Prescription medication · TNF-Alpha Inhibitor (Biologic)
infliximab
Also sold as Remicade. Inflectra treats Crohn's disease in adults and children (6+).
Data updated 2026-05-15
- 211,136
- FDA reportsHeavily reported
- 8
- InteractionsFew interactions
- $1135.97
- Brand price (NADAC)
What the data shows
infliximab (Remicade) is a prescription TNF-Alpha Inhibitor (Biologic), in the top 5% of tracked drugs by FAERS report volume (211,136 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
infliximab (Remicade) is a prescription TNF-Alpha Inhibitor (Biologic). Inflectra treats Crohn's disease in adults and children (6+).
Inflectra is a medicine that blocks a protein called TNF. It is used to treat autoimmune diseases and reduce inflammation.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from infliximab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of infliximab's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of infliximab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Call your doctor right away if you miss an Inflectra infusion appointment. They will tell you when to schedule your next infusion.
This is a plain-language summary of infliximab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 211,136 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for infliximab, by number of reports
- Reaction during or shortly after the infusion
Reaction during or shortly after the infusion
18,647 reports
- Condition got worse
Condition got worse
18,302 reports
- Rheumatoid arthritis
Rheumatoid arthritis
18,137 reports
- Pain
Pain
18,108 reports
- Joint pain
Joint pain
16,852 reports
- Tiredness
Tiredness
16,116 reports
- Skin rash
Skin rash
12,885 reports
- Feeling sick to your stomach
Feeling sick to your stomach
11,874 reports
- Hair loss
Hair loss
11,587 reports
- Swollen joint
Swollen joint
11,306 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for infliximab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where infliximab sits
infliximab has more FDA adverse-event reports than 95% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is infliximab; the line is the median (50th percentile).
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
Reports Mentioning Death
12,983
6.1% of reports — not proof of cause
Hospitalization Reports
62,267
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 10 | RASH | 12,886 |
| 12 | NAUSEA | 11,872 |
| 14 | ALOPECIA | 11,587 |
| 15 | JOINT SWELLING | 11,306 |
| 16 | HEADACHE | 10,769 |
| 17 | SYSTEMIC LUPUS ERYTHEMATOSUS | 10,427 |
| 18 | ABDOMINAL DISCOMFORT | 10,421 |
| 19 | DIARRHOEA | 10,323 |
| 20 | DYSPNOEA | 10,215 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I tell my doctor before starting Inflectra?
Can I get vaccines while taking Inflectra?
What are the signs of an infusion reaction?
What should I do if I have an infection?
Can Inflectra affect my heart?
How often will I receive Inflectra?
Can Inflectra cause liver problems?
What if I am taking other medications?
How long will I need to take Inflectra?
What if I have a history of hepatitis B?
What are the common side effects of infliximab?
Does infliximab interact with other medications?
What drug class is infliximab?
Is infliximab safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 211,136 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages