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 69.5 kg (152.9 pounds)
Reactions: Abdominal Pain, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Prednisone TAB
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 82.0 kg (180.4 pounds)
Reactions: Pneumonia, Pneumothorax
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 51.0 kg (112.2 pounds)
Reactions: Systemic Lupus Erythematosus
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Start date: 2009-01-01
Remicade
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 87.1 kg (191.6 pounds)
Reactions: Pain, Hyperhidrosis, Fall, Periorbital Haematoma, Body Height Decreased, Mood Altered, DRY Mouth, Oedema Peripheral, Dizziness, Mood Swings, Migraine, Back Pain, Dyspnoea, Tuberculosis, General Physical Health Deterioration, Amnesia, Dysarthria, Arthralgia, Increased Tendency To Bruise, Hypothyroidism, Gait Disturbance, Feeling Abnormal, Arthritis, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Arthritis
Start date: 2011-11-16
Remicade
Dosage: 3rd infusion
Start date: 2011-12-28
End date: 2011-12-28
Remicade
Dosage: 3rd infusion
Indication: Crohn's Disease
Start date: 2011-12-28
End date: 2011-12-28
Remicade
Start date: 2011-11-16
Other drugs received by patient: Loratadine; Albuterol; Folic Acid; Simvastatin; Promethazine; Butalbital; Atropine; Tussionex; Tylenol 3 with Codeine; Diazepam; Simvastatin; Promethazine; Calcium Carbonate; Ipratropium Bromide; Diphenoxylate; Diazepam; Zolpidem; Miralax; Cymbalta; ALL Other Therapeutic Products; Methotrexate; Omeprazole; Potassium Gluconate TAB; Diazepam; Fluticasone Propionate; Nitrofurantoin; Albuterol; Guaifenesin; Zoloft; Prednisone TAB; Miralax; Zyflamend; Oxycontin
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 107.0 kg (235.4 pounds)
Reactions: Migraine, Masked Facies
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Benadryl; Prednisone TAB; Methotrexate
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Hypersensitivity, Haemorrhage, Herpes Zoster, Scar
Drug(s) suspected as cause:
Remicade
Indication: Colitis Ulcerative
Start date: 2012-07-01
Remicade
Start date: 2010-11-01
Other drugs received by patient: Lialda; Singulair; Xyzal
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 127.0 kg (279.4 pounds)
Reactions: Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Start date: 2008-12-08
Remicade
Start date: 2012-07-12
Other drugs received by patient: Flagyl; Imuran; Chantix; Ciprofloxacin HCL
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Weight Decreased, Insomnia, Cyst, Stress
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Lipitor; Folic Acid; Norvasc; Fosamax; Methotrexate Sodium; Atacand
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 50.8 kg (111.8 pounds)
Reactions: Gastroenteritis Viral
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Calcium; Cyproheptadine HCL; Azathioprine Sodium; Iron
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: male, weighing 74.0 kg (162.8 pounds)
Reactions: Femur Fracture
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in
Reported by a physician from United States on 2012-08-27
Patient:
Reactions: Neurological Symptom
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: Surgery
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: Knee Arthroplasty
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 30.3 kg (66.7 pounds)
Reactions: Cough
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Remicade
Start date: 2012-02-16
Remicade
Indication: Inflammatory Bowel Disease
Start date: 2012-03-27
Other drugs received by patient: Miralax; Multi-Vitamins; Ciprofloxacin HCL
Possible Remicade side effects in male
Reported by a physician from United Kingdom on 2012-08-27
Patient: male, weighing 1.7 kg (3.8 pounds)
Reactions: Premature Baby
Drug(s) suspected as cause:
Pentasa
Indication: Foetal Exposure During Pregnancy
Start date: 2008-01-01
Prednisolone
Indication: Foetal Exposure During Pregnancy
Start date: 2008-01-01
Remicade
Dosage: (7.5mg/kg)
Indication: Foetal Exposure During Pregnancy
Start date: 2008-01-01
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Knee Arthroplasty
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 64.4 kg (141.7 pounds)
Reactions: Abdominal Pain Lower, Drug Ineffective, Ovarian Cyst
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Tylenol W / Codeine NO. 4; Hydromorph; Mirena
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Glossodynia, Dyspnoea, Swelling Face, Hypersensitivity, Painful Respiration, Swollen Tongue, Throat Tightness, Facial Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Unknown Medication; Tylenol; Benadryl
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male, weighing 45.8 kg (100.8 pounds)
Reactions: Clostridial Infection, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Antibiotics
Indication: Inflammatory Bowel Disease
Remicade
Indication: Inflammatory Bowel Disease
Start date: 2011-06-29
Other drugs received by patient: Azathioprine Sodium; Mesalamine; Mesalamine
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 109.0 kg (239.8 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Dosage: 0-2 induction dose
Start date: 2012-01-01
Remicade
Indication: Crohn's Disease
Start date: 2012-08-14
Other drugs received by patient: Methotrexate
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 45.0 kg (99.0 pounds)
Reactions: Lung Carcinoma Cell Type Unspecified Stage III
Drug(s) suspected as cause:
Remicade
Start date: 2012-08-21
Remicade
Indication: Crohn's Disease
Start date: 2006-09-01
Possible Remicade side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Osteonecrosis, Erythema Nodosum, Lymphoma
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: ALL Other Therapeutic Products; Multi-Vitamins
Possible Remicade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Thrombosis, Pulmonary Embolism
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Lialda
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Swelling Face, Dental Caries
Drug(s) suspected as cause:
Remicade
Dosage: 4-5 infusions
Indication: Colitis Ulcerative
Remicade
Start date: 2011-11-01
Remicade
Steroids NOS
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Apriso; Prednisone TAB; Solu-Medrol; Imuran; Imuran
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 86.4 kg (190.1 pounds)
Reactions: Hand Fracture, Fall
Drug(s) suspected as cause:
Remicade
Dosage: 4th infusion
Indication: Colitis Ulcerative
Start date: 2012-06-25
Remicade
Start date: 2012-04-04
Other drugs received by patient: Mesalamine
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female, weighing 56.3 kg (123.9 pounds)
Reactions: Intestinal Operation, Abscess
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 United States on 2012-08-27
Patient: female, weighing 65.8 kg (144.7 pounds)
Reactions: Oral Discomfort, Pityriasis Rosea, Rash, Depression
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Start date: 2006-06-01
Remicade
Start date: 2012-01-01
Remicade
Start date: 2011-01-01
Other drugs received by patient: ALL Other Therapeutics
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: female, weighing 91.8 kg (202.0 pounds)
Reactions: Atrial Fibrillation, Post Procedural Haemorrhage, HIP Surgery
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Start date: 2007-10-24
Remicade
Indication: Colitis
Start date: 2007-10-24
Other drugs received by patient: Potassium; Calcium; Zoplicone; Creston; Imuran; Rabeprazole Sodium; Iron; Metoprolol Tartrate; Celebrex
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Vomiting, Nausea, Drug Hypersensitivity, Headache, Paraesthesia, Loss of Consciousness, Musculoskeletal Disorder, Chest Pain, Adverse Event, Dizziness, Hypertension, Psoriatic Arthropathy
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Methotrexate; Leflunomide; Methotrexate; Methotrexate; Methotrexate
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: male, weighing 131.4 kg (289.1 pounds)
Reactions: Gout, Exfoliative Rash, Oedema Peripheral, Blister
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Indomethacin; Colchicine; Allopurinol
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