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Amitryptylline HCl Tablets

NAFDAC Reg. No. B4-3798 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Amitryptylline HCl Tablets
NAFDAC number
B4-3798
Active ingredient
Amitriptyline Hydrochloride
Strength
25 mg
Form
Tablet
Pack size
1 x 500's; 1 x 1000's
Manufacturer
Not listed
Applicant (holder)
Manfes Pharmaceutical Company Limited
Approved
26 Aug 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
25 Aug 2026
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Amitryptylline HCl Tablets is on the NAFDAC register with an active registration (B4-3798). 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 Amitryptylline HCl Tablets is used for

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

Boxed warning: Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. …
What it is used for

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Possible side effects

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. …

Do not use if

Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. …

Warnings

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. …

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

Check your pack of Amitryptylline HCl Tablets

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 Amitryptylline HCl Tablets

What is in Amitryptylline HCl Tablets?

Amitryptylline HCl Tablets contains Amitriptyline Hydrochloride (25 mg), as tablet, according to its NAFDAC registration record.

Is Amitryptylline HCl Tablets registered with NAFDAC?

Yes. Amitryptylline HCl Tablets is listed on the NAFDAC register under registration number B4-3798, and its registration is active as of 6 November 2026.

Has Amitryptylline HCl Tablets been flagged as fake or recalled?

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

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

Run a free authenticity scan with the NAFDAC number B4-3798, 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 Amitryptylline HCl Tablets used for?

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. (Summarised from the official U.S. FDA label for amitriptyline hydrochloride. Always follow your doctor or pharmacist.)

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