Exforge Side Effects

Please note - some side effects for Exforge may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Exforge - for the Consumer

Exforge

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Exforge:

Dizziness; dry cough; sore throat; stuffy nose; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fainting; fast or irregular heartbeat; numbness of an arm or leg; severe or persistent dizziness; severe or persistent muscle pain or aches; shortness of breath; sudden severe headache or vomiting; sudden unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

Exforge HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Exforge HCT:

Dizziness; dry cough; headache; indigestion; lightheadedness; muscle spasms; nausea; sore throat; stuffy nose; tiredness; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; blurred vision or other vision changes; change in the amount of urine produced; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); loss of appetite; mental or mood changes; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, drowsiness, or lightheadedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; sudden severe headache; sudden unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; yellowing of the eyes or skin.

Exforge Side Effects - for the Professional

Exforge

In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Exforge-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Exforge were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection and dizziness. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Cardiovascular

Cardiovascular side effects for amlodipine-valsartan in relation to placebo therapy have included peripheral edema (5.4% vs 3.0%). Additional cardiovascular side effects reported include orthostatic events (orthostatic hypotension and postural dizziness) in less than 1% of patients, palpitations, bradycardia, vasculitis, syncope, arrhythmia, heart murmur, and tachycardia.

The incidence of peripheral edema is lower with the combination of amlodipine-valsartan than with amlodipine alone.

Dermatologic

Dermatologic side effects including flushing, pruritus, rash, hyperhidrosis, exanthema, eczema, alopecia, and erythema multiforme have been reported.

Endocrine

Endocrine side effects have included diabetes mellitus.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, constipation, dyspepsia, abdominal pain, anorexia, dysphagia, pancreatitis, gastritis, vomiting, abdominal discomfort and distention, gastroenteritis, dry mouth, flatulence, tonsillitis, and colitis.

Genitourinary

Genitourinary side effects have included hematuria, pollakiuria, micturation frequency, nocturia, impotence, erectile dysfunction, and cystitis.

Hematologic

Hematologic side effects have included leucopenia, purpura, and thrombocytopenia.

Hepatic

Hepatic side effects including elevated liver enzymes have been reported in patients treated with amlodipine-valsartan.

Metabolic

Metabolic side effects have included hyperkalemia, gout, hyperglycemia, weight gain, weight loss, and hypercholesterolemia.

Musculoskeletal

Musculoskeletal side effects including arthralgia, back pain, muscle spasms, pain in extremities, myalgia, osteoarthritis, joint swelling, muscle cramps, and musculoskeletal chest pain have been reported.

Nervous system

Nervous system side effects for amlodipine-valsartan in relation to placebo therapy have included dizziness (2.1% vs 0.9%). Other nervous system side effects including headache (4.3%), insomnia, peripheral neuropathy, tremor, sciatica, paresthesia, cerviocobrachial syndrome, carpal tunnel syndrome, hypoesthesia, and somnolence have been reported.

Ocular

Ocular side effects including abnormal vision, conjunctivitis, diplopia, and eye pain have been reported.

Other

Other side effects have included ear pain, tinnitus, fatigue, asthenia, malaise, lymphadenopathy, fever, edema, and chest pain.

Psychiatric

Psychiatric side effects including anxiety, nervousness, abnormal dreams, depersonalization, and depression have been reported.

Renal

Renal side effects including nephrolithiasis, and increases in serum creatinine and blood urea nitrogen (BUN) have been reported.

In hypertensive patients, greater than 50% increases in serum creatinine were reported in 0.4% of patients given amlodipine-valsartan compared with 0.6% in those given placebo. In heart failure patients, greater than 50% increases in creatinine were reported in 3.9% of valsartan-treated patients compared with 0.9% of placebo-treated patients. In postmyocardial infarction patients, doubling of serum creatinine were reported in 4.2% of patients given valsartan and in 3.4% of captopril-treated patients.

In hypertensive patients, greater than 50% increases in BUN were reported in 5.5% of amlodipine-valsartan treated patients compared with 4.7% of placebo-treated patients. In heart failure patients, greater than 50% increases in BUN were reported in 16.6% of patients given valsartan compared with 6.3% of patients given placebo.

Respiratory

Respiratory side effects for amlodipine-valsartan in relation to placebo therapy have included nasopharyngitis (4.3% vs 1.8%) and upper respiratory tract infection (2.9% vs 2.1%). Other respiratory side effects have included cough, dyspnea, nasopharyngitis, sinusitis, bronchitis, pharyngitis, pharyngolaryngeal pain, sinus/nasal congestion, dyspnea, epistaxis, pneumonia, and dysphonia.

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