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Abacavir Tablets_

NAFDAC Reg. No. B4-3826 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Abacavir Tablets_
NAFDAC number
B4-3826
Active ingredient
Abacavir Sulfate
Strength
300 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Hetero Labs Nigeria Limited
Approved
10 Nov 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
9 Nov 2025
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Abacavir Tablets_ is on the NAFDAC register with an active registration (B4-3826). 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 Abacavir Tablets_ is used for

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

Boxed warning: HYPERSENSITIVITY REACTIONS Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions (5.1) ] . …
What it is used for

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

Possible side effects

The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning , Warnings and Precautions (5.1) ] . Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2) ] . Immune reconstitution syndrome [see Warnings and Precautions (5.3) ] . Myocardial infarction [see Warnings and Precautions (5.4) ] . The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. …

Do not use if

Abacavir tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1) ] . with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1) ]. with moderate or severe hepatic impairment [see Use in Specific Populations (8.6) ] . Presence of HLA-B*5701 allele. ( 4 ) Prior hypersensitivity reaction to abacavir. ( 4 ) Moderate or severe hepatic impairment. ( 4 )

Warnings

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.2 ) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions (6.1) ] . …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. …

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

Check your pack of Abacavir 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 Abacavir Tablets_

What is in Abacavir Tablets_?

Abacavir Tablets_ contains Abacavir Sulfate (300 mg), as tablet, according to its NAFDAC registration record.

Is Abacavir Tablets_ registered with NAFDAC?

Yes. Abacavir Tablets_ is listed on the NAFDAC register under registration number B4-3826, and its registration is active as of 27 October 2026.

Has Abacavir Tablets_ been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Abacavir Tablets_ in our automatically synced alert list.

How can I check that my pack of Abacavir Tablets_ is genuine?

Run a free authenticity scan with the NAFDAC number B4-3826, 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 Abacavir Tablets_ used for?

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 ) (Summarised from the official U.S. FDA label for abacavir sulfate. Always follow your doctor or pharmacist.)

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