Candesartan

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

• Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ).ICD-10: I10

• 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)].contraindicated

Starting Dose Target Dose Adult Hypertension ( 2.1 ) 16 mg tablet once daily 8 - 32 mg tablet total daily dose Pediatric Hypertension (1 to < 6 years) ( 2.2 ) 0.20 mg/kg oral suspension once daily 0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to < 17 years) ( 2.2 ) < 50 kg 4 – 8 mg tablet once daily > 50 kg 8 – 16 mg tablet once daily < 50 kg 4 – 16 mg tablet once daily or consider divided dose > 50 kg 4 – 32 mg tablet once daily or consider divided dose Adult Heart Failure ( 2.3 ) 4 mg tablet once daily 32 mg tablet once daily 1 1 The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by patient. 2.1 Adult Hypertension Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of candesartan cilexetil tablets are 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil tablets. Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency.

• Observe for signs and symptoms of hypotension ( 5.3 ). • Monitor renal function ( 5.4 ) and potassium levels ( 5.5 ). 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 as soon as possible [see Use in Specific Populations ( 8.1 )]. 5.2 Morbidity in Infants Children < 1 year of age must not receive candesartan cilexetil for hypertension. Drugs that act directly on the renin-angiotensin system (RAS) can have effects on the development of immature kidneys. 5.3 Hypotension Candesartan cilexetil can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Patients with symptomatic hypotension may require temporarily reducing the dose of candesartan cilexetil, diuretic or both, and volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with candesartan cilexetil.

• Most common adverse reactions which caused adult patients to discontinue therapy for: ○ Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ). ○ 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 Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo. The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (i.e., 108 of 3260) of patients treated with candesartan cilexetil as monotherapy and 3.5% (i.e., 39 of 1106) of patients treated with placebo.

· Nursing Mothers : Either nursing or drug should be discontinued ( 8.2 ). · Pediatrics : Children < 1 year of age must not receive candesartan cilexetil for hypertension ( 5.2 ). Inhibitors of the renin-angiotensin system can cause renal abnormalities in neonatal animals ( 12.3 ). 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. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue candesartan cilexetil as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Distribution The volume of distribution of candesartan is 0.13 L/kg. Candesartan is highly bound to plasma proteins (>99%) and does not penetrate red blood cells.

No lethality was observed in acute toxicity studies in mice, rats, and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil. In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg. The most likely manifestation of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Candesartan cannot be removed by hemodialysis. Treatment: To obtain up-to-date information about the treatment of overdose, consult your Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient

• Jun 4, 1998NDANDA020838Ani Pharms
• Sep 5, 2000NDANDA021093Ani Pharms
• Dec 4, 2012ANDAANDA090704Pharmobedient
• May 3, 2013ANDAANDA078702Mylan
• Feb 27, 2015ANDAANDA204100Macleods Pharms Ltd
• Dec 5, 2016ANDAANDA203813Macleods Pharms Ltd
• Jun 20, 2017ANDAANDA209119Alembic
• Aug 23, 2017ANDAANDA091390Zydus Lifesciences

1. 1Fatigue4,8387.8%
2. 2Dyspnoea4,8287.8%
3. 3Off Label Use4,7927.8%
4. 4Nausea4,6187.5%
5. 5Dizziness4,2947.0%
6. 6Diarrhoea4,1796.8%
7. 7Drug Ineffective4,1016.6%
8. 8Headache4,0816.6%
9. 9Pain3,5315.7%
10. 10Vomiting3,3865.5%
11. 11Malaise3,2835.3%
12. 12Hypertension3,2455.3%
13. 13Arthralgia3,1735.1%
14. 14Asthenia3,1015.0%
15. 15Fall2,9914.8%

The 10 most recently updated of 204 ClinicalTrials.gov registrations naming Candesartan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
  Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research Institute
  NCT07547878updated 2026-05-08
• The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.
  Recruiting · Phase 4 · Interventional · 100 enrolled · Ziekenhuis Oost-Limburg
  NCT07513883updated 2026-04-07
• The COVID-RASi Trial (COVID-19)
  Completed · Phase 3 · Interventional · 372 enrolled · Ottawa Heart Institute Research Corporation
  NCT04591210updated 2026-01-28
• Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
  Completed · Phase 1 · Interventional · 18 enrolled · Tanabe Pharma Corporation
  NCT01976572updated 2026-01-07
• Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury
  Enrolling by invitation · Phase 2 · Interventional · 672 enrolled · University of California, San Francisco
  NCT05826912updated 2025-12-22
• Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
  Not yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  NCT07262710updated 2025-12-04
• An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan
  Completed · Observational · 4,936 enrolled · Bayer
  NCT06697353updated 2025-10-08
• Improved Treatment and Monitoring of Alzheimer's Disease
  Not yet recruiting · Phase 2 · Interventional · 180 enrolled · Rune Skovgaard Rasmussen
  NCT07135245updated 2025-08-22
• Candesartan for Migraine Prevention:
  Completed · Phase 2 · Interventional · 450 enrolled · St. Olavs Hospital
  NCT04574713updated 2025-08-13
• Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
  Enrolling by invitation · Phase 2 · Interventional · 252 enrolled · Shin Poong Pharmaceutical Co. Ltd.
  NCT07064525updated 2025-07-14

Frequently asked questions

How does Candesartan work?

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

What is Candesartan used for?

According to FDA labeling, Candesartan carries indications including: Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Candesartan?

Candesartan is classified as Angiotensin II receptor blockers (ARBs), plain, Angiotensin 2 Receptor Blocker, Angiotensin 2 Receptor Antagonists, Decreased Blood Pressure, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.

What are the brand names for Candesartan?

Candesartan is marketed under brand names including Atacand, Atacand HCT.

What are the contraindications for Candesartan?

Candesartan labeling lists contraindications including: 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)].. Always consult the full prescribing information and a clinician.