Atacand HCT (Candesartan Cilexetil/Hydrodchlorothiazide) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

February 2016

Summary View


Drug Interactions

Interactions with Candesartan Cilexetil

  • Coadministration of ATACAND HCT with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.
Interactions with Hydrochlorothiazide
  • Diazoxide - the hyperglycemic effect of diazoxide may be enhanced by thiazides.
  • Noradrenaline - Thiazides may decrease arterial responsiveness to noradrenaline, but not enough to preclude effectiveness of the pressor agent for therapeutic use.
  • Steroids or Adrenocorticotropic Hormone - Hypokalemia may develop during concomitant use of steroids or adrenocorticotropic hormone (ACTH).
  • Cytotoxic products - Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
  • Cyclosporine - Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.


February 2015

Summary View


Drug Interactions
  • Lithium − Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use.


April 2013

Summary View


  • Atacand HCT is contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs.
  • Do not co-administer Aliskiren with Atacand HCT in patients with diabetes


  • Atacand HCT can cause symptomatic hypotension…
  • Impaired Renal Function - Monitor renal function periodically in patients treated with Atacand HCT…
  • Potassium Abnormalities - Drugs that inhibit the renin-angiotensin system can cause hyperkalemia…


  • Metabolic Disturbances - Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides…
Systemic Lupus Erythematosus
  • Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Drug Interactions
  • Interactions common to both Candesartan Cilexetil and Hydrochlorothiazides - Lithium − Renal clearance of lithium is reduced by thiazides and increases the risk of lithium toxicity.
  • Interactions with Candesartan Cilexetil – Dual Blockade of the Renin-Angiotensin System (RAS) - Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy…
  • Interactions with Hydrochlorothiazide - Stagger the dosage of hydrochlorothiazide and ion exchange resins such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins.
  • Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may predispose to digoxin toxicity.


Postmarketing Experience
  • Immunologic: Angioedema
  • Respiratory System Disorders: Cough
  • Skin and Appendages Disorders – rash 


Page Last Updated: 03/14/2016
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