

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

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Sepsis, Circulatory Collapse, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in 76 year old female

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

Patient: 76 year old female

Reactions: Arthritis Bacterial

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Prednisolone



Possible Simponi side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi
    Start date: 2012-07-02

Simponi
    Start date: 2012-05-07

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-06-04

Other drugs received by patient: Etodolac



Possible Simponi side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: male

Reactions: Arthralgia, Headache, Tremor

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Cymbalta; Tylenol; Methotrexate; Celebrex



Possible Simponi side effects in female

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

Patient: female

Reactions: Oral Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leflunomide
    Indication: Product Used FOR Unknown Indication
    Start date: 1990-01-01

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2010-09-01
    End date: 2011-11-01

Other drugs received by patient: Tramadol HCL; Etanercept; Colecalciferol; Simvastatin; Pantoprazole; Metamizol; Prednisolone



Possible Simponi side effects in female

Reported by a consumer/non-health professional from Ireland on 2012-08-27

Patient: female

Reactions: Colitis

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Nebivolol HCL; Pantoprazole; Ramipril; Acetaminophen W / Codeine



Possible Simponi side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Dyspnoea, Visual Field Defect, Visual Impairment, Respiratory Arrest, Muscle Spasms

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male, weighing 88.8 kg (195.4 pounds)

Reactions: Pneumonia, Acute Respiratory Distress Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Simponi
    Indication: Psoriatic Arthropathy
    Start date: 2012-05-05

Simponi
    Start date: 2012-06-05



Possible Simponi side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 98.0 kg (215.6 pounds)

Reactions: Migraine, Asthma, Hypersensitivity, Haemorrhage, Abdominal Pain Upper, Anxiety, Rhinitis Allergic, Oedema Peripheral, Swelling

Drug(s) suspected as cause:
Simponi
    Start date: 2012-04-23
    End date: 2012-04-23

Simponi
    Indication: Psoriatic Arthropathy
    Start date: 2012-04-23
    End date: 2012-04-23

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-04-15

Simponi
    Start date: 2012-04-15

Other drugs received by patient: Spironolactone; Methotrexate; Proair HFA; Methotrexate; Levothyroxine Sodium; Ambien; Hydrochlorothiazide; Diprolene; Folic Acid; Ibuprofen; Clonazepam



Possible Simponi side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Adverse Drug Reaction

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

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

Patient: female

Reactions: Pancreatitis Acute, Bile Duct Stone

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Losartan Potassium and Hydrochlorothiazide; Prednisolone; Lipitor; Sulfasalazine; Atelec; Cholebrine; Methotrexate; Rabeprazole Sodium; Prednisolone; Aspirin; Viviant



Possible Simponi side effects in male

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

Patient: male

Reactions: Hepatomegaly, Campylobacter Infection, Cholecystectomy, Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Prednisone TAB; Methotrexate; Methotrexate



Possible Simponi side effects in female

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

Patient: female

Reactions: Escherichia Urinary Tract Infection, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Indication: Rheumatoid Arthritis

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-01

Other drugs received by patient: Amitriptyline HCL; Atacand; Dipyrone TAB; Torsemide



Possible Simponi side effects in female

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

Patient: female

Reactions: Thrombosis, Limb Operation, Cellulitis, Pulmonary Embolism, Mycobacterium Marinum Infection, Neoplasm, Herpes Zoster, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Aciphex; Magnesium; Pamelor; Vitamin B-12; Coumadin; Librax; Ultram



Possible Simponi side effects in female

Reported by a pharmacist from United States on 2012-08-24

Patient: female

Reactions: Fatigue, Nausea, Headache

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in male

Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-08-23

Patient: male

Reactions: Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi
    Start date: 2012-08-03

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-07-06



Possible Simponi side effects in female

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

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Malaise, Lung Disorder, Chest Pain, Cough

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Vitamin; Calcium; Folic Acid



Possible Simponi side effects in female

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

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Pneumothorax, Fall, Arrhythmia

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-02-22

Simponi
    End date: 2012-06-29

Simponi
    Start date: 2012-03-21

Simponi
    Start date: 2012-04-18

Other drugs received by patient: Levofloxacin; Celebrex; Rebamipide; Glucose; Albumin (Human); Ceftazidime Sodium; Bredinin; Prednisolone; Bisoprolol Fumarate; Verapamil HCL; Verapamil HCL; Levemir; Glucose; Propofol; Solulact; Clindamycin; Omegacin; Methotrexate; Warfarin Sodium; Glucose; Diltiazem Hydrochloride; Acetated Ringer; Seishoku; Albumin (Human); Potassium Chloride; Lasix; Lasix; Isotonic Sodium Chloride Solution; Potassium Chloride; Sucralfate; Slow-K; Lansoprazole; Pantosin; Elaspol; Glucose; Fulcaliq 1; Furosemide; Propofol; Mannitol; Seishoku; Seishoku; Isotonic Sodium Chloride Solution; Verapamil HCL; Omegacin; Furosemide; Meropenem; Solu-Medrol; Seishoku; Omeprazole; Isotonic Sodium Chloride Solution; Isotonic Sodium Chloride Solution; Isotonic Sodium Chloride Solution; Digoxin; Clindamycin; Fulcaliq 2; Rhythmy; Prednisolone; Propofol; Heparin Sodium; Isotonic Sodium Chloride Solution; BIO-Three; Furosemide; Loxonin; Unknown Medication; Glucose; Prednisolone; Verapamil HCL; Omegacin



Possible Simponi side effects in 60 year old male

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

Patient: 60 year old male

Reactions: Alveolitis Allergic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

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

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Skin Ulcer, Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rimatil
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-06

Simponi
    Start date: 2011-11-11
    End date: 2012-02-09

Other drugs received by patient: Levothyroxine Sodium; Etodolac; Bonoteo; Lansoprazole; Edirol; Vitamin B12



Possible Simponi side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Subdural Haematoma

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

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

Patient: female

Reactions: Tumour Marker Increased

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

Simponi
    Indication: Product Used FOR Unknown Indication



Possible Simponi side effects in female

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

Patient: female, weighing 51.3 kg (112.9 pounds)

Reactions: Hypersensitivity, Chest Discomfort, Fatigue, Dyspnoea, Pharyngeal Oedema, Respiratory Failure

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Folic Acid; Methotrexate; Estrace; Meloxicam



Possible Simponi side effects in 57 year old male

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

Patient: 57 year old male

Reactions: Diabetes Mellitus, Hypertension, Small Cell Lung Cancer Stage Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Methotrexate



Possible Simponi side effects in female

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

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Body Height Decreased, Emphysema, Abnormal Loss of Weight, Pulmonary Mass, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Verapamil; Methotrexate; Folic Acid; Prednisone TAB; Nitroglycerin



Possible Simponi side effects in female

Reported by a pharmacist from United States on 2012-08-21

Patient: female

Reactions: Tooth Fracture

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

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

Patient: female, weighing 58.1 kg (127.7 pounds)

Reactions: Asthma, Drug Dose Omission, Bronchopneumonia, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21

Patient: male

Reactions: Diarrhoea, Dizziness, Endocrine Neoplasm

Drug(s) suspected as cause:
Simponi

Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-17

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