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Remicade (Infliximab) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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

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 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 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 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 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 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



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

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