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 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 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 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 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 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 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 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 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 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 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 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 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
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