Exforge Side Effects Center

Last updated on RxList: 7/8/2022
Exforge Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Exforge?

Exforge (amlodipine and valsartan) is a combination of a calcium channel blocker and an angiotensin II receptor antagonist used to treat high blood pressure (hypertension). Exforge is usually given after other drugs have been tried without successful treatment of hypertension.

What Are Side Effects of Exforge?

Common side effects of Exforge include:

  • dizziness,
  • spinning sensation, or lightheadedness as your body adjusts to the medication.

Other side effects of Exforge include flushing, and cold symptoms such as runny/stuffy nose, sneezing, and sore throat.

Tell your doctor if you have serious side effects of Exforge including:

  • swelling hands/ankles/feet,
  • fainting,
  • fast heartbeat,
  • unusual change in the amount of urine,
  • symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), or
  • signs of infection (such as fever, chills, persistent sore throat).

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Exforge?

Exforge is available in dosage strengths ranging from amlodipine/valsartan 5/160 mg tablets to 10/320 mg tablets.

What Drugs, Substances, or Supplements Interact with Exforge?

Exforge may interact with heart medication, potassium supplements or salt substitutes, diuretics (water pills), or other medications that lower blood pressure. Tell your doctor all medications you are taking.

Exforge During Pregnancy and Breastfeeding

Exforge is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Exforge (amlodipine and valsartan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Exforge Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • swelling in your hands or feet, rapid weight gain; or
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects include:

  • swelling in your hands or feet;
  • dizziness; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Exforge Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Studies With Exforge

Exforge has been evaluated for safety in over 2600 patients with hypertension; over 1440 of these patients were treated for at least 6 months and over 540 of these patients were treated for at least 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

The hazards [see WARNINGS AND PRECAUTIONS] of valsartan are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter.

The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race. In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Exforgetreated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Exforge were peripheral edema (0.4%), and vertigo (0.2%).

The adverse reactions that occurred in placebo-controlled clinical trials in at least 2% of patients treated with Exforge but at a higher incidence in amlodipine/valsartan patients (n=1437) than placebo (n=337) included peripheral edema (5.4% vs 3.0%), nasopharyngitis (4.3% vs 1.8%), upper respiratory tract infection (2.9% vs 2.1%) and dizziness (2.1% vs 0.9%).

Orthostatic events (orthostatic hypotension and postural dizziness) were seen in less than 1% of patients.

Studies With Valsartan

Diovan® has been evaluated for safety in more than 4000 hypertensive patients in clinical trials. In trials in which valsartan was compared to an angiotensin-converting enzyme (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).

Clinical Lab Test Findings

Creatinine

In heart failure patients, 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.

Blood Urea Nitrogen (BUN)

In hypertensive patients, greater than 50% increases in BUN were observed in 5.5% of Exforge-treated patients compared to 4.7% of placebo-treated patients. In heart failure patients, greater than 50% increases in BUN were observed in 16.6% of valsartan-treated patients compared to 6.3% of placebotreated patients [see WARNINGS AND PRECAUTIONS].

Neutropenia

Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.

Postmarketing Experience

The following additional adverse reactions have been reported in postmarketing experience. 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.

Amlodipine

Gynecomastia has been reported infrequently and a causal relationship is uncertain. Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.

Valsartan

The following additional adverse reactions have been reported in postmarketing experience with valsartan:

Hypersensitivity

Angioedema has been reported. Some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should not be re-administered to patients who have had angioedema.

Digestive

Elevated liver enzymes and reports of hepatitis

Musculoskeletal

Rhabdomyolysis

Renal

Impaired renal function, renal failure

Dermatologic

Alopecia, bullous dermatitis

Blood And Lymphatic

Thrombocytopenia

Vascular

Vasculitis

DRUG INTERACTIONS

No drug interaction studies have been conducted with Exforge and other drugs, although studies have been conducted with the individual amlodipine and valsartan components.

Amlodipine

Impact Of Other Drugs On Amlodipine

CYP3A Inhibitors

Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see CLINICAL PHARMACOLOGY].

CYP3A Inducers

No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g. rifampicin, St. John's Wort).

Sildenafil

Monitor for hypotension when sildenafil is coadministered with amlodipine [see CLINICAL PHARMACOLOGY].

Impact Of Amlodipine On Other Drugs

Simvastatin

Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see CLINICAL PHARMACOLOGY].

Immunosuppressants

Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see CLINICAL PHARMACOLOGY].

Valsartan

Agents Increasing Serum Potassium

Concomitant use of valsartan with other agents that block the reninangiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual Blockade Of The Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS.

Do not coadminister aliskiren with Exforge in patients with diabetes. Avoid use of aliskiren with Exforge in patients with renal impairment (GFR <60 mL/min).

Lithium

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.

Read the entire FDA prescribing information for Exforge (Amlodipine and Valsartan)

© Exforge Patient Information is supplied by Cerner Multum, Inc. and Exforge Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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