Remicade Powder For Solution For Injection 100Mg Drug Medication Dosage Information
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Remicade: Powder for solution for injection (100mg)

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What is this Medicine?

INFLIXIMAB (in FLIX i mab) is used to treat Crohn's disease and ulcerative colitis. It is also used to treat ankylosing spondylitis, plaque psoriasis, and some forms of arthritis.

In-Depth Information

Remicade 100mg Powder for Injection

NDC: 578940030
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis, Crohn's Disease

Sometimes used for but not FDA approved for the following conditions:
Behcet's Syndrome, Uveitis

Storage Information
Product stored at controlled room temperature should not be returned to a refrigerator
Prior to dispensing, store in refrigerator (36 to 46 degrees F)
May be stored at temperatures up to 86 degrees F for up to 6 months
Remicade 100mg Powder for Injection

Reported Side Effects for Remicade 100mg Powder for Injection

High Blood Pressure Incidence:
<7.0%*
Severity: MODERATE
Onset: EARLY
Anaphylactoid Reactions Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Muscle Pain Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Hives Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Enlarged Lymph Nodes Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Irritated Blood Vessels Incidence:
>0.2%*
Severity: MODERATE
Onset: RAPID
Low White Blood Cell Counts Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Lightheadedness Incidence:
>0.2%*
Severity: MILD
Onset: EARLY
Intestinal Blockage Incidence:
>0.2%*
Severity: SEVERE
Onset: DELAYED
Slow Heart Beat Incidence:
>0.2%*
Severity: SEVERE
Onset: RAPID
Low Platelet Count Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Serum Sickness Incidence:
0.2-1.0%*
Severity: SEVERE
Onset: DELAYED
Fluid In Lungs Incidence:
>0.2%*
Severity: SEVERE
Onset: EARLY
Dehydration Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
>0.2%*
Severity: MODERATE
Onset: DELAYED
Low Blood Pressure Incidence:
0.2-1.0%*
Severity: MODERATE
Onset: RAPID
Excessive Sweating Incidence:
>0.2%*
Severity: MILD
Onset: DELAYED
Hemolytic Anemia Incidence:
>0.2%*
Severity: SEVERE
Onset: DELAYED
Joint Pain Incidence:
1.0-8.0%*
Severity: MILD
Onset: DELAYED
Shortness Of Breath Incidence:
1.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
1.0%*
Severity: MODERATE
Onset: EARLY
Chills Incidence:
3.0%*
Severity: MILD
Onset: RAPID
Skin Rash Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
3.0-7.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
5.0-18.0%*
Severity: MILD
Onset: EARLY
Yeast Infection Incidence:
5.0%*
Severity: MODERATE
Onset: DELAYED
Infection Incidence:
5.3-56.0%*
Severity: MILD
Onset: DELAYED
Low White Blood Cells Incidence:
7.0%*
Severity: MODERATE
Onset: DELAYED
Antibody Formation Incidence:
7.0-62.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
9.0%*
Severity: MILD
Onset: EARLY
Flushing Incidence:
9.0%*
Severity: MILD
Onset: RAPID
Upset Stomach Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
12.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
12.0-26.0%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
14.0%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
17.0-51.0%*
Severity: MODERATE
Onset: DELAYED
Infusion-related Reactions Incidence:
18.0-20.0%*
Severity: MODERATE
Onset: RAPID
Upset Stomach Incidence:
21.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
First Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Second Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Third Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Compatible - This drug is generally safe to take by nursing mothers.


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