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Xeljanz 5 mg Tablets

NAFDAC Reg. No. B4-7139 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Xeljanz 5 mg Tablets
NAFDAC number
B4-7139
Active ingredient
Tofacitinib
Strength
5 mg
Form
Tablet
Pack size
60's (in HDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Pfizer Specialties Ltd
Approved
26 Jan 2023
Status
Active View on NAFDAC ↗
Registration valid to
25 Jan 2028
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Xeljanz 5 mg Tablets is on the NAFDAC register with an active registration (B4-7139). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Xeljanz 5 mg Tablets is used for

From the official U.S. FDA label for tofacitinib, the active ingredient registered with NAFDAC.

Boxed warning: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib extended-release tablets are at increased risk for developing serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. …
What it is used for

Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Increased Risk of Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are: RA, PsA, and AS: Reported in ≥2% of …

Do not use if

None. None ( 4 )

Warnings

Serious Infections: Avoid use of tofacitinib extended-release tablets during an active serious infection, including localized infections. ( 5.1 ) Gastrointestinal Perforations: Promptly evaluate patients at increased risk for gastrointestinal perforation who present with new onset abdominal symptoms. ( 5.6 ) Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. ( 5.8 ) Vaccinations: Avoid use of live vaccines concurrently with tofacitinib extended-release tablets ( 5.9 ) 5.1 Serious Infections Serious and sometimes fatal infections may occur with tofacitinib extended-release tablets. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary The available data with tofacitinib extended-release tablets from a pregnancy exposure registry that enrolled exposed pregnant females, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Xeljanz 5 mg Tablets

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Xeljanz 5 mg Tablets

What is in Xeljanz 5 mg Tablets?

Xeljanz 5 mg Tablets contains Tofacitinib (5 mg), as tablet, according to its NAFDAC registration record.

Is Xeljanz 5 mg Tablets registered with NAFDAC?

Yes. Xeljanz 5 mg Tablets is listed on the NAFDAC register under registration number B4-7139, and its registration is active as of 27 October 2026.

Has Xeljanz 5 mg Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Xeljanz 5 mg Tablets in our automatically synced alert list.

How can I check that my pack of Xeljanz 5 mg Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-7139, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Xeljanz 5 mg Tablets used for?

Tofacitinib extended-release tablets are Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or mor (Summarised from the official U.S. FDA label for tofacitinib. Always follow your doctor or pharmacist.)

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