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Drugs reference index «Remicade»



Generic Name: infliximab (Intravenous route)


Intravenous routePowder for Solution
  • Serious Infections
    • Patients treated with infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
    • Infliximab should be discontinued if a patient develops a serious infection or sepsis.
    • Reported infections include:
      • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before infliximab use and during therapy. Treatment for latent infection should be initiated prior to infliximab use.
      • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
      • Bacterial, viral and other infections due to opportunistic pathogens.
    • The risks and benefits of treatment with infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
    • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
  • Malignancy
    • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab.
    • Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patient treated with TNF blockers including infliximab. These cases have had a very aggressive disease course and have been fatal. All reported infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients received treatment with azathioprine or 6-mercaptopurine concomitantly with infliximab at or prior to diagnosis..

Patients treated with infliximab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Lymphoma and other malignancies, some fatal, have been reported in pediatric patients treated with infliximab. Rare postmarketing cases of hepatosplenic T-cell lymphoma, usually fatal, have been reported in patients with Crohn's disease and ulcerative colitis treated with infliximab. All of these hepatosplenic T-cell lymphomas with infliximab have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine .

Commonly used brand name(s):

In the U.S.

  • Remicade

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

Uses For Remicade

Infliximab is a monoclonal antibody. It is used to treat Crohn's disease in children (6 years of age and older) and adults who have not been helped by other medicines, and in adult patients who have a type of Crohn's disease where fistulas form. Infliximab is used to treat adults with rheumatoid arthritis and ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. It is used to treat adults with psoriatic arthritis, which is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body.

Infliximab is also used to treat adults with ulcerative colitis and chronic severe plaque psoriasis, which is a skin disease with red patches and white scales that don't go away.

This medicine is available only with your doctor's prescription.

Before Using Remicade

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab for the treatment of Crohn's disease in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of infliximab in children with ulcerative colitis and plaque psoriasis. Safety and efficacy have not been established.

Appropriate studies performed to date have demonstrated that infliximab is not helpful in children with juvenile rheumatoid arthritis. Efficacy has not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infliximab in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab.


Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Anakinra
  • Rilonacept

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow problems (e.g., low white blood cells, low platelets) or
  • Coccidioidomycosis (fungus infection), history of or
  • Diabetes or
  • Guillain-Barre syndrome, history of or
  • Hepatitis B, active or history of or
  • Histoplasmosis (fungus infection), history of or
  • Liver disease or
  • Multiple sclerosis, history of or
  • Psoriasis (skin disease) or
  • Seizures (convulsions), history of—Use with caution. May make these conditions worse.
  • Cancer, active or history of or
  • Chronic obstructive pulmonary disease (COPD)—Use with caution. May increase the chance of getting new cancers.
  • Heart disease or
  • Heart failure (congestive heart failure) or
  • Infection, active or
  • Tuberculosis, active—Should not be used in patients with these conditions.
  • Tuberculosis, history of—Use with caution. Patients may need additional tuberculosis therapy.

Proper Use of Remicade

A nurse or other trained health professional will give you or your child this medicine. Infliximab is given through a needle that is placed in one of your veins. This medicine needs to be given slowly. The needle will need to remain in place for at least 2 hours.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using Remicade

It is important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are using infliximab. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you or your child have any of the following symptoms while receiving this medicine: fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Serious skin reactions can occur while you are using this medicine. Check with your doctor right away if you or your child have any of the following symptoms while receiving this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness.

This medicine may increase your chance of having a lupus-like syndrome or a liver disease called autoimmune hepatitis. Check with your doctor right away if you or your child have fever or chills; a general feeling of discomfort, illness, or weakness; joint pain; light-colored stools; nausea and vomiting; a rash on the cheeks or arms that is worse in the sun; upper right stomach pain; or yellow eyes and skin.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. This is more common in patients who have lung diseases (emphysema, COPD) or are heavy smokers, and in psoriasis patients who have had phototherapy treatment for a long time. Phototherapy treatment is ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn's disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

While you are being treated with infliximab, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given to patients who are using infliximab. Your child's vaccinations need to be current before he or she begins using infliximab. Be sure to ask your child's doctor if you have any questions about this.

Check with your doctor right away if you or your child have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

It is important to have your heart checked closely if you take infliximab. Call your doctor right away if you have shortness of breath, swelling in the ankles and feet, or a sudden weight gain.

Do not take other medicines unless they have been discussed with your doctor. This includes anakinra (Kineret®) or etanercept (Enbrel®). Using these medicines together with infliximab may increase your chance of having serious side effects.

Do not change or stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Remicade Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain
  • chest pain
  • chills
  • cough
  • dizziness
  • fainting
  • fever
  • flushing of the face
  • headache
  • hives
  • itching
  • muscle pain
  • nasal congestion
  • nausea
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Less common
  • Back pain
  • bloody or cloudy urine
  • cracks in the skin at the corners of mouth
  • diarrhea
  • difficult or painful urination
  • frequent urge to urinate
  • high blood pressure
  • low blood pressure
  • pain
  • pain or tenderness around the eyes and cheekbones
  • skin rash
  • soreness or irritation of the mouth or tongue
  • soreness or redness around the fingernails or toenails
  • vaginal burning or itching and discharge
  • white patches in the mouth and/or on the tongue
  • Abscess (swollen, red, tender area of infection containing pus)
  • back or side pain
  • black, tarry stools
  • blood in the urine or stools
  • bone or joint pain
  • constipation
  • falls
  • feeling of fullness
  • general feeling of illness
  • hernia (bulge of tissue through the wall of the abdomen)
  • infection
  • irregular or pounding heartbeat
  • pain in the rectum
  • pain spreading from the abdomen to the left shoulder
  • pinpoint red spots on the skin
  • stomach pain (severe)
  • swollen or painful glands
  • tendon injury
  • unusual bleeding or bruising
  • weight loss (unusual)
  • yellow skin and eyes
Incidence not known
  • Area rash
  • bloody nose
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • change in mental status
  • clay-colored stools
  • continuing vomiting
  • convulsions
  • dark or bloody urine
  • difficulty with breathing
  • difficulty with speaking
  • difficulty with swallowing
  • fast heartbeat
  • general feeling of tiredness or weakness
  • heavier menstrual periods
  • hives
  • hoarseness
  • inability to move the arms and legs
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • lower back or side pain
  • muscle spasm or jerking of all extremities
  • noisy breathing
  • painful or difficult urination
  • painless swelling in the neck, armpits, or groin
  • pale skin
  • red, scaling, or crusted skin
  • redness, soreness, or itching skin
  • seizures
  • sensation of pins and needles
  • severe abdominal pain
  • severe muscle weakness, sudden and progressing
  • slow or irregular breathing
  • sore throat
  • sores, welting, or blisters
  • stabbing pain
  • sudden loss of consciousness
  • sudden numbness and weakness in the arms and legs
  • ulcers, sores, or white spots in the mouth
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Remicade Prescribing Information (FDA)
  • Remicade MedFacts Consumer Leaflet (Wolters Kluwer)
  • Remicade Consumer Overview
  • Infliximab Professional Patient Advice (Wolters Kluwer)

See Also...