Valsartan Side Effects

It is possible that some side effects of valsartan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to valsartan: oral capsule, oral tablet

As well as its needed effects, valsartan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking valsartan, check with your doctor immediately:

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 valsartan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • Hair loss
  • thinning of the hair

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 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]

References

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

2. 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

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. Irons BK, Kumar A "Valsartan-induced angioedema." Ann Pharmacother 37 (2003): 1024-7

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

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

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