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 34 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 34 year old male
Reactions: Renal Cancer
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male, weighing 56.8 kg (125.0 pounds)
Reactions: Peritonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Humira; Budesonide
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 36.8 kg (81.0 pounds)
Reactions: Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Remicade
Start date: 2011-03-04
Other drugs received by patient: Antibiotics Unspecified
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: male, weighing 99.8 kg (219.5 pounds)
Reactions: Death, Gastrointestinal Haemorrhage, Drug Ineffective
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Remicade
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
Possible Remicade side effects in female
Reported by a physician from Canada on 2012-08-27
Patient: female, weighing 51.0 kg (112.2 pounds)
Reactions: Intracranial Aneurysm
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Indication: Rheumatoid Arthritis
Start date: 2010-02-10
Remicade
Start date: 2012-06-27
Other drugs received by patient: Methotrexate; Folic Acid; Actonel
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Dermatitis Allergic, Movement Disorder, Back Pain, Dyspnoea, Paralysis, Muscular Weakness, Oropharyngeal Pain, Joint Swelling, Arthralgia, Sepsis, Oedema Peripheral, Dizziness, Heart Rate Irregular
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Dipyrone INJ; Multi-Vitamins; Mesalamine
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: Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2012-05-22
Remicade
Indication: Crohn's Disease
Other drugs received by patient: Folic Acid; Oxycodone HCL; Cefdinir; Multi-Vitamins; Ferrous Sulfate TAB; Hydrocortisone; Acetaminophen; Calcium Carbonate Vitamin D; Metronidazole; Methotrexate; Cholecalciferol
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 87.0 kg (191.4 pounds)
Reactions: Weight Decreased
Drug(s) suspected as cause:
Remicade
Start date: 2012-03-01
Remicade
Indication: Crohn's Disease
Start date: 2012-03-01
Other drugs received by patient: Prednisone TAB; Accolate
Possible Remicade side effects in 14 year old male
Reported by a physician from Brazil on 2012-08-27
Patient: 14 year old male
Reactions: Lupus-Like Syndrome
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male
Reactions: Visual Impairment
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 46.8 kg (103.0 pounds)
Reactions: Psoriasis
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Calcium Carbonate; Zinc Oxide; Gris-PEG; Lamisil; Antifungal Cream
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 105.0 kg (231.0 pounds)
Reactions: Joint Swelling, Oedema Peripheral
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 76.5 kg (168.3 pounds)
Reactions: Crohn's Disease
Drug(s) suspected as cause:
Remicade
Start date: 2012-05-14
Remicade
Indication: Colitis Ulcerative
Start date: 2012-08-21
Remicade
Start date: 2012-06-25
Remicade
Start date: 2012-05-28
Other drugs received by patient: Calcium; Vitamin D; Azathioprine Sodium
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 94.8 kg (208.6 pounds)
Reactions: Breast Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2010-10-14
Remicade
Indication: Psoriasis
Start date: 2008-04-01
Possible Remicade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 82.1 kg (180.6 pounds)
Reactions: Pneumonia, Renal Failure Acute, Herpes Zoster
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 Hungary on 2012-08-27
Patient: female
Reactions: Raynaud's Phenomenon
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2012-05-16
End date: 2012-05-16
Remicade
Start date: 2012-01-17
Remicade
Indication: Colitis Ulcerative
Start date: 2010-07-30
End date: 2011-09-14
Other drugs received by patient: Accuzide; Imuran
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Colitis Ulcerative
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Iron; Prilosec; Prednisone TAB; Probiotic
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Weight Increased, Acne Pustular, Arthralgia, Joint Swelling, Diarrhoea, Chest Pain, Blepharitis, Gastritis
Drug(s) suspected as cause:
Prevacid
Administration route: Oral
Prevacid
Administration route: Oral
Indication: Gastric Disorder
Remicade
Indication: Colitis Ulcerative
Start date: 2012-04-19
Remicade
Other drugs received by patient: Prednisone TAB
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male, weighing 65.2 kg (143.4 pounds)
Reactions: Flushing, Chest Discomfort, Dyspnoea, Blood Pressure Decreased, Oxygen Saturation Decreased, Infusion Related Reaction
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Remicade
Dosage: second infusion
Start date: 2012-07-11
Remicade
Start date: 2012-06-27
Other drugs received by patient: Tylenol; Benadryl; Solu-Medrol
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: male, weighing 95.0 kg (209.0 pounds)
Reactions: Weight Decreased, Fatigue, Decreased Appetite
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 49 year old female
Reactions: Renal Failure
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in female
Reported by a physician from Finland on 2012-08-27
Patient: female
Reactions: Pruritus, Anaphylactic Reaction, Type IV Hypersensitivity Reaction, Infusion Related Reaction
Drug(s) suspected as cause:
Remicade
Dosage: strength 100 mg
Indication: Colitis Ulcerative
Start date: 2012-06-01
Remicade
Remicade
Dosage: strength 100 mg
Start date: 2012-07-05
End date: 2012-07-05
Other drugs received by patient: Pentasa; Solu-Cortef
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 52.3 kg (115.1 pounds)
Reactions: Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Mesalamine; Prednisone TAB
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Haematochezia
Drug(s) suspected as cause:
Remicade
Indication: Colitis
Start date: 2010-08-31
Remicade
Dosage: 4 vials
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 58.1 kg (127.8 pounds)
Reactions: Eye Injury, Head Injury, Eye Oedema, Fall
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 43 year old female
Reported by a physician from Spain on 2012-08-27
Patient: 43 year old female
Reactions: Mycosis Fungoides
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Systemic Lupus Erythematosus
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 69.0 kg (151.8 pounds)
Reactions: Vomiting, Diarrhoea, Nausea
Drug(s) suspected as cause:
Remicade
Start date: 2010-01-01
Remicade
Indication: Crohn's Disease
Start date: 2012-01-01
Other drugs received by patient: Imuran
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