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Remicade Side Effects

PatientsVille

Common Remicade Side Effects


The most commonly reported Remicade side effects (click to view or check a box to report):

Infusion Related Reaction (4518)
Dyspnoea (2127)
Arthralgia (1311)
Pyrexia (1277)
Nausea (1234)
Vomiting (1172)
Pneumonia (1135)
Crohn's Disease (1070)
Headache (1063)
Diarrhoea (1000)
Abdominal Pain (866)
Malaise (863)
Chest Pain (844)
Rash (835)
Flushing (782)
Chest Discomfort (756)
Pain (747)
Tuberculosis (722)
Fall (722)
Dizziness (713)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Remicade Side Effects Reported to FDA



Remicade Side Effect Report#9999746
Blood Pressure Increased, Infusion Related Reaction, Tremor, Feeling Abnormal
This is a report of a 65-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: 0,2,6 Then Every 8 Weeks, start time: 2007), combined with: NA. and developed a serious reaction and side effect(s): Blood Pressure Increased, Infusion Related Reaction, Tremor, Feeling Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in male patients, resulting in Blood Pressure Increased side effect.
Remicade Side Effect Report#9999695
Bk Virus Infection
This report suggests a potential Remicade Bk Virus Infection side effect(s) that can have serious consequences. A 40-year-old male patient (weight: NA) from LB was diagnosed with the following symptoms/conditions: colitis ulcerative and used Remicade (dosage: NA) starting 2013. After starting Remicade the patient began experiencing various side effects, including: Bk Virus InfectionAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bk Virus Infection, may still occur.
Remicade Side Effect Report#9999694
Infected Fistula, Intestinal Resection
This Infected Fistula problem was reported by a consumer or non-health professional from CA. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On
Aug 26, 2013 this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time: NA. When using Remicade, the patient experienced the following unwanted symptoms/side effects: Infected Fistula, Intestinal ResectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Infected Fistula, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9999693
Rheumatoid Arthritis, Pulmonary Oedema, Lung Disorder
This Rheumatoid Arthritis side effect was reported by a consumer or non-health professional from US. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Remicade (drug dosage: NA), which was initiated on 201310. Concurrently used drugs:
  • Methotrexate
  • Levoxyl
  • Crestor
  • Omeprazole
  • Losartan
  • Amlodipine
  • Meloxicam
.After starting to take Remicade the consumer reported adverse symptoms, such as: Rheumatoid Arthritis, Pulmonary Oedema, Lung DisorderThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9999691
Basal Cell Carcinoma, Exposure During Pregnancy
This is a report of a 37-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: NA, start time: 2011), combined with:
  • 6-mercaptopurine
and developed a serious reaction and side effect(s): Basal Cell Carcinoma, Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Basal Cell Carcinoma side effect.
Remicade Side Effect Report#9999549
Neonatal Respiratory Distress Syndrome, Atrial Septal Defect, Patent Ductus Arteriosus, Neonatal Pneumonia, Foetal Exposure During Pregnancy, Premature Baby
This report suggests a potential Remicade Neonatal Respiratory Distress Syndrome side effect(s) that can have serious consequences. A female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: ^mother^s Dosing^) starting
Nov 08, 2012. After starting Remicade the patient began experiencing various side effects, including: Neonatal Respiratory Distress Syndrome, Atrial Septal Defect, Patent Ductus Arteriosus, Neonatal Pneumonia, Foetal Exposure During Pregnancy, Premature BabyAdditional drugs used concurrently:
  • Azathioprine (Mother^s Dosing)
  • Prednisolone (Dose: 5 [mg/2d].??mother^s Dosing)
  • Folic Acid (Mother^s Dosing.)
Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neonatal Respiratory Distress Syndrome, may still occur.
Remicade Side Effect Report#9999548
Meconium In Amniotic Fluid, Foetal Heart Rate Deceleration Abnormality, Pre-eclampsia, Exposure During Pregnancy
This Meconium In Amniotic Fluid problem was reported by a physician from DE. A 23-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On
Nov 08, 2012 this consumer started treatment with Remicade (dosage: 1 Trimester, 0-30 Gestational Week). The following drugs were being taken at the same time:
  • Azathioprine (1 Trimester, 0-37 Gestational Week)
  • Prednisolone (1 Trimester, 0- 2.3 Gestational Week)
  • Multivitamins (1 Trimester, 5.2-35.4 Gestational Week)
When using Remicade, the patient experienced the following unwanted symptoms/side effects: Meconium In Amniotic Fluid, Foetal Heart Rate Deceleration Abnormality, Pre-eclampsia, Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Meconium In Amniotic Fluid, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9999474
Paralysis
This Paralysis side effect was reported by a consumer or non-health professional from US. A 17-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Remicade (drug dosage: NA), which was initiated on 201304. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: ParalysisThese side effects may potentially be related to Remicade.
Remicade Side Effect Report#9999108
Squamous Cell Carcinoma
This is a report of a 48-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: psoriasis, who was treated with Remicade (dosage: NA, start time:
Dec 15, 2011), combined with:
  • Paracetamol
  • Vitamin B
  • Acitretin
  • Hydroxycarbamide
  • Fluoxetine
  • Fluoxetine
  • Co-amoxiclav
and developed a serious reaction and side effect(s): Squamous Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in male patients, resulting in Squamous Cell Carcinoma side effect.
Remicade Side Effect Report#9997221
Psoriasis, Alopecia
This report suggests a potential Remicade Psoriasis side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Remicade (dosage: NA) starting NS. After starting Remicade the patient began experiencing various side effects, including: Psoriasis, AlopeciaAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Psoriasis, may still occur.
Remicade Side Effect Report#9997220
Oral Surgery
This Oral Surgery problem was reported by a consumer or non-health professional from CA. A 17-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time: NA. When using Remicade, the patient experienced the following unwanted symptoms/side effects: Oral SurgeryAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oral Surgery, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9996021
Uveitis
This Uveitis side effect was reported by a health professional from RU. A 24-year-old male patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis.The patient was prescribed Remicade (drug dosage: 300-400 Mg Per Infusion (also Reported As 5 Mg/kg)), which was initiated on 201110. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: UveitisThese side effects may potentially be related to Remicade.
Remicade Side Effect Report#9995736
Brain Neoplasm
This is a report of a 14-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade 5 Mg/kg/dose Janssen Research And Development (dosage: 5mg/kg/dose Every 8 Weeks Intravenous, start time:
Jan 17, 2012), combined with:
  • 6-mercaptopurine
  • Pentasa
and developed a serious reaction and side effect(s): Brain Neoplasm after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade 5 Mg/kg/dose Janssen Research And Development treatment in male patients, resulting in Brain Neoplasm side effect.
Remicade Side Effect Report#9995667
Carpal Tunnel Syndrome, Dental Caries, Musculoskeletal Stiffness, Upper Respiratory Tract Infection
This report suggests a potential Remicade Carpal Tunnel Syndrome side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Remicade (dosage: One And Half Or 2 Yesrs Ago) starting NS. After starting Remicade the patient began experiencing various side effects, including: Carpal Tunnel Syndrome, Dental Caries, Musculoskeletal Stiffness, Upper Respiratory Tract InfectionAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Carpal Tunnel Syndrome, may still occur.
Remicade Side Effect Report#9995661
Angina Pectoris
This Angina Pectoris problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On 2000 this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time:
  • Solu-medrol
  • Prednisone
  • Sumatriptan
  • Lasix
  • Potassium Chloride
  • Zoloft
  • Estradiol
  • Losartan
When using Remicade, the patient experienced the following unwanted symptoms/side effects: Angina PectorisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Angina Pectoris, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9994915
Pneumonia, Histoplasmosis, Dialysis
This Pneumonia side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: sarcoidosis.The patient was prescribed Remicade (drug dosage: As Needed Infusion), which was initiated on
Aug 29, 2013. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: Pneumonia, Histoplasmosis, DialysisThese side effects may potentially be related to Remicade. The patient was hospitalized and became disabled.
Remicade Side Effect Report#9994811
Crohn^s Disease, Ileal Stenosis
This is a report of a 21-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: NA, start time:
Mar 02, 2011), combined with:
  • Cimzia
  • Folic Acid
  • Iron
  • Multivitamins
  • Calcium Citrate
and developed a serious reaction and side effect(s): Crohn^s Disease, Ileal Stenosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Crohn^s Disease side effect. The patient was hospitalized.
Remicade Side Effect Report#9994684
Dyspnoea, Back Pain
This report suggests a potential Remicade Dyspnoea side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: ankylosing spondylitis and used Remicade (dosage: 500mg Q6w) starting
Feb 02, 2012. After starting Remicade the patient began experiencing various side effects, including: Dyspnoea, Back PainAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Remicade Side Effect Report#9992829
Skin Lesion
This Skin Lesion problem was reported by a health professional from CA. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time:
  • Prednisone
  • Imuran
When using Remicade, the patient experienced the following unwanted symptoms/side effects: Skin LesionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Skin Lesion, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9992828
Deafness, Ear Disorder
This Deafness side effect was reported by a health professional from CA. A 27-year-old female patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Remicade (drug dosage: NA), which was initiated on
Aug 09, 2013. Concurrently used drugs:
  • Hydrocortisone
  • Synthroid
  • Cholecalciferol
  • Levothyroxine
  • Flagyl
  • Folic Acid
  • Multivitamins
  • Clonazepam
.After starting to take Remicade the consumer reported adverse symptoms, such as: Deafness, Ear DisorderThese side effects may potentially be related to Remicade.
Remicade Side Effect Report#9992826
Metabolic Disorder, Mental Disorder, Back Injury, Weight Decreased, Eating Disorder, Insomnia
This is a report of a female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Remicade (dosage: NA, start time:
Nov 20, 2007), combined with: NA. and developed a serious reaction and side effect(s): Metabolic Disorder, Mental Disorder, Back Injury, Weight Decreased, Eating Disorder, Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Metabolic Disorder side effect. The patient was hospitalized.
Remicade Side Effect Report#9992540
Nausea, Vomiting
This report suggests a potential Remicade Nausea side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: NA) starting
Oct 16, 2013. After starting Remicade the patient began experiencing various side effects, including: Nausea, VomitingAdditional drugs used concurrently: NA.The patient was hospitalized. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Remicade Side Effect Report#9992535
Confusional State, Aphasia, Encephalopathy, Epilepsy, Neurological Symptom, Off Label Use
This Confusional State problem was reported by a pharmacist from AT. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: preoperative care. On
Sep 12, 2012 this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time:
  • Vasonit
  • Rifoldin
  • Concor
  • Dalacin
When using Remicade, the patient experienced the following unwanted symptoms/side effects: Confusional State, Aphasia, Encephalopathy, Epilepsy, Neurological Symptom, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Confusional State, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9989178
Anaphylactic Reaction, Infusion Related Reaction
This Anaphylactic Reaction side effect was reported by a health professional from FR. A 8-year-old female patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Remicade (drug dosage: NA), which was initiated on
Aug 24, 2012. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: Anaphylactic Reaction, Infusion Related ReactionThese side effects may potentially be related to Remicade.
Remicade Side Effect Report#9988843
Basal Cell Carcinoma
This is a report of a female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Basal Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Basal Cell Carcinoma side effect.


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The appearance of Remicade on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Remicade Side Effects for Women?

Women Side EffectsReports
Infusion Related Reaction 2822
Dyspnoea 1374
Arthralgia 878
Nausea 851
Vomiting 776
Headache 751
Pyrexia 699
Pneumonia 681
Diarrhoea 633
Breast Cancer 614

What are common Remicade Side Effects for Men?

Men Side EffectsReports
Infusion Related Reaction 1653
Dyspnoea 740
Pyrexia 575
Crohn's Disease 475
Pneumonia 451
Arthralgia 425
Vomiting 385
Nausea 373
Diarrhoea 362
Tuberculosis 336

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Remicade reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Remicade Side Effects

    Did You Have a Remicade Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Remicade for You?

    Exceeded Expectations
    Effective
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    Not Effective

    Remicade Safety Alerts, Active Ingredients, Usage Information

    NDC57894-030
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameREMICADE
    Nameinfliximab
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteINTRAVENOUS
    On market since19980824
    LabelerJanssen Biotech, Inc.
    Active Ingredient(s)INFLIXIMAB
    Strength(s)100
    Unit(s)mg/10mL
    Pharma ClassTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]

    More About Remicade

    Side Effects reported to FDA: 46150

    Remicade safety alerts: 2009 2008 2004 2001

    Reported deaths: 3861

    Reported hospitalizations: 21502

    Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009

    Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists

    [UPDATED 08/31/2009] Supplemental Q&As added

    [Posted 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

    TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohnâ??s disease, and ankylosing spondylitis.

    [08/28/2009 - Q&As - FDA]
    [08/04/2009 - Information for Healthcare Professionals - FDA]
    [08/04/2009 - Follow-up to Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers - FDA]

    Previous MedWatch Alert:

    [06/03/2008]

     

    Latest Remicade clinical trials