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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#9921163
Crohn^s Disease
This is a report of a 12-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: NA, start time:
Sep 21, 2012), combined with:
  • 5-asa
  • Prednisone
  • Budesonide
  • Cholecalciferol
  • Hyoscyamine
  • Omeprazole
  • Multivitamins
  • Omega 3
and developed a serious reaction and side effect(s): Crohn^s Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in male patients, resulting in Crohn^s Disease side effect. The patient was hospitalized.
Remicade Side Effect Report#9921162
Crohn^s Disease
This report suggests a potential Remicade Crohn^s Disease side effect(s) that can have serious consequences. A 12-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: NA) starting
Jan 06, 2013. After starting Remicade the patient began experiencing various side effects, including: Crohn^s DiseaseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Crohn^s Disease, may still occur.
Remicade Side Effect Report#9921161
Intestinal Obstruction, Dehydration
This Intestinal Obstruction problem was reported by a physician from US. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: inflammatory bowel disease. On
May 18, 2011 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: Intestinal Obstruction, DehydrationThe 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 Intestinal Obstruction, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9919455
Herpes Zoster
This Herpes Zoster side effect was reported by a health professional from FR. A 84-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 NS. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: Herpes ZosterThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9919374
Type 2 Diabetes Mellitus
This is a report of a 65-year-old 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:
Mar 21, 2013), combined with:
  • Zofran
  • Prednisone
  • Lansoprazole
  • Metronidazole
  • Pantoloc
  • Cipro
  • Calcium
  • Azothioprine
and developed a serious reaction and side effect(s): Type 2 Diabetes Mellitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Type 2 Diabetes Mellitus side effect.
Remicade Side Effect Report#9919254
Nasal Septum Deviation
This report suggests a potential Remicade Nasal Septum Deviation side effect(s) that can have serious consequences. A 28-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: NA) starting
Jul 20, 2010. After starting Remicade the patient began experiencing various side effects, including: Nasal Septum DeviationAdditional drugs used concurrently:
  • Benadryl
  • Prednisone
Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nasal Septum Deviation, may still occur.
Remicade Side Effect Report#9919253
Inflammatory Bowel Disease
This Inflammatory Bowel Disease problem was reported by a consumer or non-health professional from CA. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On 201212 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: Inflammatory Bowel DiseaseThe 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 Inflammatory Bowel Disease, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9919227
Presyncope, Conjunctivitis, Dyspnoea, Chills, Urticaria, Abdominal Pain Upper, Infusion Related Reaction
This Presyncope side effect was reported by a physician from EC. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Remicade (drug dosage: Second Infusion), which was initiated on
Feb 07, 2014. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: Presyncope, Conjunctivitis, Dyspnoea, Chills, Urticaria, Abdominal Pain Upper, Infusion Related ReactionThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9919226
Peripheral Vascular Disorder
This is a report of a 90-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Remicade (dosage: Patient Had Received 106 Infliximab Infusions, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Peripheral Vascular Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in male patients, resulting in Peripheral Vascular Disorder side effect. The patient was hospitalized.
Remicade Side Effect Report#9919203
Hidradenitis
This report suggests a potential Remicade Hidradenitis side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: Once Every 4-5 Weeks) starting 2008. After starting Remicade the patient began experiencing various side effects, including: HidradenitisAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hidradenitis, may still occur.
Remicade Side Effect Report#9919192
Systemic Lupus Erythematosus
This Systemic Lupus Erythematosus problem was reported by a health professional from CA. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On
Feb 10, 2014 this consumer started treatment with Remicade (dosage: First Dose). The following drugs were being taken at the same time: NA. When using Remicade, the patient experienced the following unwanted symptoms/side effects: Systemic Lupus ErythematosusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Systemic Lupus Erythematosus, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9919183
Hernia
This Hernia side effect was reported by a health professional from CA. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative,crohn^s disease.The patient was prescribed Remicade (drug dosage: NA), which was initiated on
Feb 02, 2014. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: HerniaThese side effects may potentially be related to Remicade.
Remicade Side Effect Report#9917530
Venous Thrombosis Limb
This is a report of a 17-year-old 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:
  • Ursodiol
  • Imuran
  • Asacol
and developed a serious reaction and side effect(s): Venous Thrombosis Limb after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Venous Thrombosis Limb side effect. The patient was hospitalized.
Remicade Side Effect Report#9917521
Abdominal Abscess, Gastrointestinal Haemorrhage, Diarrhoea, Folliculitis
This report suggests a potential Remicade Abdominal Abscess side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: colitis ulcerative and used Remicade (dosage: NA) starting NS. After starting Remicade the patient began experiencing various side effects, including: Abdominal Abscess, Gastrointestinal Haemorrhage, Diarrhoea, FolliculitisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Abscess, may still occur.
Remicade Side Effect Report#9917520
Ulcerative Keratitis, Iritis, Hepatic Steatosis, Ophthalmic Herpes Simplex, Conjunctivitis Bacterial, Arthritis, Pyuria
This Ulcerative Keratitis problem was reported by a health professional from CA. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: ankylosing spondylitis. On
Oct 17, 2012 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: Ulcerative Keratitis, Iritis, Hepatic Steatosis, Ophthalmic Herpes Simplex, Conjunctivitis Bacterial, Arthritis, PyuriaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Ulcerative Keratitis, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9917519
Dyspnoea, Face Oedema, Nausea, Respiratory Tract Oedema, Infusion Related Reaction
This Dyspnoea side effect was reported by a physician from IT. A 26-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Remicade (drug dosage: 3rd Infusion), which was initiated on
Jul 02, 2010. Concurrently used drugs: NA..After starting to take Remicade the consumer reported adverse symptoms, such as: Dyspnoea, Face Oedema, Nausea, Respiratory Tract Oedema, Infusion Related ReactionThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9917518
Vascular Occlusion, Blood Pressure Decreased
This is a report of a 53-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Remicade (dosage: NA, start time: 200803), combined with:
  • Arava
  • Prednisone
  • Methotrexate
and developed a serious reaction and side effect(s): Vascular Occlusion, Blood Pressure Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in female patients, resulting in Vascular Occlusion side effect.
Remicade Side Effect Report#9917517
Exposure During Pregnancy, Abortion Spontaneous, Muscle Spasms
This report suggests a potential Remicade Exposure During Pregnancy side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: crohn^s disease and used Remicade (dosage: Everyu 8 Week/52) starting
Feb 18, 2014. After starting Remicade the patient began experiencing various side effects, including: Exposure During Pregnancy, Abortion Spontaneous, Muscle SpasmsAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Exposure During Pregnancy, may still occur.
Remicade Side Effect Report#9917515
Autoimmune Disorder, Pityriasis Lichenoides Et Varioliformis Acuta, Colitis
This Autoimmune Disorder problem was reported by a consumer or non-health professional from CA. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On
Nov 08, 2013 this consumer started treatment with Remicade (dosage: Week 6). The following drugs were being taken at the same time: NA. When using Remicade, the patient experienced the following unwanted symptoms/side effects: Autoimmune Disorder, Pityriasis Lichenoides Et Varioliformis Acuta, ColitisThe 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 Autoimmune Disorder, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9916391
Pneumonia, Cardiomegaly, Clostridium Difficile Infection, Local Swelling
This Pneumonia side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Remicade (drug dosage: NA), which was initiated on 201311. Concurrently used drugs:
  • Prednisone
  • Imuran
  • Ferrous Sulphate
  • Multivitamins
  • Losartan
  • Levothyroxine
.After starting to take Remicade the consumer reported adverse symptoms, such as: Pneumonia, Cardiomegaly, Clostridium Difficile Infection, Local SwellingThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9916390
Abortion Spontaneous, Exposure During Pregnancy
This is a report of a 32-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Remicade (dosage: NA, start time: NS), combined with:
  • Imuran
and developed a serious reaction and side effect(s): Abortion Spontaneous, 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 Abortion Spontaneous side effect.
Remicade Side Effect Report#9916222
Nerve Compression
This report suggests a potential Remicade Nerve Compression side effect(s) that can have serious consequences. A male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: psoriatic arthropathy and used Remicade (dosage: NA) starting 201306. After starting Remicade the patient began experiencing various side effects, including: Nerve CompressionAdditional drugs used concurrently: NA. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nerve Compression, may still occur.
Remicade Side Effect Report#9916214
Squamous Cell Carcinoma, Vaginal Operation, Vulvar Dysplasia, Skin Cancer
This Death problem was reported by a health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 17, 2013 this consumer started treatment with Remicade (dosage: NA). The following drugs were being taken at the same time:
  • Humira
  • Nexium
When using Remicade, the patient experienced the following unwanted symptoms/side effects: Squamous Cell Carcinoma, Vaginal Operation, Vulvar Dysplasia, Skin CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Remicade Side Effect Report#9916213
Myocardial Infarction, Cardiomyopathy, Nervous System Disorder, Reiter^s Syndrome, Staphylococcal Infection, Pseudomonas Infection, Off Label Use
This Myocardial Infarction side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: reiter^s syndrome.The patient was prescribed Remicade (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Indocin (indometacin)
  • Prednisone
  • Toprol
.After starting to take Remicade the consumer reported adverse symptoms, such as: Myocardial Infarction, Cardiomyopathy, Nervous System Disorder, Reiter^s Syndrome, Staphylococcal Infection, Pseudomonas Infection, Off Label UseThese side effects may potentially be related to Remicade. The patient was hospitalized.
Remicade Side Effect Report#9916208
Fistula
This is a report of a 36-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Remicade (dosage: NA, start time: 201112), combined with:
  • Nasonex
  • Pantoloc
and developed a serious reaction and side effect(s): Fistula after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Remicade treatment in male patients, resulting in Fistula 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.

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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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    How Effective is Remicade for You?

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    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

    Latest Remicade clinical trials