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

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Lung Disorder, Decreased Immune Responsiveness, Infection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Diovan; Warfarin Sodium; Avonex; Metoprolol Tartrate; Crestor



Possible Remicade side effects in male

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

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Pleurisy, Endocarditis

Drug(s) suspected as cause:
Remicade
    Start date: 2008-05-21

Remicade
    Start date: 2008-05-21

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-24

Remicade
    Indication: Tendonitis
    Start date: 2012-05-24

Other drugs received by patient: Ativan; Prevacid; Ativan; Elavil; Celebrex



Possible Remicade side effects in female

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

Patient: female, weighing 52.7 kg (115.9 pounds)

Reactions: Maternal Exposure During Pregnancy, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-04-03
    End date: 2012-04-10

Remicade



Possible Remicade side effects in female

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

Patient: female, weighing 71.0 kg (156.2 pounds)

Reactions: Skin Discolouration, Pain, Oedema Peripheral, Mobility Decreased

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Prednisone TAB; Calcium; Actonel



Possible Remicade side effects in male

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

Patient: male, weighing 108.9 kg (239.5 pounds)

Reactions: Nail Operation

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Methotrexate



Possible Remicade side effects in 76 year old male

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

Patient: 76 year old male, weighing 87.0 kg (191.4 pounds)

Reactions: Chest Pain, Drug Interaction, Clostridium Difficile Colitis, Depression, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2009-08-25

Remicade
    Indication: Psoriasis
    Start date: 2009-07-14

Remicade
    Start date: 2009-07-29

Remicade
    Start date: 2009-10-20

Other drugs received by patient possibly interacting with the suspect drug:
Fentanyl
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Atarax; Tilidin; Psorcutan Beta



Possible Remicade side effects in 53 year old male

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

Patient: 53 year old male

Reactions: Aesthesioneuroblastoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Ankylosing Spondylitis
    Start date: 2005-11-01
    End date: 2006-05-01

Humira
    Dosage: 40 mg, every other week
    Indication: Ankylosing Spondylitis
    Start date: 2006-10-01
    End date: 2011-02-18

Remicade
    Dosage: 3 mg/kg, single
    Indication: Ankylosing Spondylitis
    Start date: 2011-03-23
    End date: 2011-04-07



Possible Remicade side effects in female

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

Patient: female, weighing 127.0 kg (279.4 pounds)

Reactions: Nephrolithiasis

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Metformin HCL



Possible Remicade side effects in 31 year old female

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

Patient: 31 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Disseminated Intravascular Coagulation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Vitamin D; Vitamine B12; Iron Therapy; Methylprednisolone



Possible Remicade side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Premature Labour

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

Prednisolone
    Dosage: 30-40 mg
    Indication: Crohn's Disease
    Start date: 2008-01-01

Remicade
    Dosage: dose: 7.5mg/kg
    Indication: Crohn's Disease
    Start date: 2008-01-01



Possible Remicade side effects in 27 year old female

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

Patient: 27 year old female

Reactions: Respiratory Disorder, Body Temperature Increased, Chills, Maternal Exposure During Pregnancy, Rash, Infusion Related Reaction

Drug(s) suspected as cause:
Remicade
    Start date: 2012-07-09

Remicade
    Start date: 2011-03-01
    End date: 2011-10-25

Remicade
    Start date: 2012-07-17
    End date: 2012-07-17

Remicade
    Indication: Ankylosing Spondylitis
    Start date: 2012-06-25

Other drugs received by patient: Polaramine; Polaramine



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 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 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 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 64.0 kg (140.8 pounds)

Reactions: Leukaemia

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 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

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

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