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.
From the official U.S. FDA label for candesartan cilexetil, the active ingredient registered with NAFDAC.
Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to
· 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. …
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).
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
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. …
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Candesartan/HCT Sandoz 16 mg/12.5 mg Tablets contains Candesartan Cilexetil; Hydrochlorothiazide (16 mg; 12.5 mg), as tablet, according to its NAFDAC registration record.
Yes. Candesartan/HCT Sandoz 16 mg/12.5 mg Tablets is listed on the NAFDAC register under registration number B4-3524, and its registration is active as of 27 October 2026.
No WHO falsified or substandard medical product alert currently matches Candesartan/HCT Sandoz 16 mg/12.5 mg Tablets in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-3524, 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.
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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