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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 United States on 2012-08-27

Patient: male, weighing 49.4 kg (108.8 pounds)

Reactions: Small Intestinal Obstruction, Perirectal Abscess, Pelvic Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2006-03-08

Remicade
    Indication: Inflammatory Bowel Disease
    Start date: 2008-01-22

Other drugs received by patient: Mesalamine; Bactrim; Iron; Prednisone TAB



Possible Remicade side effects in female

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

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Intestinal Operation

Adverse event resulted in: hospitalization

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 63.0 kg (138.6 pounds)

Reactions: Heat Rash, Cyst

Drug(s) suspected as cause:
Remicade
    Indication: Colitis Ulcerative
    Start date: 2008-11-01

Remicade
    Dosage: 24th infusion
    Start date: 2012-08-16



Possible Remicade side effects in male

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

Patient: male, weighing 80.9 kg (178.0 pounds)

Reactions: Subcutaneous Abscess, Dehydration, Hyponatraemia, Gastroenteritis Viral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-07-11

Remicade
    Start date: 2010-07-21

Other drugs received by patient: Iron; Calcium with Vitamin D; Multi-Vitamins



Possible Remicade side effects in male

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

Patient: male

Reactions: Thymoma Malignant

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in 13 year old male

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

Patient: 13 year old male

Reactions: Respiratory Disorder, Dyspnoea, Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-06-01

Remicade
    Start date: 2012-01-01

Other drugs received by patient: Benadryl; Acetaminophen; Steroids NOS



Possible Remicade side effects in female

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

Patient: female

Reactions: Renal Failure, Vasculitis

Adverse event resulted in: hospitalization

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 42.0 kg (92.4 pounds)

Reactions: Female Genital Tract Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Vitamin D; Azathioprine Sodium; Miralax; Antibiotics



Possible Remicade side effects in female

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

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Pancreatitis Acute, Small Intestinal Obstruction, Intestinal Fistula

Adverse event resulted in: hospitalization

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

Remicade
    Start date: 2012-01-18

Remicade
    Start date: 2012-02-07

Remicade
    Start date: 2012-01-03

Other drugs received by patient: Imuran; Imuran; Antibiotics FOR IBD



Possible Remicade side effects in 22 year old female

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

Patient: 22 year old female

Reactions: Lupus-Like Syndrome

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, weighing 81.7 kg (179.6 pounds)

Reactions: Menstrual Disorder, Drug Ineffective, Subcutaneous Abscess, Urticaria, Acne, Menometrorrhagia

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: ^inhalers FOR Asthma^



Possible Remicade side effects in male

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

Patient: male, weighing 35.3 kg (77.7 pounds)

Reactions: Adenoviral Upper Respiratory Infection, Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    End date: 2009-07-09

Remicade
    Start date: 2007-01-12

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



Possible Remicade side effects in female

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

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Prednisone TAB; Antibiotic (Not Specified); Tacrolimus; Humira; Azathioprine Sodium



Possible Remicade side effects in male

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

Patient: male, weighing 26.7 kg (58.7 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Indication: Crohn's Disease
    Start date: 2011-12-04
    End date: 2012-01-20

Remicade
    Indication: Crohn's Disease

Remicade
    Start date: 2011-12-06

Remicade

Other drugs received by patient: Multivitamin; Ferrous Sulfate TAB; Cholecalciferol; Cefdinir; Folic Acid; Oxycodone / Acetaminophen; Hydrocortisone; Metronidazole; Calcium Carbonate; Acetaminophen



Possible Remicade side effects in female

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

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Drug Ineffective, RED Blood Cell Sedimentation Rate Increased

Drug(s) suspected as cause:
Remicade

Remicade
    Indication: Crohn's Disease
    Start date: 2012-04-01



Possible Remicade side effects in female

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

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Hypotension, Tachycardia, Pyrexia, Gastrointestinal Infection, Malaise, Decreased Immune Responsiveness, Bacterial Toxaemia, Dehydration, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Dosage: after 15 days second dose of infliximab was received
    Start date: 2012-07-20

Remicade
    Indication: Psoriatic Arthropathy

Remicade
    Start date: 2012-07-05

Other drugs received by patient: Levothyroxine Sodium; Levothyroxine Sodium



Possible Remicade side effects in female

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

Patient: female

Reactions: Visual Field Defect, Herpes Zoster, Infusion Related Reaction

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

Remicade
    Indication: Colitis
    Start date: 2012-08-17

Other drugs received by patient: Levothyroxine Sodium; ALL Other Therapeutic Products; Lyrica; Calcort; Calcichew D3



Possible Remicade side effects in male

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

Patient: male

Reactions: Hernia

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: Drug Ineffective, Haemorrhage, Colon Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Remicade
    Start date: 2012-07-01
    End date: 2012-07-01



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 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 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

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