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Remicade (Infliximab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Remicade (Infliximab) 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 (13744)
Death (600)
Life Threatening Events (465)
Disability (235)

Reports by Reaction Type

Infusion Related Reaction (1121)Crohn's Disease (639)Dyspnoea (576)Drug Ineffective (445)Skin Cancer (440)Arthralgia (391)Pneumonia (375)Pain (356)Herpes Zoster (344)Nausea (341)Diarrhoea (304)Vomiting (302)

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

Possible Remicade side effects in male

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

Patient: male

Reactions: Respiratory Disorder

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in male

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

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Facial Lesion Excision

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Acute Respiratory Distress Syndrome, Knee Arthroplasty, Bronchiolitis

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-08-06

Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 106.6 kg (234.5 pounds)

Reactions: Pruritus, Chest Discomfort, Hypersensitivity, Drug Ineffective, Diabetes Mellitus, Chills, Urticaria, Headache, Osteoarthritis, Vitamin D Decreased, Alopecia, Insomnia, Animal Scratch, Skin Atrophy

Drug(s) suspected as cause:
Cortisone Acetate
    Indication: Rheumatoid Arthritis

Enbrel
    Indication: Rheumatoid Arthritis

Prednisone TAB
    Indication: Rheumatoid Arthritis

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-07-01

Remicade
    Dosage: every 6 to 8 weeks
    Start date: 2003-01-01
    End date: 2006-01-01

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



Possible Remicade side effects in male

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

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Tubulointerstitial Nephritis, Renal Impairment

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade
    Indication: Behcet's Syndrome
    Start date: 2007-11-01

Remicade

Remicade
    Dosage: 18th dose
    Start date: 2012-05-01

Unknown Medication
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Adalat; Celectol; Prednisolone



Possible Remicade side effects in male

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

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Dystonia

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female

Reactions: Brain Neoplasm

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 51.2 kg (112.6 pounds)

Reactions: Weight Decreased, Nasopharyngitis, Mouth Ulceration, Pain, Psoriasis, Pallor, Dysphonia, Fungal Infection, Asthenia

Drug(s) suspected as cause:
Methotrexate

Methotrexate
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-15

Remicade
    Dosage: has had 20 inflixiamb infusions
    Start date: 2012-08-16

Remicade
    Dosage: has had 20 inflixiamb infusions
    Indication: Psoriatic Arthropathy
    Start date: 2009-06-17

Other drugs received by patient: Folic Acid; Pantoprazole Sodium



Possible Remicade side effects in female

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

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Renal Cancer, Tooth Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Cyproheptadine HCL; Adalat CC; Entocort EC; Vitamin B-12; Citalopram Hydrobromide; Hydromorphone Hydrochloride; Lomotil; Lenoltec NOS; Hydromorphone HCL; Ativan



Possible Remicade side effects in female

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

Patient: female, weighing 44.7 kg (98.3 pounds)

Reactions: Anal Fistula, Anal Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Crohn's Disease, Premature Labour

Drug(s) suspected as cause:
Pentasa
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Prednisolone
    Indication: Crohn's Disease
    Start date: 2008-01-01

Remicade
    Indication: Crohn's Disease

Remicade
    Dosage: 7.5mg/kg
    Start date: 2008-01-01

Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 26.6 kg (58.5 pounds)

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Remicade side effects in female

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

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Neoplasm Malignant, Crohn's Disease, Alanine Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2011-07-13

Remicade
    Start date: 2011-05-19

Remicade
    Start date: 2010-07-14

Remicade
    Start date: 2010-10-14

Remicade
    Start date: 2012-08-16

Remicade
    Start date: 2011-09-01

Remicade
    Start date: 2011-03-24

Remicade
    Start date: 2011-01-27

Remicade
    Start date: 2012-04-10

Remicade
    Start date: 2010-08-26

Remicade
    Start date: 2010-07-28

Remicade
    Indication: Crohn's Disease
    Start date: 2012-02-14

Remicade
    Start date: 2011-12-20

Remicade
    Start date: 2011-10-24

Remicade
    Start date: 2010-12-06

Other drugs received by patient: Cymbalta; Clonazepam; Mercaptopurine



Possible Remicade side effects in female

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

Patient: female

Reactions: Knee Operation, Pain, Atrophy

Drug(s) suspected as cause:
Remicade

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-07-17



Possible Remicade side effects in male

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

Patient: male

Reactions: Anxiety, Infusion Related Reaction

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Premedication; Antianxiety NOS; Benadryl



Possible Remicade side effects in male

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

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Nausea, Muscle Spasms

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Tylenol W / Codeine NO. 3



Possible Remicade side effects in male

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

Patient: male, weighing 66.0 kg (145.2 pounds)

Reactions: Cognitive Disorder, Meningitis Aseptic

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade
    Start date: 2009-09-09

Remicade
    Indication: Crohn's Disease
    Start date: 2009-12-21
    End date: 2010-09-23



Possible Remicade side effects in female

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

Patient: female, weighing 43.0 kg (94.6 pounds)

Reactions: Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Pentasa; Entocort EC



Possible Remicade side effects in male

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

Patient: male, weighing 62.1 kg (136.7 pounds)

Reactions: Large Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Calcium Carbonate; Atenolol; Miralax; Immune Globulin NOS; Nexium; Pulmicort; Xopenex; Coenzyme Q10; Tylenol; E Vitamin; Zofran; Selenium; Antibiotics; Benadryl; Provigil; Naltrexone Hydrochloride; Lipoic Acid; Mesalamine; Ascorbic Acid; Multi-Vitamins; Dulcolax; Riboflavin CAP; Neurontin



Possible Remicade side effects in male

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

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Death, Gastrointestinal Haemorrhage, Drug Ineffective

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female

Reactions: Myalgia, Musculoskeletal Stiffness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Hydrocortisone; ALL Other Therapeutic Products



Possible Remicade side effects in 34 year old male

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

Patient: 34 year old male

Reactions: Renal Cancer

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in male

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

Patient: male, weighing 56.8 kg (125.0 pounds)

Reactions: Peritonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Humira; Budesonide



Possible Remicade side effects in female

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

Patient: female, weighing 36.8 kg (81.0 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease

Remicade
    Start date: 2011-03-04

Other drugs received by patient: Antibiotics Unspecified



Possible Remicade side effects in male

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

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Weight Decreased

Drug(s) suspected as cause:
Remicade
    Start date: 2012-03-01

Remicade
    Indication: Crohn's Disease
    Start date: 2012-03-01

Other drugs received by patient: Prednisone TAB; Accolate



Possible Remicade side effects in 14 year old male

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

Patient: 14 year old male

Reactions: Lupus-Like Syndrome

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Intracranial Aneurysm

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2010-02-10

Remicade
    Start date: 2012-06-27

Other drugs received by patient: Methotrexate; Folic Acid; Actonel



Possible Remicade side effects in male

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

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Dermatitis Allergic, Movement Disorder, Back Pain, Dyspnoea, Paralysis, Muscular Weakness, Oropharyngeal Pain, Joint Swelling, Arthralgia, Sepsis, Oedema Peripheral, Dizziness, Heart Rate Irregular

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Dipyrone INJ; Multi-Vitamins; Mesalamine



Possible Remicade side effects in male

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

Patient: male, weighing 25.1 kg (55.2 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2012-05-22

Remicade
    Indication: Crohn's Disease

Other drugs received by patient: Folic Acid; Oxycodone HCL; Cefdinir; Multi-Vitamins; Ferrous Sulfate TAB; Hydrocortisone; Acetaminophen; Calcium Carbonate Vitamin D; Metronidazole; Methotrexate; Cholecalciferol



Possible Remicade side effects in female

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

Patient: female, weighing 105.0 kg (231.0 pounds)

Reactions: Joint Swelling, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

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