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Valsartan Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 26, 2023.

Applies to valsartan: oral solution, oral tablet.

Warning

Oral route (Capsule; Tablet; Solution)

When pregnancy is detected, discontinue valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Serious side effects of Valsartan

Along with its needed effects, valsartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking valsartan:

Less common

Rare

Incidence not known

Other side effects of Valsartan

Some side effects of valsartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Incidence not known

For Healthcare Professionals

Applies to valsartan: oral capsule, oral liquid, oral tablet.

Nervous system

Very common (10% or more): Headache (up to 14%), dizziness (up to 14%)

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Vertigo[Ref]

Respiratory

Common (1% to 10%): Cough

Uncommon (0.1% to 1%): Dyspnea[Ref]

Hypersensitivity

A 71-year-old woman experienced an acute onset of angioedema and a photosensitive pruritic rash after 3 months of valsartan therapy. Her symptoms dissipated and the rash resolved after treatment with subcutaneous epinephrine, intravenous methylprednisolone, diphenhydramine, and emollient cream.

A unique case of dose-dependent, valsartan-induced angioedema has been reported. Two hours after initiating a dose increase (160 to 320 mg/day) of valsartan, a patient developed angioedema (i.e., swelling of lips and tongue). Symptoms resolved following a reduction in dose to the original dosage of 160 mg/day.[Ref]

Very rare (less than 0.01%): Angioedema[Ref]

Cardiovascular

Common (1% to 10%): Symptomatic hypotension in 5.5% of heart failure patients in clinical trials

Rare (less than 0.1%): Palpitations, chest pain

Frequency not reported: Dizziness related to orthostatic hypotension

Postmarketing reports: Heart failure[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia, hyponatremia[Ref]

Renal

Frequency not reported: Impaired renal function, increases in serum creatinine concentrations, blood urea nitrogen, and potassium

Postmarketing reports: Renal failure[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, alopecia

Postmarketing reports: Bullous dermatitis[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, flatulence

Postmarketing reports: Taste disturbance (i.e., altered sensitivity of basic tastes) has been reported following repeated dosing[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle cramps, myalgias

Very rare (less than 0.01%): Rhabdomyolysis[Ref]

Psychiatric

Frequency not reported: Anxiety, insomnia, paresthesias, somnolence[Ref]

Genitourinary

Very rare (less than 0.01%): Impotence[Ref]

Hematologic

Uncommon (0.1% to 1%): Hematocrit decreased, hemoglobin decreased, neutropenia

Postmarketing reports: Thrombocytopenia, vasculitis[Ref]

Hepatic

Valsartan-associated hepatotoxicity in a patient with hepatitis B surface antigen (HBs-Ag) positivity (without signs and symptoms) has been reported. After 1 month of treatment with valsartan, this patient developed pruritic erythematous skin changes, nausea, jaundice, right subcostal abdominal pain, elevated liver enzymes, and mild hepatomegaly. Signs and symptoms of hepatotoxicity resolved within 2 to 3 weeks following discontinuation of valsartan and the patient remained asymptomatic after 6 months of follow-up.[Ref]

Very rare (less than 0.01%): Hepatitis

Frequency not reported: Hepatic enzymes increased[Ref]

Frequently asked questions

References

1. Holwerda NJ, Fogari R, Angeli P, et al. Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: efficacy and safety compared with placebo and enalapril. J Hypertens. 1996;14:1147-115.

2. Oparil S, Dyke S, Harris F, et al. The efficacy and safety of valsartan compared with placebo in the treatment of patients with essential hypertension. Clin Ther. 1996;18:797-810.

3. Waeber B, Burnier M, Nussberger J, Brunner HR. Experience with angiotensin II antagonists in hypertensive patients. Clin Exp Pharmacol Physiol. 1996;23 ( Suppl:s142-6.

4. Product Information. Diovan (valsartan). Novartis Pharmaceuticals. 2001;PROD.

5. McInnes GT. Clinical advantage of valsartan. Cardiology. 1999;91:14-8.

6. Cerner Multum, Inc. UK Summary of Product Characteristics.

7. Benz J, Oshrain C, Henry D, Avery C, Chiang YT, Gatlin M. Valsartan, a new angiotensin II receptor antagonist: a double-blind study comparing the incidence of cough with lisinopril and hydrochlorothiazide. J Clin Pharmacol. 1997;37:101-7.

8. Frye CB, Pettigrew TJ. Angioedema and photosensitive rash induced by valsartan. Pharmacotherapy. 1998;18:866-8.

9. Irons BK, Kumar A. Valsartan-induced angioedema. Ann Pharmacother. 2003;37:1024-7.

10. Burnier M, Hagman M, Nussberger J, Biollaz J, Armagnac C, Brouard R, Weber B, Brunner HR. Short-term and sustained renal effects of angiotensin II receptor blockade in healthy subjects. Hypertension. 1995;25:602-9.

11. Burnier M, Roch-Ramel F, Brunner HR. Renal effects of angiotensin II receptor blockade in normotensive subjects. Kidney Int. 1996;49:1787-90.

12. Ziai F, Ots M, Provoost AP, Troy JL, Rennke HG, Brenner BM, Mackenzie HS. The angiotensin receptor antagonist, irbesartan, reduces renal injury in experimental chronic renal failure. Kidney Int Suppl. 1996;57:s132-6.

13. Marquart-Elbaz C, Grosshans E. Sartans, angiotensin II receptor antagonists, can induce psoriasis. Br J Dermatol. 2002;147:617-8.

14. Tsuruoka S, Wakaumi M, Ioka T, et al. Angiotensin II receptor blocker-induces blunted taste sensitivity: comparison of candesartan and valsartan. Br J Clin Pharmacol. 2005;60:204-7.

15. Flores CA, Ardiles LG, Aros CA, et al. Valsartan-Induced Hematocrit Changes in Renal Transplant Patients. Transplant Proc. 2005;37:1586-1588.

16. Kiykim A, Altintas E, Sezgin O, et al. Valsartan-induced hepatotoxicity in a HBs-Ag-Positive patient. Am J Gastroenterol. 2003;98:507.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.