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 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 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 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 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 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
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