Valsartan

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Indication Starting Dose Dose Range* Hypertension
• Adults ( 2.2 ) 80 to 160 mg once daily 80 to 320 mg once daily 1 to 16 years ( 2.3 ) 1 mg/kg once daily Up to 40 mg daily 1 to 4 mg/kg once daily Up to 160 mg daily Heart Failure ( 2.4 ) 40 mg twice daily 40 to 160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20 to 160 mg twice daily *As tolerated by patient 2.1 Important Dosage and Preparation Information Valsartan tablet and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [see Clinical Pharmacology ( 12.3 )]. Use of the oral suspension is recommended:
• in pediatric patients aged 1 to 5 years
• in patients ≥ 6 >5 years of age who cannot swallow tablets and
• in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan. When switching between suspension and tablets, the dose of valsartan may need to be adjusted.
• in pediatric patients aged 1 to 5 years
• in patients >5 years of age who cannot swallow tablets and
• in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan. When switching between suspension and tablets, the dose of valsartan may need to be adjusted. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension)
• Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes.
• Allow the suspension to stand for a minimum of 1 hour.
• After the standing time, shake the suspension for a minimum of 1 additional minute.
• Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients.
• The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30ºC/86ºF) or up to 75 days at refrigerated conditions (2ºC to 8ºC/35ºF to 46ºF) in the glass bottle with a child-resistant screw-cap closure.
• Shake the bottle well (at least 10 seconds) prior to dispensing the suspension. *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc. 2.2 Adult Hypertension The recommended starting dose of valsartan tablets is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. Valsartan tablets may be administered with other antihypertensive agents. 2.3 Pediatric Hypertension 1 to 16 Years of Age The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total). A higher starting dose of 2 mg/kg may be considered in selected cases when a greater reduction of blood pressure is needed. The dosage should be adjusted according to blood pressure response and tolerability, up to a maximum dose of 4 mg/kg once daily (maximum daily dose 160 mg). No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m 2 [see Use in Specific Populations ( 8.4 )]. Use of valsartan tablets is not recommended in children less than 1 year of age [see Adverse Reactions ( 6.1 ), Pediatric Use in Specific Populations ( 8.4 ), Nonclinical Toxicology ( 13.2 )]. 2.4 Heart Failure The recommended starting dose of valsartan tablets is 40 mg twice daily. Uptitrate to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses. 2.5 Post-Myocardial Infarction Valsartan tablets may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of valsartan tablets is 20 mg twice daily. Patients may be uptitrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction. Valsartan tablets may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins. 2.6 Missed Dose If a dose of valsartan tablets is missed, it should be administered as soon as possible, unless it is almost time for the next dose. The dose should not be doubled to make up for a missed dose.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• Hypertension :
• Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure :
• Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction :
• Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
• Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year.
• Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
• The overall incidence of adverse reactions with valsartan was similar to placebo.
• The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen.
• Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients.
• The most common reasons for discontinuation of therapy with valsartan were headache and dizziness.
• The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs. 1%), and abdominal pain (2% vs. 1%).
• In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%).
• In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001).
• Dose-related orthostatic effects were seen in less than 1% of patients.
• An increase in the incidence of dizziness was observed in patients treated with valsartan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).
• Pediatric Hypertension Valsartan has been evaluated for safety in 290 pediatric patients aged 1 to less than 6 years and over 400 patients aged 6 to 17 years.
• No relevant differences were identified between the adverse experience profile for pediatric patients and that previously reported for adult patients.
• Hyperkalemia was more frequently observed in pediatric patients aged 1 to 17 years with underlying chronic kidney disease (CKD).
• Cases of elevated ALT and/or AST have been reported in pediatric patients 1 to less than 6 years of age.
• These events occurred in a study population which frequently had significant comorbidities; hence, a causal relationship to valsartan could not be established.
• Heart Failure In the Valsartan Heart Failure Trial (Val-HeFT), comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs. 7% of placebo patients.
• The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients.
• All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers.
• About 93% of patients received concomitant ACE inhibitors.
• Valsartan (n=3,282) Placebo (n=2,740) Dizziness 17% 9% Hypotension 7% 2% Diarrhea 5% 4% Arthralgia 3% 2% Fatigue 3% 2% Back Pain 3% 2% Dizziness, postural 2% 1% Hyperkalemia 2% 1% Hypotension, postural 2% 1% Discontinuations occurred in 0.5% of valsartan-treated patients and 0.1% of placebo patients for each of the following:
• elevations in creatinine and elevations in potassium.
• Other adverse reactions with an incidence greater than 1% and greater than placebo included headache, nausea, renal impairment, syncope, blurred vision, upper abdominal pain and vertigo.
• From the long-term data in the Valsartan Heart Failure Trial, there did not appear to be any significant adverse reactions not previously identified.
• Post-Myocardial Infarction The table shows the percentage of patients discontinued in the valsartan and captopril-treated groups in the VALsartan In Acute myocardial iNfarcTion trial (VALIANT) with a rate of at least 0.5% in either of the treatment groups.
• Discontinuations due to renal dysfunction occurred in 1.1% of valsartan-treated patients and 0.8% of captopril-treated patients.
• Valsartan (n=4,885) Captopril (n=4,879) Discontinuation for adverse reaction 5.8% 7.7% Adverse reactions Hypotension NOS 1.4% 0.8% Cough 0.6% 2.5% Blood creatinine increased 0.6% 0.4% Rash NOS 0.2% 0.6% Clinical Laboratory Test Findings Creatinine:
• In heart failure trials, greater than 50% increases in creatinine were observed in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients.
• In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.
• Neutropenia:
• Neutropenia was observed in 1.9% of patients treated with valsartan and 0.8% of patients treated with placebo.
• Blood Urea Nitrogen (BUN):
• In heart failure trials, greater than 50% increases in BUN were observed in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients [see Warnings and Precautions ( 5.3 )].
• 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing use of valsartan.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Hypersensitivity: Angioedema has been reported.
• Some of these patients previously experienced angioedema with other drugs, including ACE inhibitors.
• Valsartan should not be re-administered to patients who have had angioedema.
• Digestive:
• Elevated liver enzymes and very rare reports of hepatitis Musculoskeletal:
• Rhabdomyolysis Renal:
• Impaired renal function, renal failure Dermatologic:
• Alopecia, bullous dermatitis Blood and Lymphatic:
• Thrombocytopenia Vascular:
• Vasculitis

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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