KETOCONAZOLE TABLETS IN NIGERIA: WHAT YOU SHOULD KNOW

Author: Dr. Weriwoyingipre Silver Yeibake

On 8 July 2024, NAFDAC published a directive titled “Regulatory Directive on Discontinued Registration of Ketoconazole tablet.” In simple terms, the agency stopped the normal registration process for ketoconazole tablets.

This wording is more precise than saying that ketoconazole was “banned.” It does not automatically mean that NAFDAC declared every tablet already in circulation illegal. It also does not mean that anyone who has taken one tablet will definitely become ill. 

Because oral ketoconazole can cause serious liver injury, do not buy or use the tablets casually. Ask a doctor or pharmacist about an appropriate alternative. [3-5]

What discontinued registration means

“Discontinued registration” means that NAFDAC stopped the product’s normal registration process. Use the full directive—not just its title on NAFDAC’s regulatory index—to determine the directive’s exact operational effect. 

NAFDAC uses separate regulatory categories for withdrawal, suspension, and cancellation. Each category has a different meaning, and the legal effect depends on the action NAFDAC took and the product it listed. Do not cite the NAFDAC definitions page as proof that NAFDAC withdrew, suspended, or cancelled ketoconazole tablets unless the relevant product listing says so. 

Why it matters

Oral ketoconazole can cause serious liver injury. In rare cases, the injury can lead to liver failure, liver transplantation, or death. NAFDAC reports that serious injury has occurred after both high doses taken for short periods and lower doses taken for longer periods. Some affected patients had no obvious previous risk factors for liver disease. 

The U.S. Food and Drug Administration warns that oral ketoconazole can cause serious liver damage, adrenal-gland problems, and harmful interactions with other medicines. The FDA advises against using the tablets as a first-choice treatment for skin and nail fungal infections. 

The European Medicines Agency also concluded that oral ketoconazole’s risks outweighed its benefits for treating fungal infections when compared with alternative antifungal medicines. 

Taking one tablet does not automatically mean that poisoning has occurred. However, do not use oral ketoconazole without proper medical advice.

What products does the directive cover?

The NAFDAC directive specifically concerns *ketoconazole tablets*. Creams and shampoos are different dosage forms. They have different routes of use, indications, and regulatory records.

Do not describe the tablet directive as a ban on ketoconazole creams or shampoos without checking each product separately in NAFDAC’s Greenbook. 

What patients should do

- Do not start oral ketoconazole without speaking to a doctor or pharmacist.

- If you already have the tablets, ask a healthcare professional whether you should stop and what alternative to use.

- Do not stop other essential medicines because of this announcement.

- Do not buy oral ketoconazole from informal or unverified sources.

- Seek urgent medical care if you develop yellow eyes or skin, dark urine, pale stools, persistent nausea or vomiting, unusual tiredness, loss of appetite, abdominal pain, or confusion. [3-5]

Report suspected adverse reactions or product-quality problems to NAFDAC through the nearest NAFDAC office, by email at *pharmacovigilance@nafdac.gov.ng*, through NAFDAC’s electronic reporting platforms, or through the Med Safety application. 

What healthcare professionals should do

Doctors should avoid routine use of oral ketoconazole for uncomplicated fungal infections and consider suitable alternatives. 

If a doctor considers oral ketoconazole for a serious infection, the doctor should assess:

- Whether the diagnosis is correct.

- Whether a safer alternative is available.

- The patient’s liver health.

- The patient’s other medicines.

- Possible drug interactions.

- Whether the patient can receive appropriate monitoring.

Pharmacists and medicine sellers should not recommend oral ketoconazole casually. They should verify the product’s regulatory status, explain the risk of liver injury, and report suspected adverse reactions or poor-quality products to NAFDAC. 

What about creams and shampoos?

Do not assume that the tablet directive applies to topical ketoconazole products. Creams and shampoos have separate product records and different uses.

Check the specific cream or shampoo in NAFDAC’s Greenbook before making a regulatory claim. The Greenbook homepage can guide a search, but only a product-specific record can confirm a particular product’s status. 

Public-health message

> On 8 July 2024, NAFDAC published a directive discontinuing the registration process for ketoconazole tablets in Nigeria. This is not automatically a blanket ban on all ketoconazole products. However, oral ketoconazole can cause serious liver injury, so do not buy or use the tablets casually. Ask a healthcare professional about appropriate alternatives. Ketoconazole creams and shampoos are different products and require separate verification.

References

1. National Agency for Food and Drug Administration and Control. *Regulatory directives [Internet]. Abuja: NAFDAC; 2024 Jul 8 [cited 2026 Aug 13]. Available from: https://nafdac.gov.ng/regulatory-resources/regulatory-directive/  

 The page lists “Regulatory Directive on Discontinued Registration of Ketoconazole tablet” dated 8 July 2024. Use the direct directive document if a verified direct URL is available.*

2. National Agency for Food and Drug Administration and Control. *List of approval product withdrawals, suspensions and cancelations [Internet]. Abuja: NAFDAC; 2026 Mar 30. Available from: https://nafdac.gov.ng/list-of-approval-product-withdrawals-suspensions-cancellations/  

Supports NAFDAC’s distinctions among withdrawal, suspension, and cancellation. It should not be cited as proof that ketoconazole tablets were withdrawn, suspended, or cancelled.

3. U.S. Food and Drug Administration. FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses, including skin and nail fungal infections, continues [Internet]. Silver Spring (MD): FDA; 2016 May 19. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-prescribing-nizoral-ketoconazole-  

Supports the risks of serious liver damage, adrenal-gland problems, drug interactions, and the advice against routine use for skin and nail fungal infections.

4. U.S. Food and Drug Administration. Nizoral (ketoconazole) tablets: prescribing information [Internet]. Silver Spring (MD): FDA; 2014. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf  

Supports reports of serious hepatotoxicity, including cases requiring transplantation or resulting in death.

5. National Agency for Food and Drug Administration and Control. Rwanda recalls ketoconazole oral tablets over safety concerns [Internet]. Abuja: NAFDAC; 2025 May 27. Available from: https://nafdac.gov.ng/rwanda-recalls-ketoconazole-oral-tablets-over-safety-concerns/  

Supports the Nigerian safety information, warning symptoms, and NAFDAC pharmacovigilance reporting channels.

6. European Medicines Agency. Ketoconazole-containing medicinal products for systemic use: Article 31 referral—assessment report* [Internet]. Amsterdam: EMA; 2013. Available from: https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-assessment-report_en.pdf  

Supports the unfavourable benefit-risk assessment of oral ketoconazole for fungal infections.

7. National Agency for Food and Drug Administration and Control. *Greenbook: registered medicines and product information [Internet]. Abuja: NAFDAC. Available from: https://admin.greenbook.nafdac.gov.ng/  

 Use this database to verify the status of a specific topical ketoconazole product; the general homepage alone does not prove that every cream or shampoo is registered.*