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infliximab

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Brand names: Remicade

TNF-Alpha Inhibitor (Biologic) Rx

Inflectra is a medicine that blocks a protein called TNF. It is used to treat autoimmune diseases and reduce inflammation.

Drug Pricing (NADAC)

Brand Price

$1135.97/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Inflectra treats Crohn's disease in adults and children (6+).

Common side effects

Infections (like colds, sinus infections, and sore throat), Infusion-related reactions, Headache

Key warnings

Inflectra can increase your risk of serious infections that may lead to hospitalization or death.

How It Works

Inflectra blocks a protein in your body called tumor necrosis factor (TNF). TNF can cause inflammation and damage in autoimmune diseases. By blocking TNF, Inflectra can reduce inflammation and improve symptoms.

How to Take It

Inflectra is given through a needle into your vein (IV infusion). The infusion takes at least 2 hours. For Crohn's disease and ulcerative colitis, you'll likely get 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. For rheumatoid arthritis, the dose is 3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks, along with methotrexate.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Inflectra can pass to your baby during pregnancy, mainly in the third trimester. Live vaccines are not recommended for at least 6 months after birth for babies exposed to Inflectra in the womb.

Missed Dose

Call your doctor right away if you miss an Inflectra infusion appointment. They will tell you when to schedule your next infusion.

Storage

Store unopened Inflectra vials in the refrigerator between 36°F to 46°F (2°C to 8°C).

Side Effects (from patient reports)

Based on 208,059 FDA adverse event reports.

The medicine is not working
38,909
Using the medicine for a condition it is not approved for
36,963
Reaction during or shortly after the infusion
18,647
Condition got worse
18,302
Rheumatoid arthritis
18,137
Pain
18,108
Joint pain
16,852
Tiredness
16,116
Problem with how the medicine is used
13,140
Skin rash
12,885

FDA Adverse Event Report Analysis

Detailed analysis of 211,136 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.

Total Reports

211,136

Death-Related Reports

12,983

Hospitalization Reports

62,267

Top Indication

Rheumatoid Arthritis

Gender Distribution

Female 116,766 (63%)
Male 67,683 (37%)

Age Distribution

0–17 16,424
18–44 42,296
45–64 40,808
65–74 14,719
75+ 6,015

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 38,908
2 OFF LABEL USE 36,963
3 INFUSION RELATED REACTION 18,648
4 CONDITION AGGRAVATED 18,301
5 RHEUMATOID ARTHRITIS 18,136
6 PAIN 18,107
7 ARTHRALGIA 16,853
8 FATIGUE 16,118
9 PRODUCT USE ISSUE 13,140
10 RASH 12,886
11 DRUG INTOLERANCE 12,164
12 NAUSEA 11,872
13 INTENTIONAL PRODUCT USE ISSUE 11,628
14 ALOPECIA 11,587
15 JOINT SWELLING 11,306

Reactions in Death Reports

OFF LABEL USE 2,839
DEATH 2,334
JOINT SWELLING 2,149
INFUSION RELATED REACTION 2,141
FATIGUE 2,109
RHEUMATOID ARTHRITIS 2,104
HYPERTENSION 2,102
GENERAL PHYSICAL HEALTH DETERIORATION 2,067
GLOSSODYNIA 2,042
HEPATIC ENZYME INCREASED 2,038

Reactions in Hospitalization Reports

OFF LABEL USE 10,372
DRUG INEFFECTIVE 8,981
CONDITION AGGRAVATED 6,209
INFUSION RELATED REACTION 5,806
ARTHRALGIA 5,666
PAIN 5,511
FATIGUE 5,020
RHEUMATOID ARTHRITIS 4,834
NAUSEA 4,762
PYREXIA 4,712

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Inflectra can increase your risk of serious infections that may lead to hospitalization or death. Tell your doctor if you have any infection symptoms. You should be tested for tuberculosis (TB) before starting Inflectra. Some people, especially children and young adults, have developed cancers like lymphoma while taking TNF blockers. Some of these cancers have been fatal.

Known Drug Interactions

moderate abatacept

An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. Because of the nature of the adverse reactions seen with these combinations with TNF blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNF blockers. Therefore, the combination of INFLECTRA and anakinra or abatacept is not recommended [see Warnings and Precautions (5.10) ] .

Mechanism: Both drugs weaken the immune system, which makes it much harder for the body to fight off serious infections. Using them together does not provide any extra health benefits.

What to do: This combination is not recommended. Your doctor should avoid prescribing these two medications at the same time to prevent dangerous infections.

In RA, concomitant medications besides MTX were nonsteroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids and/or narcotics. In PsA clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids.

Mechanism: There is no known negative interaction between these two drugs, and they are frequently used together to manage rheumatoid arthritis.

What to do: It is generally safe to take these medications together as directed by your doctor.

Upon initiation or discontinuation of INFLECTRA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

Mechanism: Infliximab can change how the liver breaks down other drugs like warfarin. This can cause the amount of warfarin in your body to change when you start or stop treatment.

What to do: Your doctor should monitor your blood clotting levels closely and may need to adjust your warfarin dose.

7.2 Methotrexate and Other Concomitant Medications Specific drug interaction studies, including interactions with methotrexate (MTX), have not been conducted.

Mechanism: There is no specific information available on how these two drugs interact because clinical studies have not been performed.

What to do: Talk to your doctor about using these together, as the exact effects of the combination are not fully known.

Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of CD including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates.

Mechanism: This antibiotic does not appear to change the amount of infliximab that stays in your blood.

What to do: No special changes are usually needed when taking these two drugs at the same time.

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Common Questions

What should I tell my doctor before starting Inflectra?
Tell your doctor about all your medical conditions, including any infections, heart problems, or nervous system disorders.
Can I get vaccines while taking Inflectra?
Do not get live vaccines while taking Inflectra. Talk to your doctor before getting any vaccines.
What are the signs of an infusion reaction?
Signs of an infusion reaction include fever, chills, chest pain, low or high blood pressure, and trouble breathing.
What should I do if I have an infection?
Tell your doctor right away if you have any signs of infection, such as fever, cough, or body aches.
Can Inflectra affect my heart?
Inflectra can cause new or worsening heart failure. Tell your doctor if you have any heart problems.
How often will I receive Inflectra?
The usual schedule is every 8 weeks after the first few doses, but your doctor will determine the best schedule for you.
Can Inflectra cause liver problems?
Inflectra can cause liver problems. Tell your doctor if you develop yellowing of the skin or eyes.
What if I am taking other medications?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How long will I need to take Inflectra?
Your doctor will decide how long you need to take Inflectra based on your condition and how well you respond to the medicine.
What if I have a history of hepatitis B?
Tell your doctor if you have or had hepatitis B. Inflectra can cause hepatitis B to become active again.
What are the common side effects of infliximab?
The most commonly reported side effects of infliximab include Infections (like colds, sinus infections, and sore throat), Infusion-related reactions, Headache, Abdominal pain. Based on 208,059 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does infliximab interact with other medications?
Yes, infliximab has 8 known drug interactions. Notable interactions include abatacept, folic acid, warfarin. Always inform your doctor about all medications you are taking.
What drug class is infliximab?
infliximab belongs to the TNF-Alpha Inhibitor (Biologic) drug class. It requires a prescription (Rx). Inflectra treats Crohn's disease in adults and children (6+).
Is infliximab safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Inflectra can pass to your baby during pregnancy, mainly in the third trimester. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in TNF-Alpha Inhibitor (Biologic)

Other drugs grouped near infliximab — same-class peers and common alternatives.

Compare infliximab vs abatacept side-by-side →

Medication Guides

Related Health & Safety Data

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What the FDA Data Shows for infliximab

The FDA label for infliximab (sold under brand names such as Remicade) classifies it as a prescription-only medication in the TNF-Alpha Inhibitor (Biologic) class. Inflectra treats Crohn's disease in adults and children (6+). Official labeling lists 4 commonly reported side effects, including Infections (like colds, sinus infections, and sore throat), Infusion-related reactions, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 208,059 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: September 10, 2025

All federal data sources used on this page