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Hyxroxyurea 100mg Film Coated Tablet

NAFDAC Reg. No. A4-100407 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Hyxroxyurea 100mg Film Coated Tablet
NAFDAC number
A4-100407
Active ingredient
Hydroxycarbamide
Strength
100 mg
Form
Film coated tablet
Pack size
1 x 200's (in HDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
25 May 2023
Status
Active View on NAFDAC ↗
Registration valid to
24 May 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Hyxroxyurea 100mg Film Coated Tablet is on the NAFDAC register with an active registration (A4-100407). 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. Not medical advice — always follow your doctor or pharmacist.

What Hyxroxyurea 100mg Film Coated Tablet is used for

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

What it is used for

Hydroxyurea capsules, USP is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of: • Resistant chronic myeloid leukemia. (1) • Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)

Possible side effects

• Myelosuppression [see Warnings and Precautions (5.1) ] • Hemolytic anemia [see Warnings and Precautions (5.2) ] • Malignancies [see Warnings and Precautions (5.3) ] • Vasculitic toxicities [see Warnings and Precautions (5.5) ] • Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7) ] • Radiation recall [see Warnings and Precautions (5.8) ] • Macrocytosis [see Warnings and Precautions (5.9) ] • Pulmonary Toxicity [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. …

Do not use if

Hydroxyurea capsules is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. • In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. (4)

Warnings

Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary. (5.1) Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue Hydroxyurea. (5.2) Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. ( 5.3) Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) Vasculitic toxicities: Discontinue hydroxyurea and initiate treatment if this occurs. …

Pregnancy & breastfeeding

IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. (8.2) Geriatric Use: Care should be taken in dose selection and may require a lower dose regimen and monitoring of renal function. (8.5) 8.1 Pregnancy Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ]. …

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

Check your pack of Hyxroxyurea 100mg Film Coated Tablet

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Hyxroxyurea 100mg Film Coated Tablet

What is in Hyxroxyurea 100mg Film Coated Tablet?

Hyxroxyurea 100mg Film Coated Tablet contains Hydroxycarbamide (100 mg), as film coated tablet, according to its NAFDAC registration record.

Is Hyxroxyurea 100mg Film Coated Tablet registered with NAFDAC?

Yes. Hyxroxyurea 100mg Film Coated Tablet is listed on the NAFDAC register under registration number A4-100407, and its registration is active as of 5 November 2026.

Has Hyxroxyurea 100mg Film Coated Tablet been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Hyxroxyurea 100mg Film Coated Tablet in our automatically synced alert list.

How can I check that my pack of Hyxroxyurea 100mg Film Coated Tablet is genuine?

Run a free authenticity scan with the NAFDAC number A4-100407, 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 Hyxroxyurea 100mg Film Coated Tablet used for?

Hydroxyurea capsules, USP is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of: • Resistant chronic myeloid leukemia. (1) • Locally advanced squamous cell carcinomas of the head and nec (Summarised from the official U.S. FDA label for hydroxycarbamide. Always follow your doctor or pharmacist.)

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