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Masrone Tablets

NAFDAC Reg. No. A4-100732 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Masrone Tablets
NAFDAC number
A4-100732
Active ingredient
Risperidone
Strength
2 mg
Form
Tablet
Pack size
3 x 10's (in blisters)
Manufacturer
Not listed
Applicant (holder)
Micro Nova Pharmaceuticals Ind Ltd
Approved
31 Jan 2024
Status
Active View on NAFDAC ↗
Registration valid to
30 Jan 2029
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Masrone Tablets is on the NAFDAC register with an active registration (A4-100732). 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 Masrone Tablets is used for

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

Boxed warning: 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. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis. …
What it is used for

Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . …

Possible side effects

The following are discussed in more detail in other sections of the labeling: • Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions ( 5.2 )] • Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] • Tardive dyskinesia [see Warnings and Precautions ( 5.4 )] • Metabolic Changes (Hyperglycemia and diabetes mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions ( 5.5 )] • Hyperprolactinemia [see Warnings and Precautions ( 5.6 )] • Orthostatic hypotension [s …

Do not use if

Risperidone tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone tablets formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. …

Warnings

Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone tablets are not approved for use in patients with dementia-related psychosis ( 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of risperidone tablets and close monitoring. ( 5.3 ) Tardive dyskinesia: Consider discontinuing risperidone tablets if clinically indicated. ( 5.4 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular / cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. …

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 risperidone, 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 Masrone 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 Masrone Tablets

What is in Masrone Tablets?

Masrone Tablets contains Risperidone (2 mg), as tablet, according to its NAFDAC registration record.

Is Masrone Tablets registered with NAFDAC?

Yes. Masrone Tablets is listed on the NAFDAC register under registration number A4-100732, and its registration is active as of 28 October 2026.

Has Masrone Tablets been flagged as fake or recalled?

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

How can I check that my pack of Masrone Tablets is genuine?

Run a free authenticity scan with the NAFDAC number A4-100732, 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 Masrone Tablets used for?

Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of s (Summarised from the official U.S. FDA label for risperidone. Always follow your doctor or pharmacist.)

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