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Diovan Side Effects

Generic name: valsartan

Medically reviewed by Drugs.com. Last updated on Oct 26, 2022.

Note: This document contains side effect information about valsartan. Some dosage forms listed on this page may not apply to the brand name Diovan.

Summary

Common side effects of Diovan include: dizziness and increased serum potassium. Other side effects include: hypotension. Continue reading for a comprehensive list of adverse effects.

Applies to valsartan: oral extemporaneous suspension, oral tablets.

Warning

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 114 115 116 a (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue as soon as possible.1 115 116 a

Side effects include:

Viral infection, fatigue, abdominal pain; also, dizziness, hypotension, postural dizziness or hypotension, hyperkalemia, arthralgia, diarrhea, and back pain in patients with heart failure.

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 (the active ingredient contained in Diovan) 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 (the active ingredient contained in Diovan) 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 14 (1996): 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 18 (1996): 797-810

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

4. "Product Information. Diovan (valsartan)." Novartis Pharmaceuticals (2001):

5. McInnes GT "Clinical advantage of valsartan." Cardiology 91 (1999): 14-8

6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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 37 (1997): 101-7

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

9. Irons BK, Kumar A "Valsartan-induced angioedema." Ann Pharmacother 37 (2003): 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 25 (1995): 602-9

11. Burnier M, Roch-Ramel F, Brunner HR "Renal effects of angiotensin II receptor blockade in normotensive subjects." Kidney Int 49 (1996): 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 57 (1996): s132-6

13. Marquart-Elbaz C, Grosshans E "Sartans, angiotensin II receptor antagonists, can induce psoriasis." Br J Dermatol 147 (2002): 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 60 (2005): 204-7

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

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

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