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Remicade Side Effects

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.

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.

Remicade Side Effects Reported to FDA

The following 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.


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.
Crohn^s Disease
This is a report of a 12-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Crohn^s Disease
which developed 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.

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. Soon after starting Remicade the patient began experiencing various side effects, including:
  • Crohn^s Disease
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.

Intestinal Obstruction, Dehydration
This Intestinal Obstruction, Dehydration 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 commencing Remicade, the patient experienced the following unwanted symptoms/side effects:
  • Intestinal Obstruction
  • Dehydration
The 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.

Herpes Zoster
This is a report of a 84-year-old female patient (weight: NA) from FR. The patient developed the following symptoms/conditions: crohn^s disease and was treated with Remicade (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Herpes Zoster
The patient was hospitalized. This opens a possibility that Remicade treatment could cause the above reactions, including herpes zoster, and some female subjects may be more susceptible.


Type 2 Diabetes Mellitus
A 65-year-old female patient (weight: NA) from CA with the following symptoms/conditions: crohn^s disease started Remicade treatment (dosage: NA) on Mar 21, 2013. Soon after starting Remicade treatment, the subject experienced various side effects, including:
  • Type 2 Diabetes Mellitus
Concurrently used drugs:
  • Zofran
  • Prednisone
  • Lansoprazole
  • Metronidazole
  • Pantoloc
  • Cipro
  • Calcium
  • Azothioprine
This finding indicates that some female patients could be more vulnerable to Remicade.

Nasal Septum Deviation
A 28-year-old male patient from CA (weight: NA) experienced symptoms, such as: crohn^s disease and was treated with Remicade(dosage: NA). The treatment was initiated on Jul 20, 2010. After that a consumer reported the following side effect(s):
  • Nasal Septum Deviation
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Remicade efficacy:
  • Benadryl
  • Prednisone


Inflammatory Bowel Disease
In this report, Remicade was administered for the following condition: colitis ulcerative.A 29-year-old female consumer from CA (weight: NA) started Remicade treatment (dosage: NA) on 201212.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Inflammatory Bowel Disease
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Remicade treatment could be related to the listed above side effect(s).

Presyncope, Conjunctivitis, Dyspnoea, Chills, Urticaria, Abdominal Pain Upper, Infusion Related Reaction
This is a report of the following Remicade side effect(s):
  • Presyncope
  • Conjunctivitis
  • Dyspnoea
  • Chills
  • Urticaria
  • Abdominal Pain Upper
  • Infusion Related Reaction
A 60-year-old male patient from EC (weight: NA) presented with the following condition: colitis ulcerative and received a treatment with Remicade (dosage: Second Infusion) starting: Feb 07, 2014.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Remicade treatment could be associated with the listed above side effect(s).

Peripheral Vascular Disorder
This Remicade report was submitted by a 90-year-old male consumer from CA (weight: NA). The patient was diagnosed with: rheumatoid arthritis and Remicade was administered (dosage: Patient Had Received 106 Infliximab Infusions) starting: NS. The consumer developed a set of symptoms:
  • Peripheral Vascular Disorder
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Remicade treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hidradenitis
This is a report of a possible correlation between Remicade use and the following symptoms/side effect(s):
  • Hidradenitis
which could contribute to an assessment of Remicade risk profile.A female consumer from US (weight: NA) was suffering from crohn^s disease and was treated with Remicade (dosage: Once Every 4-5 Weeks) starting 2008.Other concurrent medications: NA.

Systemic Lupus Erythematosus
A 39-year-old female patient from CA (weight: NA) presented with the following symptoms: crohn^s disease and after a treatment with Remicade (dosage: First Dose) experienced the following side effect(s):
  • Systemic Lupus Erythematosus
The treatment was started on Feb 10, 2014. Remicade was used in combination with the following drugs: NA.This report could alert potential Remicade consumers.

Hernia
In this report, a 53-year-old female patient from CA (weight: NA) was affected by a possible Remicade side effect.The patient was diagnosed with colitis ulcerative,crohn^s disease. After a treatment with Remicade (dosage: NA, start date: Feb 02, 2014), the patient experienced the following side effect(s):
  • Hernia
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Remicade treatment.

Venous Thrombosis Limb
This is a report of a 17-year-old female patient from CA (weight: NA), who used Remicade (dosage: NA) for a treatment of crohn^s disease. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Venous Thrombosis Limb
The following drugs could possibly have interacted with the Remicade treatment
  • Ursodiol
  • Imuran
  • Asacol
The patient was hospitalized.Taken together, these observations suggest that a Remicade treatment could be related to side effect(s), such as Venous Thrombosis Limb.

Abdominal Abscess, Gastrointestinal Haemorrhage, Diarrhoea, Folliculitis
This abdominal abscess side effect was reported by a health professional from CA. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative. The patient was prescribed Remicade (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Remicade the consumer reported the following symptoms:
  • Abdominal Abscess
  • Gastrointestinal Haemorrhage
  • Diarrhoea
  • Folliculitis
The patient was hospitalized. These side effects may potentially be related to Remicade.

Ulcerative Keratitis, Iritis, Hepatic Steatosis, Ophthalmic Herpes Simplex, Conjunctivitis Bacterial, Arthritis, Pyuria
This is a Remicade side effect report of a female patient (weight:NA) from CA, suffering from the following symptoms/conditions: ankylosing spondylitis, who was treated with Remicade (dosage:NA, start time: Oct 17, 2012), combined with: NA., and developed a serious reaction and a ulcerative keratitis side effect. The patient presented with:
  • Ulcerative Keratitis
  • Iritis
  • Hepatic Steatosis
  • Ophthalmic Herpes Simplex
  • Conjunctivitis Bacterial
  • Arthritis
  • Pyuria
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Remicade treatment in female patients suffering from ankylosing spondylitis, resulting in ulcerative keratitis.

Dyspnoea, Face Oedema, Nausea, Respiratory Tract Oedema, Infusion Related Reaction
This report suggests a potential Remicade dyspnoea side effect(s) that can have serious consequences. A 26-year-old male patient from IT (weight:NA) was diagnosed with the following health condition(s): colitis ulcerative and used Remicade (dosage: 3rd Infusion) starting Jul 02, 2010. Soon after starting Remicade the patient began experiencing various side effects, including:
  • Dyspnoea
  • Face Oedema
  • Nausea
  • Respiratory Tract Oedema
  • Infusion Related Reaction
Drugs used concurrently:NA. The patient was hospitalized. Although Remicade demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dyspnoea, may still occur.

Vascular Occlusion, Blood Pressure Decreased
This vascular occlusion problem was reported by a consumer or non-health professional from BR. A 53-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): rheumatoid arthritis.On 200803 a consumer started treatment with Remicade (dosage: NA). The following drugs/medications were being taken at the same time:
  • Arava
  • Prednisone
  • Methotrexate
When commencing Remicade, the patient experienced the following unwanted symptoms /side effects:
  • Vascular Occlusion
  • Blood Pressure Decreased
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as vascular occlusion, may become evident only after a product is in use by the general population.

Exposure During Pregnancy, Abortion Spontaneous, Muscle Spasms
This is a Remicade side effect report of a 28-year-old female patient (weight: NA) from CA. The patient developed the following symptoms/conditions: crohn^s disease and was treated with Remicade (dosage: Everyu 8 Week/52) starting Feb 18, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Exposure During Pregnancy
  • Abortion Spontaneous
  • Muscle Spasms
This opens a possibility that Remicade could cause exposure during pregnancy and that some female patients may be more susceptible.

Autoimmune Disorder, Pityriasis Lichenoides Et Varioliformis Acuta, Colitis
A 29-year-old male patient (weight: NA) from CA with the following symptoms: crohn^s disease started Remicade treatment (dosage: Week 6) on Nov 08, 2013. Soon after starting Remicade treatment, the consumer experienced several side effects, including:
  • Autoimmune Disorder
  • Pityriasis Lichenoides Et Varioliformis Acuta
  • Colitis
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Remicade side effects, such as autoimmune disorder.

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 (dosage: NA), which was started on 201311. Concurrently used drugs:
  • Prednisone
  • Imuran
  • Ferrous Sulphate
  • Multivitamins
  • Losartan
  • Levothyroxine
.When starting to take Remicade the consumer reported symptoms, such as:
  • Pneumonia
  • Cardiomegaly
  • Clostridium Difficile Infection
  • Local Swelling
These side effects may potentially be related to Remicade. The patient was hospitalized.

Abortion Spontaneous, Exposure During Pregnancy
This is a report of a 32-year-old female patient (weight: NA) from CA, suffering from the following 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). The consumer presented with:
  • Abortion Spontaneous
  • Exposure During Pregnancy
which developed 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.

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. Soon after starting Remicade the patient began experiencing various side effects, including:
  • Nerve Compression
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.

Squamous Cell Carcinoma, Vaginal Operation, Vulvar Dysplasia, Skin Cancer
This Squamous Cell Carcinoma, Vaginal Operation, Vulvar Dysplasia, Skin Cancer 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 commencing Remicade, the patient experienced the following unwanted symptoms/side effects:
  • Squamous Cell Carcinoma
  • Vaginal Operation
  • Vulvar Dysplasia
  • Skin Cancer
Although 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.

Myocardial Infarction, Cardiomyopathy, Nervous System Disorder, Reiter^s Syndrome, Staphylococcal Infection, Pseudomonas Infection, Off Label Use
This is a report of a male patient (weight: NA) from US. The patient developed the following symptoms/conditions: reiter^s syndrome and was treated with Remicade (dosage: NA) starting NS. Concurrently used drugs:
  • Indocin (indometacin)
  • Prednisone
  • Toprol
Soon after that, the consumer experienced the following side effects:
  • Myocardial Infarction
  • Cardiomyopathy
  • Nervous System Disorder
  • Reiter^s Syndrome
  • Staphylococcal Infection
  • Pseudomonas Infection
  • Off Label Use
The patient was hospitalized. This opens a possibility that Remicade treatment could cause the above reactions, including myocardial infarction, and some male subjects may be more susceptible.

Fistula
A 36-year-old male patient (weight: NA) from CA with the following symptoms/conditions: crohn^s disease started Remicade treatment (dosage: NA) on 201112. Soon after starting Remicade treatment, the subject experienced various side effects, including:
  • Fistula
Concurrently used drugs:
  • Nasonex
  • Pantoloc
This finding indicates that some male patients could be more vulnerable to Remicade.

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Top 10 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

Top 10 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

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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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