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Remicade (Infliximab) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (13744)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Remicade (Infliximab) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 13744   Next >>

Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: female, weighing 105.0 kg (231.0 pounds)

Reactions: Flushing, Hypertension

Drug(s) suspected as cause:
Remicade
    Start date: 2009-10-01

Remicade
    Indication: Ankylosing Spondylitis
    Start date: 2012-05-23

Other drugs received by patient: Norvasc; Atenolol; Avalide; Effexor; Benadryl



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 44.4 kg (97.7 pounds)

Reactions: Cellulitis

Drug(s) suspected as cause:
Remicade
    Start date: 2012-07-20

Remicade

Remicade
    Indication: Crohn's Disease

Other drugs received by patient: Benadryl; Neurontin; Humira; Antibiotics; Dilaudid; Biotin; Vancomycin; Methotrexate; Fentanyl; Flonase; Vitamin D



Possible Remicade side effects in female

Reported by a physician from Norway on 2012-08-27

Patient: female

Reactions: Gingivitis, Pneumonia, Tooth Extraction, Tooth Infection, Pyelonephritis

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 68.0 kg (149.6 pounds)

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Mesalamine



Possible Remicade side effects in male

Reported by a physician from Japan on 2012-08-27

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Pulmonary Tuberculosis, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisolone
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2009-11-02

Remicade
    Start date: 2009-11-22

Remicade
    Dosage: 13th dose
    Indication: Crohn's Disease
    Start date: 2011-08-07

Other drugs received by patient: Elental; Protecadin; Pentasa; Gaslon



Possible Remicade side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Fall

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 71.7 kg (157.7 pounds)

Reactions: Benign Prostatic Hyperplasia

Drug(s) suspected as cause:
Remicade
    Start date: 2012-02-20

Remicade
    Dosage: had his 4th infusion on 25-may-12
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-25

Other drugs received by patient: Prednisone TAB; Naproxen; Methotrexate



Possible Remicade side effects in female

Reported by a pharmacist from Israel on 2012-08-27

Patient: female

Reactions: Endodontic Procedure, Tooth Extraction

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: Weight Decreased, Drug Ineffective, Pain, Appendix Disorder, Gallbladder Disorder, Blood Test Abnormal, Blood Glucose Increased, Infection, Influenza

Drug(s) suspected as cause:
Prednisone TAB
    Indication: Pain

Prednisone TAB
    Indication: Weight Decreased

Remicade
    Start date: 2011-01-01
    End date: 2012-01-01

Remicade
    Indication: Colitis Ulcerative
    Start date: 2012-01-01

Other drugs received by patient: Asacol HD; Metoprolol Tartrate; Hyoscyamine; Dexilant; Cymbalta; Triglide; Claritin; ALL Other Therapeutic Product; Acetaminophen, Aspirin and Caffeine; Glimepiride



Possible Remicade side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Chills, Psoriasis, Scleroderma, Infusion Related Reaction

Drug(s) suspected as cause:
Remicade
    Indication: Psoriatic Arthropathy

Stelara
    Indication: Psoriatic Arthropathy



Possible Remicade side effects in male

Reported by a physician from Spain on 2012-08-27

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Pulmonary Sarcoidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Mesalamine



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: female, weighing 79.0 kg (173.8 pounds)

Reactions: Colitis Ulcerative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2012-05-09

Remicade
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-01



Possible Remicade side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Systemic Lupus Erythematosus

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 70.0 kg (154.0 pounds)

Reactions: Cholelithiasis, Urinary Tract Infection

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 53.6 kg (117.9 pounds)

Reactions: Lupus-Like Syndrome

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Cholecalciferol; Acetaminophen; Miralax; Antibiotics FOR IBD; Bactroban



Possible Remicade side effects in

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient:

Reactions: Adverse Event

Drug(s) suspected as cause:
Remicade
    Indication: Colitis Ulcerative

Remicade
    Start date: 2012-07-17

Other drugs received by patient: Azathioprine Sodium



Possible Remicade side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: male, weighing 99.0 kg (217.8 pounds)

Reactions: Rheumatoid Arthritis, Syncope, Crohn's Disease

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2011-06-22

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-22

Other drugs received by patient: Entocort EC; Crestor; Pentasa; Prevacid; Atacand; Imuran; Percocet



Possible Remicade side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Night Sweats, Back Pain, Drug Ineffective, Tonsillitis, Skin Fissures, Arthralgia, Oedema Peripheral, Eye Pruritus, Influenza

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-07-20

Remicade
    Start date: 2012-04-13

Other drugs received by patient: Hydroxychloroquine Sulfate; ALL Other Therapeutics; Systen Conti; Harpagophytum Procumbens



Possible Remicade side effects in 54 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 54 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Arthralgia, Fibromyalgia, Bone Pain

Drug(s) suspected as cause:
Remicade
    Dosage: the dose frequency was changed from 2 months each to 1 month 15 days each.
    Start date: 2012-01-23

Remicade
    Start date: 2012-02-01

Remicade
    Indication: Crohn's Disease
    Start date: 2009-09-01

Other drugs received by patient: Alendronate Sodium; Captopril; Mesalamine; Calci-MIX



Possible Remicade side effects in 57 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 57 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Oxygen Saturation Decreased, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2012-08-01

Remicade

Remicade
    Start date: 2012-06-06

Other drugs received by patient: Prednisone TAB; Isotonic Sodium Chloride; Methotrexate



Possible Remicade side effects in male

Reported by a physician from Switzerland on 2012-08-27

Patient: male

Reactions: Thymoma Malignant

Adverse event resulted in: life threatening event, hospitalization

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 49.4 kg (108.8 pounds)

Reactions: Small Intestinal Obstruction, Perirectal Abscess, Pelvic Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2006-03-08

Remicade
    Indication: Inflammatory Bowel Disease
    Start date: 2008-01-22

Other drugs received by patient: Mesalamine; Bactrim; Iron; Prednisone TAB



Possible Remicade side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Intestinal Operation

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 63.0 kg (138.6 pounds)

Reactions: Heat Rash, Cyst

Drug(s) suspected as cause:
Remicade
    Indication: Colitis Ulcerative
    Start date: 2008-11-01

Remicade
    Dosage: 24th infusion
    Start date: 2012-08-16



Possible Remicade side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 80.9 kg (178.0 pounds)

Reactions: Subcutaneous Abscess, Dehydration, Hyponatraemia, Gastroenteritis Viral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-07-11

Remicade
    Start date: 2010-07-21

Other drugs received by patient: Iron; Calcium with Vitamin D; Multi-Vitamins



Possible Remicade side effects in 13 year old male

Reported by a physician from United States on 2012-08-27

Patient: 13 year old male

Reactions: Respiratory Disorder, Dyspnoea, Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-06-01

Remicade
    Start date: 2012-01-01

Other drugs received by patient: Benadryl; Acetaminophen; Steroids NOS



Possible Remicade side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Renal Failure, Vasculitis

Adverse event resulted in: hospitalization

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 42.0 kg (92.4 pounds)

Reactions: Female Genital Tract Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Vitamin D; Azathioprine Sodium; Miralax; Antibiotics



Possible Remicade side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Pancreatitis Acute, Small Intestinal Obstruction, Intestinal Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease

Remicade
    Start date: 2012-01-18

Remicade
    Start date: 2012-02-07

Remicade
    Start date: 2012-01-03

Other drugs received by patient: Imuran; Imuran; Antibiotics FOR IBD



Possible Remicade side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 26.7 kg (58.7 pounds)

Reactions: Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Indication: Crohn's Disease
    Start date: 2011-12-04
    End date: 2012-01-20

Remicade
    Indication: Crohn's Disease

Remicade
    Start date: 2011-12-06

Remicade

Other drugs received by patient: Multivitamin; Ferrous Sulfate TAB; Cholecalciferol; Cefdinir; Folic Acid; Oxycodone / Acetaminophen; Hydrocortisone; Metronidazole; Calcium Carbonate; Acetaminophen



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