Exforge HCT Side Effects

Please note - some side effects for Exforge HCT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Exforge HCT - for the Consumer

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; headache; indigestion; light-headedness; mild back pain; muscle spasms; nausea; sore throat or discomfort when swallowing; stuffy nose; tiredness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Exforge HCT:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Exforge HCT Side Effects - for the Professional

Exforge HCT

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 clinical practice.

In the controlled trial of Exforge HCT, where only the maximum dose (10/320/25 mg) was evaluated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

The overall frequency of adverse reactions was similar between men and women, younger (<65 years) and older (>65 years) patients, and black and white patients. In the active controlled clinical trial, discontinuation because of adverse events occurred in 4.0% of patients treated with Exforge HCT 10/320/25 mg compared to 2.9% of patients treated with valsartan/HCTZ 320/25 mg, 1.6% of patients treated with amlodipine/valsartan 10/320 mg, and 3.4% of patients treated with HCTZ/amlodipine 25/10 mg. The most common reasons for discontinuation of therapy with Exforge HCT were dizziness (1.0%) and hypotension (0.7%).

The most frequent adverse events that occurred in the active controlled clinical trial in at least 2% of patients treated with Exforge HCT are presented in the table below:

Preferred Term	Aml/Val/HCTZ 10/320/25 mg N=582 n (%)	Val/HCTZ 320/25 mg N=559 n (%)	Aml/Val 10/320 mg N=566 n (%)	HCTZ/Aml 25/10 mg N=561 n (%)
Dizziness	48 (8.2)	40 (7.2)	14 (2.5)	23 (4.1)
Edema	38 (6.5)	8 (1.4)	65 (11.5)	63 (11.2)
Headache	30 (5.2)	31 (5.5)	30 (5.3)	40 (7.1)
Dyspepsia	13 (2.2)	5 (0.9)	6 (1.1)	2 (0.4)
Fatigue	13 (2.2)	15 (2.7)	12 (2.1)	8 (1.4)
Muscle spasms	13 (2.2)	7 (1.3)	7 (1.2)	5 (0.9)
Back pain	12 (2.1)	13 (2.3)	5 (0.9)	12 (2.1)
Nausea	12 (2.1)	7 (1.3)	10 (1.8)	12 (2.1)
Nasopharyngitis	12 (2.1)	13 (2.3)	13 (2.3)	12 (2.1)

Orthostatic events (orthostatic hypotension and postural dizziness) were seen in 0.5% of patients. Other adverse reactions that occurred in clinical trials with Exforge HCT (>0.2%) are listed below. It cannot be determined whether these events were causally related to Exforge HCT.

Cardiac Disorders: tachycardia

Ear and Labyrinth Disorders: vertigo, tinnitus

Eye Disorders: vision blurred

Gastrointestinal Disorders: diarrhea, abdominal pain upper, vomiting, abdominal pain, toothache, dry mouth, gastritis, hemorrhoids

General Disorders and Administration Site Conditions: asthenia, non-cardiac chest pain, chills, malaise

Infections and Infestations: upper respiratory tract infection, bronchitis, influenza, pharyngitis, tooth abscess, gastroenteritis viral, respiratory tract infection, rhinitis, urinary tract infection

Injury, Poisoning and Procedural Complications: back injury, contusion, joint sprain, procedural pain

Investigations: blood uric acid increased, blood creatine phosphokinase increased, weight decreased

Metabolism and Nutrition Disorders: hypokalaemia, diabetes mellitus, hyperlipidemia, hyponatremia

Musculoskeletal and Connective Tissue Disorders: pain in extremity, arthralgia, musculoskeletal pain, muscular weakness, musculoskeletal weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, tendonitis

Nervous System Disorders: parasthesia, somnolence, syncope, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, head discomfort, lethargy, sinus headache, tremor

Psychiatric Disorders: anxiety, depression, insomnia

Renal and Urinary Disorders: pollakiuria

Reproductive System and Breast Disorders: erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders: dyspnea, nasal congestion, cough, pharyngolaryngeal pain

Skin and Subcutaneous Tissue Disorders: pruritus, hyperhidrosis, night sweats, rash

Vascular Disorders: hypotension

Isolated cases of the following clinically notable adverse reactions were also observed in clinical trials: anorexia, constipation, dehydration, dysuria, increased appetite, viral infection.

Amlodipine

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Other adverse reactions not listed above that have been reported in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain were:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, vasculitis

Central and Peripheral Nervous System: neuropathy peripheral, tremor

Gastrointestinal: anorexia, dysphagia, pancreatitis, gingival hyperplasia

General: allergic reaction, hot flushes, malaise, rigors, weight gain

Musculoskeletal System: arthrosis, muscle cramps

Psychiatric: sexual dysfunction (male and female), nervousness, abnormal dreams, depersonalization

Skin and Appendages: angioedema, erythema multiforme, rash erythematous, rash maculopapular

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus

Urinary System: micturition frequency, micturition disorder, nocturia

Autonomic Nervous System: sweating increased

Metabolic and Nutritional: hyperglycemia, thirst

Hemopoietic: leukopenia, purpura, thrombocytopenia

Other adverse reactions reported with amlodipine at a frequency of ≤0.1% of patients include: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.

Adverse reactions reported for amlodipine for indications other than hypertension may be found in its full prescribing information.

Valsartan  

Valsartan has been evaluated for safety in more than 4,000 hypertensive patients in clinical trials. 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 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).

Other adverse reactions, not listed above, occurring in >0.2% of patients in controlled clinical trials with valsartan are:

Digestive: flatulence

Respiratory: sinusitis, pharyngitis

Urogenital: impotence

Adverse reactions reported for valsartan for indications other than hypertension may be found in the prescribing information for Diovan.

Hydrochlorothiazide

Other adverse reactions not listed above that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body as a Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, hemolytic anemia

Hypersensitivity: photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: glycosuria, hyperuricemia

Nervous System/Psychiatric: restlessness

Renal: renal failure, renal dysfunction, interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia.

Post-Marketing Experience

Amlodipine

With 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 post-marketing experience with valsartan or valsartan/hydrochlorothiazide:

Blood and Lymphatic: There are very rare reports of thrombocytopenia.

Hypersensitivity: There are rare reports of angioedema.

Digestive: Elevated liver enzymes and very rare reports of hepatitis

Renal: Impaired renal function

Clinical Laboratory Tests: Hyperkalemia

Dermatologic: Alopecia

Vascular: Vasculitis

Nervous System: Syncope

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. 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.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension and postural dizziness (0.5%). Cardiovascular side effects of the amlodipine component have included arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, and vasculitis. Cardiovascular side effects associated with the hydrochlorothiazide component have included cardiac arrhythmias, including ventricular ectopy and complete AV heart block associated with hypokalemia and hyponatremia due to hydrochlorothiazide. Hydrochlorothiazide has also been reported to cause pulmonary edema and syncope. Cardiovascular side effects associated with the valsartan component have included dizziness related to orthostatic hypotension and (rarely) palpitations, and chest pain.

Dermatologic

Dermatologic side effects have included pruritus, hyperhidrosis, and rash. Dermatologic side effects associated with the amlodipine component have included angioedema, erythema multiforme, rash erythematosus, and rash maculopapular. Dermatologic side effects associated with the hydrochlorothiazide component have included erythema annular centrifugum, acute eczematous dermatitis, morbilliform and leukocytoclastic vasculitis, phototoxic dermatitis, and a rare subacute lupus erythematosus-like reaction. Dermatologic side effects associated with the valsartan component have rarely been reported and include pruritus, rash and alopecia.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2.2%), nausea (2.1%), constipation, diarrhea, abdominal pain, vomiting, toothache, dry mouth, gastritis, increased appetite, anorexia, dehydration, and hemorrhoids. Gastrointestinal side effects associated with the amlodipine component have included anorexia, dysphagia, pancreatitis, and gingival hyperplasia. Gastrointestinal side effects associated with the hydrochlorothiazide component are rare, and include pancreatitis, nausea, and acute cholecystitis. Gastrointestinal side effects associated with the valsartan component have rarely been reported and include diarrhea, constipation, dry mouth, dyspepsia, anorexia, nausea, vomiting, taste disturbance, and flatulence.

General

General side effects have included asthenia, non-cardiac chest pain, chills, and malaise.

Hematologic

Hematologic side effects associated with the amlodipine component have included leucopenia, purpura, and thrombocytopenia. Hematologic side effects associated with the hydrochlorothiazide component have included aplastic anemia, agranulocytosis, and hemolytic anemia. Hematologic side effects associated with the valsartan component have been rare and have included decreases in hematocrit or hemoglobin, neutropenia, and thrombocytopenia.

Hepatic

Hepatic side effects have included blood creatine phosphokinase increased. Hepatic side effects associated with the amlodipine component have included hepatic enzyme elevations and jaundice. Hepatic side effects of the valsartan component have included elevated liver enzymes and very rare reports of hepatitis.

Hypersensitivity

Hypersensitivity side effects associated with the amlodipine component have included at least one case of erythema multiforme. Hypersensitivity side effects associated with the hydrochlorothiazide component have included photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, and anaphylactic reactions.

Immunologic

Immunologic side effects have included nasopharyngitis (2.1%), respiratory tract infection, bronchitis, influenza, viral infection, tooth abscess, viral gastritis, and rhinitis.

Metabolic

Metabolic side effects have included edema (6.5%), weight loss, blood uric acid increased, blood creatine phosphokinase increased, hypokalemia, diabetes mellitus, hyperlipidemia, hyponatremia, and night sweats. Metabolic side effects associated with the amlodipine component have included hot flushes, malaise, rigors, hyperglycemia, thirst, and weight gain. Metabolic side effects associated with the hydrochlorothiazide component have included glycosuria and hyperuricemia. Metabolic side effects associated with the valsartan component have included hyperkalemia in 4.4% of patients.

Musculoskeletal

Musculoskeletal side effects have included muscle spasms (2.2%), back pain (2.1%), pain in extremity, arthralgia, muscular weakness, musculoskeletal pain and weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, and tendonitis. Musculoskeletal side effects associated with the amlodipine component have included arthrosis, and muscle cramps. Musculoskeletal side effects associated with the hydrochlorothiazide component are unusual, and include myalgias and chills. Musculoskeletal side effects associated with the valsartan component have included back pain, muscle cramps, and myalgias. In addition, rare reports of rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Nervous system

Nervous system side effects have included dizziness (8.2%), headache (5.2%), fatigue (2.2%), vertigo, paresthesia, somnolence, syncope, carpal tunnel syndrome, disturbance in attention, dysgeusia, head discomfort, lethargy, sinus headache, and tremor. Nervous system side effects associated with the amlodipine component have included peripheral neuropathy, tremor, and increased sweating. Nervous system side effects associated with the hydrochlorothiazide component have included restlessness. Nervous system side effects associated with the valsartan component have included headaches, orthostatic effects, including dizziness, and vertigo. These side effects appear to be dose dependent and have reportedly been the most common reasons for discontinuation of therapy.

Ocular

Ocular side effects have included blurred vision. Ocular side effects associated with the amlodipine component have included abnormal vision, conjunctivitis, diplopia, and eye pain. Ocular side effects associated with the hydrochlorothiazide component have included transient blurred vision, xanthopsia, and idiosyncratic reactions resulting in acute transient myopia and acute angle-closure glaucoma.

Other

Other side effects have included ear and labyrinth disorders, and tinnitus. Other side effects associated with the amlodipine component have included tinnitus.

Psychiatric

Psychiatric side effects have included anxiety, depression, and insomnia. Psychiatric side effects associated with the valsartan component have included anxiety, insomnia, paresthesia, and somnolence.

Renal

Renal side effects associated with the amlodipine component are rare and have included at least one case of interstitial nephritis. Renal side effects associated with the hydrochlorothiazide component have included an increase in serum creatinine and BUN which may be due to hydrochlorothiazide-induced intravascular volume depletion. Rare cases of interstitial nephritis have also been reported with hydrochlorothiazide use. Renal side effects associated with the valsartan component have included impaired renal function, increases in serum creatinine concentrations, blood urea nitrogen, and potassium.

Respiratory

Respiratory side effects have included dyspnea, nasal congestion, cough, and pharyngolaryngeal pain. Respiratory side effects associated with the amlodipine component have included sexual dysfunction (male and female), nervousness, abnormal dreams, and depersonalization. Respiratory side effects associated with the hydrochlorothiazide component have been rare, and included acute noncardiogenic pulmonary edema. Respiratory side effects associated with the valsartan component have included sinusitis and pharyngitis.

Genitourinary

Genitourinary side effects have included urinary tract infection, erectile dysfunction, dysuria, and pollakiuria. Genitourinary side effects associated with the amlodipine component have included micturition frequency, micturition disorder, and nocturia. Genitourinary side effects associated with the valsartan component have included rare reports of impotence.

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