Prescription medication · TNF-Alpha Inhibitor (Biologic)
adalimumab
Also sold as Humira. Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage.
Data updated 2026-05-15
- 695,825
- FDA reportsHeavily reported
- 5
- InteractionsFew interactions
- 1
- Recall record
What the data shows
adalimumab (Humira) is a prescription TNF-Alpha Inhibitor (Biologic), one of the most-reported medications in the FDA FAERS database (695,825 FDA reports), with 5 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.
adalimumab (Humira) is a prescription TNF-Alpha Inhibitor (Biologic). Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage.
Idacio is a medicine that blocks a protein called TNF. It is used to treat several diseases, including arthritis and Crohn's disease.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$3361.23/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage.
Common side effects
Infections (like colds or sinus infections), Injection site reactions (redness, itching, pain, or swelling), Headache
Key warnings
Idacio can increase your risk of serious infections that could lead to hospitalization or death.
The sections below are summarized in plain English from adalimumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Idacio works by blocking a protein in your body called tumor necrosis factor (TNF). TNF can cause inflammation and damage in certain diseases. By blocking TNF, Idacio can reduce these symptoms.
How to Take It
Idacio is given as a shot under the skin (subcutaneous injection). The dose and how often you get it depends on your condition. For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the usual dose is 40 mg every other week. Some people with rheumatoid arthritis may need 40 mg every week or 80 mg every other week.
This is a plain-language summary of adalimumab'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. Idacio can cross the placenta and may affect your baby's immune system. Talk to your doctor about vaccines for your baby if you took Idacio during pregnancy.
This is a plain-language summary of adalimumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of Idacio, inject it as soon as you remember. Then, take your next dose at your regular scheduled time.
This is a plain-language summary of adalimumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Idacio in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze and protect from light.
Side Effects (from patient reports)
Based on 695,825 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for adalimumab, by number of reports
- Pain
Pain
49,062 reports
- Joint pain
Joint pain
48,041 reports
- Pain at the injection site
Pain at the injection site
47,251 reports
- Tiredness
Tiredness
39,113 reports
- Rheumatoid arthritis
Rheumatoid arthritis
35,571 reports
- Headache
Headache
28,330 reports
- Feeling sick to your stomach
Feeling sick to your stomach
27,103 reports
- Diarrhea
Diarrhea
25,414 reports
- Rash
Rash
25,271 reports
- Psoriasis
Psoriasis
24,706 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 adalimumab 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 adalimumab sits
adalimumab has more FDA adverse-event reports than 100% 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 adalimumab; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 695,825 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
695,825
Reports Mentioning Death
28,962
4.2% of reports — not proof of cause
Hospitalization Reports
146,638
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | PAIN | 49,062 |
| 3 | ARTHRALGIA | 48,039 |
| 4 | INJECTION SITE PAIN | 47,251 |
| 5 | FATIGUE | 39,111 |
| 6 | RHEUMATOID ARTHRITIS | 35,573 |
| 7 | HEADACHE | 28,330 |
| 8 | NAUSEA | 27,102 |
| 9 | DIARRHOEA | 25,413 |
| 10 | RASH | 25,271 |
| 11 | PSORIASIS | 24,707 |
| 12 | PAIN IN EXTREMITY | 24,313 |
| 13 | JOINT SWELLING | 23,282 |
| 14 | INCORRECT DOSE ADMINISTERED | 22,332 |
| 15 | MALAISE | 21,339 |
| 17 | NASOPHARYNGITIS | 20,605 |
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
Idacio can increase your risk of serious infections that could lead to hospitalization or death. Tell your doctor if you have any infections before starting Idacio. Idacio may also increase your risk of certain cancers, including lymphoma. Children and teens taking TNF blockers like Idacio have developed rare, aggressive cancers.
Known Drug Interactions
7 DRUG INTERACTIONS • Abatacept: Increased risk of serious infection. 7.2 Biological Products In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of IDACIO with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . Concomitant administration of IDACIO with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk...
Mechanism: Both drugs lower your body's ability to fight germs. Taking them together increases your risk of getting a very serious infection without helping your symptoms more.
What to do: This combination is not recommended. Talk to your doctor about using a different treatment plan that only uses one of these drugs.
Upon initiation or discontinuation of IDACIO 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: Adalimumab can change how your body processes other drugs like warfarin, which could make the blood thinner more or less effective.
What to do: Your doctor should closely monitor your blood clotting levels and may need to adjust your warfarin dose when starting or stopping this medicine.
( 5.10 , 7.3 ) 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX).
Mechanism: These two drugs are often used together to treat joint pain, and methotrexate can help the body accept the other medicine better.
What to do: Your doctor will monitor your condition while you take both of these medications together.
Upon initiation or discontinuation of IDACIO 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: Adalimumab can change how your liver breaks down other medicines, which can cause the amount of cyclosporine in your blood to change.
What to do: Your doctor should check your blood levels of cyclosporine and may need to adjust your dose.
Upon initiation or discontinuation of IDACIO 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: This medicine can affect the way your body processes theophylline, which might lead to levels that are too high or too low.
What to do: Your doctor should monitor your theophylline blood levels and adjust your dose if needed.
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 if I have an infection?
Can Idacio cause cancer?
Can I take Idacio with other medicines?
Can I get vaccines while taking Idacio?
How will I know if Idacio is working?
What should I do if I have side effects?
How is Idacio given?
How often will I get Idacio?
What does Idacio look like?
What should I do before each injection?
What are the common side effects of adalimumab?
Does adalimumab interact with other medications?
What drug class is adalimumab?
Is adalimumab safe during pregnancy?
Has adalimumab been recalled?
Active Recalls
Lack of Assurance of Sterility.
Samsung Bioepis Co., Ltd.
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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 adalimumab
The FDA label for adalimumab (sold under brand names such as Humira) classifies it as a prescription-only medication in the TNF-Alpha Inhibitor (Biologic) class. Idacio can help adults with rheumatoid arthritis by reducing joint pain and damage. Official labeling lists 4 commonly reported side effects, including Infections (like colds or sinus infections), Injection site reactions (redness, itching, pain, or swelling), Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 695,825 voluntary reports. The database also lists 5 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 (currently 1 recall record on file), 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: October 15, 2024
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