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Zoloft 50 mg Capsules

NAFDAC Reg. No. 04-2796 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Zoloft 50 mg Capsules
NAFDAC number
04-2796
Active ingredient
Sertraline (Sertraline hydrochloride)
Strength
50 mg
Form
Capsule
Manufacturer
Not listed
Applicant (holder)
Pfizer Specialties Ltd
Approved
30 Nov 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
29 Nov 2025
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Zoloft 50 mg Capsules is on the NAFDAC register with an active registration (04-2796). 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 Zoloft 50 mg Capsules is used for

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

Boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ See Warnings and Precautions ( 5.1 ) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. …
What it is used for

Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies ( 14 ) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)

Possible side effects

The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications ( 4 )] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications ( 4 ) , Clinical Pharmacology ( 12.2 )] Suicidal thoughts and behaviors [See Warnings and Precautions ( 5.1 )] Serotonin syndrome [See Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] Increased risk of bleeding [See Warnings and Precautions ( 5.3 )] Activation of mania/hypomania [See Warnings and Precautions ( 5.4) ] Discontinuation syndrome [See Warnings and Precautions ( 5.5 )] Seizu …

Do not use if

Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [ See Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 ) ]. Taking pimozide [ See Drug Interactions ( 7.1 ) ]. With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [ See Adverse Reactions ( 6.1 , 6.2 ) ]. …

Warnings

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline hydrochloride and serotonergic agents and initiate supportive treatment. ( 5.2 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. ( 5.3 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Seizures: Use with caution in patients with seizure disorders. …

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 should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. …

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

Check your pack of Zoloft 50 mg 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 Zoloft 50 mg Capsules

What is in Zoloft 50 mg Capsules?

Zoloft 50 mg Capsules contains Sertraline (Sertraline hydrochloride) (50 mg), as capsule, according to its NAFDAC registration record.

Is Zoloft 50 mg Capsules registered with NAFDAC?

Yes. Zoloft 50 mg Capsules is listed on the NAFDAC register under registration number 04-2796, and its registration is active as of 5 November 2026.

Has Zoloft 50 mg Capsules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Zoloft 50 mg Capsules in our automatically synced alert list.

How can I check that my pack of Zoloft 50 mg Capsules is genuine?

Run a free authenticity scan with the NAFDAC number 04-2796, 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 Zoloft 50 mg Capsules used for?

Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies ( 14 ) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor ( (Summarised from the official U.S. FDA label for sertraline (sertraline hydrochloride). Always follow your doctor or pharmacist.)

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