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Diovan Side Effects

Generic Name: valsartan

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

For the Consumer

Applies to valsartan: oral capsule, oral solution, oral tablet

Along with its needed effects, valsartan (the active ingredient contained in Diovan) 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

  • Bloody urine
  • cold sweats
  • confusion
  • decreased frequency or amount of urine
  • difficult breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying position
  • fainting
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • nausea
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • swelling of the face, fingers, or lower legs
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Rare

  • Chills
  • fever
  • hoarseness
  • sore throat
  • swelling of the mouth, hands, or feet
  • trouble with swallowing or breathing (sudden)

Incidence Not Known

  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • upper right abdominal or stomach pain
  • yellow eyes and skin

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

  • Abdominal or stomach pain
  • back pain
  • blurred vision
  • cold or flu-like symptoms
  • coughing
  • diarrhea
  • difficulty with moving
  • headache
  • muscle pain or stiffness
  • pain, swelling, or redness in the joints

Incidence Not Known

For Healthcare Professionals

Applies to valsartan: oral capsule, 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]

References

1. 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

2. "Product Information. Diovan (valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

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

4. 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

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

6. 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

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, Roch-Ramel F, Brunner HR "Renal effects of angiotensin II receptor blockade in normotensive subjects." Kidney Int 49 (1996): 1787-90

11. 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

12. 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

13. Marquart-Elbaz C, Grosshans E, Lipsker D, Lipsker D "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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