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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 31 year old male

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

Patient: 31 year old male

Reactions: Chronic Lymphocytic Leukaemia

Drug(s) suspected as cause:
Remicade



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: Wound Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Folic Acid; Multi-Vitamins; Cholecalciferol; Cimzia; Calcium Carbonate Vitamin D; Ferrous Sulfate TAB



Possible Remicade side effects in male

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

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Blood Pressure Increased, Syncope, Asthenia, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Solu-Cortef; Altace; Tylenol; Metoprolol Tartrate; Plavix



Possible Remicade side effects in male

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

Patient: male, weighing 65.8 kg (144.7 pounds)

Reactions: Abdominal Pain, Colitis Ulcerative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Prednisone TAB; Clomipramine HCL



Possible Remicade side effects in 54 year old female

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

Patient: 54 year old female

Reactions: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Rheumatoid Arthritis



Possible Remicade side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Lymphoma

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 39.5 kg (86.9 pounds)

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Famotidine; Metamucil-2; Iron; Multiple Vitamin; Adalimumab; Oxycodone HCL; Calcium Citrate



Possible Remicade side effects in female

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

Patient: female, weighing 32.2 kg (70.8 pounds)

Reactions: Colitis Ulcerative

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Prednisone TAB; Methotrexate



Possible Remicade side effects in female

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

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Fractured Sacrum, Pleurisy, Stress Fracture

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Celebrex; Methotrexate



Possible Remicade side effects in female

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

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Laceration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in 26 year old male

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

Patient: 26 year old male

Reactions: Dizziness, Hyperhidrosis, Loss of Consciousness, Infusion Related Reaction

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-08-15

Remicade
    Start date: 2010-08-01

Other drugs received by patient: Hydrocortisone; Benadryl; Tylenol



Possible Remicade side effects in female

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

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Caesarean Section, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Imuran; Tridol; Morphine; Multi-Vitamins; Folic Acid



Possible Remicade side effects in female

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

Patient: female, weighing 99.8 kg (219.5 pounds)

Reactions: Weight Decreased, Malaise, Body Temperature Decreased

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 37.8 kg (83.2 pounds)

Reactions: Weight Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2012-08-18

Remicade
    Indication: Crohn's Disease
    Start date: 2010-01-01



Possible Remicade side effects in female

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

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Leukaemia

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in

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

Patient:

Reactions: Meningitis Aseptic

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 61.0 kg (134.2 pounds)

Reactions: Pyrexia, Joint Injury, Skeletal Injury

Drug(s) suspected as cause:
Remicade
    Dosage: 10th infusion
    Indication: Crohn's Disease
    Start date: 2012-07-09

Remicade
    Start date: 2011-06-18

Other drugs received by patient: Prevacid; Panthenol; Oxycontin; Gabapentin; Prednisone TAB



Possible Remicade side effects in male

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

Patient: male, weighing 59.4 kg (130.7 pounds)

Reactions: Incision Site Abscess, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2005-08-07
    End date: 2012-05-07

Remicade
    Start date: 2008-03-10

Remicade
    Indication: Crohn's Disease
    Start date: 2008-05-08

Remicade
    Start date: 2008-01-11

Other drugs received by patient: Multivitamin; Modafinil; Atenolol; Benadryl; Naltrexone Hydrochloride; Xopenex; Miralax; Immune Globulin Intravenous (Human); Creatine; Fludrocortisone Acetate; Pulmicort; Mesalamine; Selenium; Midodrine Hydrochloride; Coenzyme Q10; Nexium; Vitamin D; Gabapentin; Lipoic Acid; Ondansetron; Riboflavin CAP; Acetaminophen; E Vitamin; Magnesium Citrate; Calcium Carbonate; Ascorbic Acid; Folic Acid; Glycolax; Levocarnitine



Possible Remicade side effects in female

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

Patient: female, weighing 85.0 kg (187.0 pounds)

Reactions: Breast Cancer

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Leflunomide; Acetaminophen and Codeine Phosphate; Azulfidine; HRT; Diclofenac Sodium



Possible Remicade side effects in male

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

Patient: male, weighing 54.2 kg (119.2 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Azathioprine Sodium; Zinc Sulfate; Antibiotics; Vitamin D; Prednisone TAB; Iron



Possible Remicade side effects in female

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

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Weight Decreased, Psoriasis

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female

Reactions: Viral Infection, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Dosage: frequency: at 0, 2, 6 weeks. total dose: 200 mg
    Start date: 2012-05-17

Remicade
    Indication: Crohn's Disease
    Start date: 2012-06-27

Other drugs received by patient: Humira; Warfarin Sodium; Omeprazole; Potassium Citrate; Levoxyl; ALL Other Therapeutics; Vitamin B-12; Ferrous Sulfate TAB; Atenolol; Calcimate; Calcium and Vitamin D3; Vitamin D; Magnesium Oxide; Sodium Bicarbonate; Alendronate Sodium



Possible Remicade side effects in female

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

Patient: female, weighing 2.2 kg (4.9 pounds)

Reactions: Premature Baby

Drug(s) suspected as cause:
Pentasa
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Prednisone TAB
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Remicade

Remicade
    Start date: 2008-01-01

Remicade
    Indication: Foetal Exposure During Pregnancy



Possible Remicade side effects in male

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

Patient: male, weighing 70.3 kg (154.7 pounds)

Reactions: Pneumocystis Jiroveci Pneumonia, Colitis Ulcerative, Immune System Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asacol
    Indication: Colitis Ulcerative

Azathioprine Sodium
    Indication: Colitis Ulcerative
    End date: 2012-01-01

Prednisone TAB
    Indication: Colitis Ulcerative
    Start date: 2011-04-01

Remicade
    Indication: Colitis Ulcerative
    Start date: 2012-05-22
    End date: 2012-06-06

Other drugs received by patient: Acecol



Possible Remicade side effects in female

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

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Grand MAL Convulsion, Bone Pain, Oedema Peripheral, Headache, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fentanyl-100
    Indication: Pain
    Start date: 2010-01-01

Fentanyl-100
    Indication: Pain
    Start date: 2007-01-01

Fentanyl-100
    Start date: 2007-01-01

Remicade
    Indication: Crohn's Disease
    Start date: 2012-07-17

Remicade
    Start date: 2002-01-01
    End date: 2003-12-01

Other drugs received by patient: Prednisone TAB; Bentyl



Possible Remicade side effects in 28 year old female

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

Patient: 28 year old female

Reactions: Drug Effect Decreased, Arthralgia, Joint Swelling, Joint Stiffness

Drug(s) suspected as cause:
Remicade
    Start date: 2011-03-01

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

Remicade
    Dosage: 3rd infusion
    Start date: 2011-06-01
    End date: 2011-08-01

Remicade
    Start date: 2012-06-01



Possible Remicade side effects in female

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

Patient: female

Reactions: Back Pain, Monoclonal Gammopathy, Arthralgia

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in male

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

Patient: male, weighing 53.7 kg (118.1 pounds)

Reactions: Brain Stem Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-08

Remicade
    Indication: Crohn's Disease
    Start date: 2008-09-11

Other drugs received by patient: Calcichew D3; Sodium Chloride; Azathioprine Sodium



Possible Remicade side effects in female

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

Patient: female

Reactions: Smear Cervix Abnormal

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Fatigue, Dysstasia

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-05-25

Remicade
    Start date: 2012-08-20

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