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Candesartan 8 mg Tablets

NAFDAC Reg. No. B4-5705 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Candesartan 8 mg Tablets
NAFDAC number
B4-5705
Active ingredient
Candesartan Cilexetil
Strength
8 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Korlyns Pharmaceuticals Ltd
Approved
16 Dec 2021
Status
Active View on NAFDAC ↗
Registration valid to
15 Dec 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Candesartan 8 mg Tablets is on the NAFDAC register with an active registration (B4-5705). 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 Candesartan 8 mg Tablets is used for

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

Boxed warning: FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. …
What it is used for

Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to

Possible side effects

· Most common adverse reactions which caused adult patients to discontinue therapy for: o Hypertension were headache (0.6%) and dizziness (0.3%) (6.1). o Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) (5.5). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Do not use if

Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes [see Drug Interactions (7.4)]. Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes (4).

Warnings

5.1 Fetal Toxicity Candesartan cilexetil 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. When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible [see Use in Specific Populations (8.1)]. 5.2 Morbidity in Infants Children

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Candesartan cilexetil 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 Candesartan 8 mg 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 Candesartan 8 mg Tablets

What is in Candesartan 8 mg Tablets?

Candesartan 8 mg Tablets contains Candesartan Cilexetil (8 mg), as tablet, according to its NAFDAC registration record.

Is Candesartan 8 mg Tablets registered with NAFDAC?

Yes. Candesartan 8 mg Tablets is listed on the NAFDAC register under registration number B4-5705, and its registration is active as of 27 October 2026.

Has Candesartan 8 mg Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Candesartan 8 mg Tablets in our automatically synced alert list.

How can I check that my pack of Candesartan 8 mg Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-5705, 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 Candesartan 8 mg Tablets used for?

Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to (Summarised from the official U.S. FDA label for candesartan cilexetil. Always follow your doctor or pharmacist.)

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