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

Respiratory

Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea

Hypersensitivity

Very rare (less than 0.01%): Angioedema

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.

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

Metabolic

Common (1% to 10%): Hyperkalemia, hyponatremia

Renal

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

Dermatologic

Rare (less than 0.1%): Pruritus, rash, alopecia
Postmarketing reports: Bullous dermatitis

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

Musculoskeletal

Common (1% to 10%): Back pain, muscle cramps, myalgias
Very rare (less than 0.01%): Rhabdomyolysis

Psychiatric

Frequency not reported: Anxiety, insomnia, paresthesias, somnolence

Genitourinary

Very rare (less than 0.01%): Impotence

Hematologic

Uncommon (0.1% to 1%): Hematocrit decreased, hemoglobin decreased, neutropenia
Postmarketing reports: Thrombocytopenia, vasculitis

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.

Very rare (less than 0.01%): Hepatitis
Frequency not reported: Hepatic enzymes increased

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