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Rosart Tablets 25 mg

NAFDAC Reg. No. 04-8237 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Rosart Tablets 25 mg
NAFDAC number
04-8237
Active ingredient
Losartan Potassium
Strength
25 mg
Form
Tablet
Pack size
5 x 10's (in blisters)
Manufacturer
Not listed
Applicant (holder)
Ranbaxy Nigeria Limited
Approved
28 Aug 2024
Status
Active View on NAFDAC ↗
Registration valid to
27 Aug 2029
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Rosart Tablets 25 mg is on the NAFDAC register with an active registration (04-8237). 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 Rosart Tablets 25 mg is used for

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

Boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [see Warnings and Precautions (5.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. …
What it is used for

Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. …

Possible side effects

Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Do not use if

Losartan potassium tablets, are contraindicated: • In patients who are hypersensitive to any component of this product. • For coadministration with aliskiren in patients with diabetes. • Hypersensitivity to any component. ( 4 ) • Coadministration with aliskiren in patients with diabetes. ( 4 )

Warnings

• Hypotension: Correct volume or salt depletion prior to administration of losartan potassium tablets. ( 5.2 ) • Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Losartan potassium tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Losartan potassium tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

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

Check your pack of Rosart Tablets 25 mg

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 Rosart Tablets 25 mg

What is in Rosart Tablets 25 mg?

Rosart Tablets 25 mg contains Losartan Potassium (25 mg), as tablet, according to its NAFDAC registration record.

Is Rosart Tablets 25 mg registered with NAFDAC?

Yes. Rosart Tablets 25 mg is listed on the NAFDAC register under registration number 04-8237, and its registration is active as of 5 November 2026.

Has Rosart Tablets 25 mg been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Rosart Tablets 25 mg in our automatically synced alert list.

How can I check that my pack of Rosart Tablets 25 mg is genuine?

Run a free authenticity scan with the NAFDAC number 04-8237, 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 Rosart Tablets 25 mg used for?

Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Reduction of the risk of stroke in patients with hypertension and left (Summarised from the official U.S. FDA label for losartan potassium. Always follow your doctor or pharmacist.)

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