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 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 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 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
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 male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 95.0 kg (209.0 pounds)
Reactions: Facial Lesion Excision
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 46 year old female
Reported by a physician from United States on 2012-08-27
Patient: 46 year old female
Reactions: Acute Respiratory Distress Syndrome, Knee Arthroplasty, Bronchiolitis
Drug(s) suspected as cause:
Remicade
Indication: Rheumatoid Arthritis
Start date: 2012-08-06
Remicade
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 106.6 kg (234.5 pounds)
Reactions: Pruritus, Chest Discomfort, Hypersensitivity, Drug Ineffective, Diabetes Mellitus, Chills, Urticaria, Headache, Osteoarthritis, Vitamin D Decreased, Alopecia, Insomnia, Animal Scratch, Skin Atrophy
Drug(s) suspected as cause:
Cortisone Acetate
Indication: Rheumatoid Arthritis
Enbrel
Indication: Rheumatoid Arthritis
Prednisone TAB
Indication: Rheumatoid Arthritis
Remicade
Indication: Rheumatoid Arthritis
Start date: 2012-07-01
Remicade
Dosage: every 6 to 8 weeks
Start date: 2003-01-01
End date: 2006-01-01
Other drugs received by patient: Methotrexate; Prednisone TAB; Norco
Possible Remicade side effects in male
Reported by a physician from Japan on 2012-08-27
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Tubulointerstitial Nephritis, Renal Impairment
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Indication: Behcet's Syndrome
Start date: 2007-11-01
Remicade
Remicade
Dosage: 18th dose
Start date: 2012-05-01
Unknown Medication
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Adalat; Celectol; Prednisolone
Possible Remicade side effects in male
Reported by a physician from Canada on 2012-08-27
Patient: male
Reactions: Respiratory Disorder
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in female
Reported by a pharmacist from United States on 2012-08-27
Patient: female
Reactions: Brain Neoplasm
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 51.2 kg (112.6 pounds)
Reactions: Weight Decreased, Nasopharyngitis, Mouth Ulceration, Pain, Psoriasis, Pallor, Dysphonia, Fungal Infection, Asthenia
Drug(s) suspected as cause:
Methotrexate
Methotrexate
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-15
Remicade
Dosage: has had 20 inflixiamb infusions
Start date: 2012-08-16
Remicade
Dosage: has had 20 inflixiamb infusions
Indication: Psoriatic Arthropathy
Start date: 2009-06-17
Other drugs received by patient: Folic Acid; Pantoprazole Sodium
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 46.0 kg (101.2 pounds)
Reactions: Renal Cancer, Tooth Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Cyproheptadine HCL; Adalat CC; Entocort EC; Vitamin B-12; Citalopram Hydrobromide; Hydromorphone Hydrochloride; Lomotil; Lenoltec NOS; Hydromorphone HCL; Ativan
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 44.7 kg (98.3 pounds)
Reactions: Anal Fistula, Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Dystonia
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 26.6 kg (58.5 pounds)
Reactions: Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Prednisone TAB; Methotrexate
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Neoplasm Malignant, Crohn's Disease, Alanine Aminotransferase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2011-07-13
Remicade
Start date: 2011-05-19
Remicade
Start date: 2010-07-14
Remicade
Start date: 2010-10-14
Remicade
Start date: 2012-08-16
Remicade
Start date: 2011-09-01
Remicade
Start date: 2011-03-24
Remicade
Start date: 2011-01-27
Remicade
Start date: 2012-04-10
Remicade
Start date: 2010-08-26
Remicade
Start date: 2010-07-28
Remicade
Indication: Crohn's Disease
Start date: 2012-02-14
Remicade
Start date: 2011-12-20
Remicade
Start date: 2011-10-24
Remicade
Start date: 2010-12-06
Other drugs received by patient: Cymbalta; Clonazepam; Mercaptopurine
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-27
Patient: female
Reactions: Knee Operation, Pain, Atrophy
Drug(s) suspected as cause:
Remicade
Remicade
Indication: Rheumatoid Arthritis
Start date: 2012-07-17
Possible Remicade side effects in female
Reported by a physician from United Kingdom on 2012-08-27
Patient: female
Reactions: Maternal Exposure During Pregnancy, Crohn's Disease, Premature Labour
Drug(s) suspected as cause:
Pentasa
Indication: Product Used FOR Unknown Indication
Start date: 2008-01-01
Prednisolone
Indication: Crohn's Disease
Start date: 2008-01-01
Remicade
Indication: Crohn's Disease
Remicade
Dosage: 7.5mg/kg
Start date: 2008-01-01
Remicade
Possible Remicade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Anxiety, Infusion Related Reaction
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Premedication; Antianxiety NOS; Benadryl
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 67.0 kg (147.4 pounds)
Reactions: Nausea, Muscle Spasms
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Tylenol W / Codeine NO. 3
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Denmark on 2012-08-27
Patient: male, weighing 66.0 kg (145.2 pounds)
Reactions: Cognitive Disorder, Meningitis Aseptic
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Start date: 2009-09-09
Remicade
Indication: Crohn's Disease
Start date: 2009-12-21
End date: 2010-09-23
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 43.0 kg (94.6 pounds)
Reactions: Cholecystitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Pentasa; Entocort EC
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 62.1 kg (136.7 pounds)
Reactions: Large Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Calcium Carbonate; Atenolol; Miralax; Immune Globulin NOS; Nexium; Pulmicort; Xopenex; Coenzyme Q10; Tylenol; E Vitamin; Zofran; Selenium; Antibiotics; Benadryl; Provigil; Naltrexone Hydrochloride; Lipoic Acid; Mesalamine; Ascorbic Acid; Multi-Vitamins; Dulcolax; Riboflavin CAP; Neurontin
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-27
Patient: female
Reactions: Myalgia, Musculoskeletal Stiffness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Hydrocortisone; ALL Other Therapeutic Products
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