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Adalimumab-Bwwd: uses, dosing, side effects & brands

Adalimumab-Bwwd is a medicine sold in the U.S. under one brand, for juvenile arthritis, rheumatoid arthritis and ulcerative colitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Juvenile Arthritis, Rheumatoid Arthritis and Ulcerative Colitis
Available as
Solution
Sold as
Hadlima
Prescription?
Prescription only
Generic available?
Not in our catalog
Boxed warning
Boxed warning

How adalimumab-bwwd is dosed

From the FDA label for Hadlima (application BLA761059). Other adalimumab-bwwd products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): • Adults: 40 mg every other week. • Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): • Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. • Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis ( 2.4 ): • Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). Plaque Psoriasis or Adult Uveitis ( 2.5 ): • Adults: 80 mg…

Adalimumab-Bwwd side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Malignancies [see Warnings and Precautions ( 5.2 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] • Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 )] • Neurologic Reactions [see Warnings and Precautions ( 5.5 )] • Hematological Reactions [see Warnings and Precautions ( 5.6 )] • Heart Failure [see Warnings and Precautions ( 5.8 )] • Autoimmunity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>10%): infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with adalimumab was injection site reactions. In placebo- controlled trials, 20% of patients treated with adalimumab developed injection site reactions (erythema and/or itching,…

Who shouldn’t take adalimumab-bwwd

None. None ( 4 )

Adalimumab-Bwwd drug interactions

Abatacept: Increased risk of serious infection ( 5.1 , 5.11 , 7.2 ) • Anakinra: Increased risk of serious infection ( 5.1 , 5.7 , 7.2 ) • Live vaccines: Avoid use with HADLIMA ( 5.10 , 7.3 ) * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of HADLIMA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either HADLIMA or MTX [see Clinical Pharmacology ( 12.3 )] . 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 HADLIMA with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of HADLIMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, Ps, HS and UV. Concomitant administration of HADLIMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. 7.3 Live Vaccines Avoid the use of live vaccines with HADLIMA [see Warnings and Precautions ( 5.10 )] . 7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for products that antagonize cytokine activity, such as adalimumab products, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of HADLIMA 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.

Every adalimumab-bwwd product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Hadlima.

Adalimumab-Bwwd recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long adalimumab-bwwd keeps

No adalimumab-bwwd label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does adalimumab-bwwd expire? The in-use limits and storage rules from its labels

What people report to the FDA about adalimumab-bwwd

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 19 reports naming adalimumab-bwwd, and the FDA flagged 47% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • headache4 reports
  • dyspnoea3 reports
  • injection site pain3 reports
  • rash pruritic3 reports
  • drug hypersensitivity2 reports
  • dysstasia2 reports
  • fluid retention2 reports
  • oxygen consumption increased2 reports

Read these as a signal, not a rate. A report does not mean adalimumab-bwwd caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is adalimumab-bwwd?

Hadlima (Adalimumab-Bwwd) is a medication used to treat Juvenile Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease.

Can you take adalimumab-bwwd with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run adalimumab-bwwd against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does adalimumab-bwwd come in?

Across the brands we track, adalimumab-bwwd is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic adalimumab-bwwd?

We do not currently list a generic-labelled adalimumab-bwwd product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has adalimumab-bwwd been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions adalimumab-bwwd. The most recent: HADLIMA (adalimumab-bwwd) injection (Oct 10, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page
APA
pharmaranks. (2026, July 24). Adalimumab-Bwwd: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/adalimumab-bwwd
MLA
“Adalimumab-Bwwd: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/adalimumab-bwwd.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for adalimumab-bwwd on DailyMed (NIH) ↗ — including its boxed warning in full.