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Seroxetine 20 Capsules

NAFDAC Reg. No. B4-4818 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Seroxetine 20 Capsules
NAFDAC number
B4-4818
Active ingredient
Fluoxetine (Fluoxetine Hydrochloride)
Strength
20 mg
Form
Capsule
Pack size
10 x 10's
Manufacturer
Not listed
Applicant (holder)
Dony-Triumph and Company Nigeria Limited
Approved
7 May 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
6 May 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Seroxetine 20 Capsules is on the NAFDAC register with an active registration (B4-4818). 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 Seroxetine 20 Capsules is used for

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

Boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. …
What it is used for

Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2 )]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3 )]. • Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4 ) ]. …

Possible side effects

The following adverse reactions are discussed in more detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [ see Boxed Warning and Warnings and Precautions (5.1)] • Serotonin Syndrome [ see Warnings and Precautions (5.2)] • Allergic Reactions and Rash [ see Warnings and Precautions (5.3) ] • Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [ see Warnings and Precautions (5.4)] • Seizures [ see Warnings and Precautions (5.5)] • Altered Appetite and Weight [ see Warnings and Precautions (5.6)] • Increased Risk of Bleeding [ see Warnings and Precautions (5.7)] • Angle-Closure Glaucoma [ see Warnings and …

Do not use if

When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. …

Warnings

When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior ( 5.1 ) • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including fluoxetine, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluoxetine and serotonergic agents and initiate supportive treatment. …

Pregnancy & breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. …

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

Check your pack of Seroxetine 20 Capsules

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 Seroxetine 20 Capsules

What is in Seroxetine 20 Capsules?

Seroxetine 20 Capsules contains Fluoxetine (Fluoxetine Hydrochloride) (20 mg), as capsule, according to its NAFDAC registration record.

Is Seroxetine 20 Capsules registered with NAFDAC?

Yes. Seroxetine 20 Capsules is listed on the NAFDAC register under registration number B4-4818, and its registration is active as of 5 November 2026.

Has Seroxetine 20 Capsules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Seroxetine 20 Capsules in our automatically synced alert list.

How can I check that my pack of Seroxetine 20 Capsules is genuine?

Run a free authenticity scan with the NAFDAC number B4-4818, 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 Seroxetine 20 Capsules used for?

Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2 )]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate (Summarised from the official U.S. FDA label for fluoxetine (fluoxetine hydrochloride). Always follow your doctor or pharmacist.)

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