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Xytal-50 Tablets

NAFDAC Reg. No. C4-1509 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Xytal-50 Tablets
NAFDAC number
C4-1509
Active ingredient
Quetiapine (Quetiapine Fumarate)
Strength
50 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Pharmacy Plus Ltd
Approved
21 Dec 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
20 Dec 2025
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Xytal-50 Tablets is on the NAFDAC register with an active registration (C4-1509). 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 Xytal-50 Tablets is used for

From the official U.S. FDA label for quetiapine (quetiapine fumarate), the active ingredient registered with NAFDAC.

Boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [ see Warnings and Precautions (5.1) ]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. …
What it is used for

Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.1) ]. …

Possible side effects

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4 )] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5 )] Tardive dyskinesia [see Warnings and Precautions (5.6 )] Hypotension [see Wa …

Do not use if

Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine. Known hypersensitivity to quetiapine or any components in the formulation. ( 4 )

Warnings

· Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( 5.3 ) · Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring ( 5.4 ) · Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5 ) · Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine tablets, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . …

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

Check your pack of Xytal-50 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 Xytal-50 Tablets

What is in Xytal-50 Tablets?

Xytal-50 Tablets contains Quetiapine (Quetiapine Fumarate) (50 mg), as tablet, according to its NAFDAC registration record.

Is Xytal-50 Tablets registered with NAFDAC?

Yes. Xytal-50 Tablets is listed on the NAFDAC register under registration number C4-1509, and its registration is active as of 27 October 2026.

Has Xytal-50 Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Xytal-50 Tablets in our automatically synced alert list.

How can I check that my pack of Xytal-50 Tablets is genuine?

Run a free authenticity scan with the NAFDAC number C4-1509, 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 Xytal-50 Tablets used for?

Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 y (Summarised from the official U.S. FDA label for quetiapine (quetiapine fumarate). Always follow your doctor or pharmacist.)

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