Twynsta Side Effects

Generic name: amlodipine / telmisartan

Note: This document contains side effect information about amlodipine / telmisartan. Some of the dosage forms listed on this page may not apply to the brand name Twynsta.

Some side effects of Twynsta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amlodipine / telmisartan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amlodipine / telmisartan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, amlodipine and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have:

• feeling like you might pass out;

• swelling in your hands or feet, rapid weight gain;

• new or worsened chest pain;

• pounding heartbeats or fluttering in your chest;

Common side effects may include:

• dizziness, drowsiness;

• tired feeling;

• flushing (warmth, redness, or tingly feeling);

• back pain; or

• nausea, diarrhea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amlodipine / telmisartan: oral tablet

Cardiovascular

Cardiovascular side effects have included peripheral edema (4.8%), and orthostatic hypotension (6.3%). Cardiovascular side effects associated with amlodipine have included palpitation (up to 4.5%) and peripheral edema (2%). Peripheral edema may become a chronic problem, and may occur in up to 10% of patients who are receiving 10 mg doses. Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural dizziness, postural hypotension, syncope, tachycardia, and vasculitis have been reported (less than 1%). Cardiac failure, extrasystoles, and pulse irregularity have been reported (less than 0.1%). Angina and myocardial infarction have occasionally been reported; however, these reactions could not be distinguished from coexisting disease states or medications. Worsened angina has been rarely associated with the use of amlodipine (as with other calcium channel blockers). Cardiovascular side effects associated with telmisartan (and other angiotensin II receptor inhibitors) have included dizziness (related to orthostatic hypotension). Palpitations, chest pain, and angioedema have been reported rarely. Angioedema and urticaria have been reported in postmarketing experience. Hypertension, chest pain, peripheral edema, palpitations, tachycardia, and abnormal ECG findings have been reported (less than 1%). Stroke has been reported rarely. A case of myocardial infarction was reported. Dependent edema, angina, abnormal ECG findings, hypertension, cerebrovascular disorder, and peripheral edema have been reported. Atrial fibrillation, bradycardia, congestive heart failure, myocardial infarction, increased blood pressure, aggravated hypertension, and hypotension (including postural hypotension) have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects associated with amlodipine have included rash and erythematous rash (2%), angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus (less than 1%). Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported (less than 0.1%). Amlodipine-associated lichen planus and telangiectasia have been rarely reported. Dermatologic side effects associated with telmisartan have been rarely reported and have included pruritus, rash, eczema, and general dermatitis.

Endocrine

Endocrine side effects associated with amlodipine have included gynecomastia during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects associated with amlodipine have included nausea (2.9%), dysphagia (2%), and abdominal pain (1.6%). Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, and vomiting have been reported (less than 1%). Gastritis, increased appetite, loose stools, change in bowel habits, and taste perversion have been reported (less than 0.1%). At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge. Gastrointestinal side effects associated with telmisartan have included diarrhea (3%). Flatulence, abdominal pain, nausea, constipation, gastritis, vomiting, dry mouth, dyspepsia, hemorrhoids, gastroenteritis, enteritis, and gastroesophageal reflux have been reported (less than 1%). A case of pancreatitis has been reported. Cholecystitis and cholelithiasis have been reported.

Genitourinary

Genitourinary side effects associated with amlodipine have included micturition disorder, micturition frequency, and nocturia (less than 1%). Dysuria and polyuria have been reported (less than 0.1% ). Both male and female sexual dysfunction has been reported (2%). Genitourinary side effects associated with telmisartan have been reported rarely. Impotence, urinary frequency, and cystitis have been reported. Endometriosis has been reported. Urinary tract infection and erectile dysfunction have been reported during postmarketing experience.

Hematologic

Hematologic side effects associated with amlodipine have included leukopenia, purpura, and thrombocytopenia (less than 1%). Hematologic side effects associated with telmisartan have included anemia and granuloma. Eosinophilia and thrombocytopenia have been reported in postmarketing studies.

Hepatic

Hepatic side effects associated with amlodipine have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience. In some instances, these cases were severe enough to require hospitalization. Hepatic side effects associated with telmisartan have rarely included elevations of serum hepatic enzymes at rates slightly greater than placebo. Abnormal hepatic function and liver disorder have been reported in postmarketing studies.

Hypersensitivity

Hypersensitivity side effects associated with amlodipine have included at least one case of erythema multiforme. Hypersensitivity side effects associated with telmisartan have been reported rarely. A case of angioedema was reported. Edema (including face, lower limb, and angioneurotic edema), erythema, angioedema, and urticaria have been reported during postmarketing experience.

Metabolic

Metabolic side effects associated with amlodipine have included hyperglycemia and thirst (less than 1%). Metabolic side effects associated with telmisartan have included gout, hypercholesterolemia, and hyperglycemia (less than 1%). Hyperkalemia and increased uric acid have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included back pain (2.2%). Musculoskeletal side effects associated with amlodipine have included myalgia (2%), and arthralgia, arthrosis, and muscle cramps (less than 1%). Hypertonia, muscle weakness, and twitching have been reported (less than 0.1%). Musculoskeletal side effects associated with telmisartan have included back pain (3%). Arthritis, arthralgias, myalgias, and leg pain have been reported (less than 1%). Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers including telmisartan. Muscle cramps (including leg cramps), and tendon pain (including tendonitis and tenosynovitis), myalgia, peripheral ischemia, and elevated creatine phosphokinase (CPK) have also been reported during postmarketing experience.

Nervous system

Nervous system side effects have included dizziness (3%) and headache (1.4%). Nervous system side effects associated with amlodipine have included headache (7.3%), dizziness (3.4%), and somnolence (1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, tremor, and vertigo have been reported (less than 1%). Ataxia and migraine have been reported (less than 0.1%). Myoclonus has been reported. Nervous system side effects associated with telmisartan have included headache (1%). Dizziness, pain, fatigue, insomnia, somnolence, migraine, vertigo, tinnitus, earaches, paresthesias, involuntary muscle contractions, and hypoesthesia have been reported (less than 1%). Asthenia, weakness, and syncope have been reported during postmarketing experience.

Ocular

Ocular side effects associated with amlodipine have included abnormal vision, conjunctivitis, diplopia, and eye pain (less than 1%). Abnormal visual accommodation and xerophthalmia have been reported (less than 0.1%). Ocular side effects associated with telmisartan have rarely been reported and have included abnormal vision and conjunctivitis.

Other

Other side effects associated with amlodipine have included asthenia, hot flushes, malaise, pain, rigors, tinnitus, weight decrease, and weight gain (less than 1%). Cold and clammy skin and parosmia have been reported (less than 0.1%). A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition. Other side effects associated with telmisartan have included increased sweating, flushing, fever, malaise, infection, abscess, otitis media, tinnitus, earache, and toothache. Influenza-like symptoms have been reported.

Psychiatric

Psychiatric side effects associated with amlodipine have included abnormal dreams, anxiety, depersonalization, depression, insomnia, mood change, and nervousness (less than 1%). Agitation, amnesia, and apathy have been reported (less than 0.1%). Psychiatric side effects associated with telmisartan are rare and have included anxiety, depression, and nervousness.

Renal

Renal side effects associated with amlodipine are rare and have included at least one case of interstitial nephritis. Renal side effects associated with telmisartan are rare and have included oliguria, azotemia, and acute renal failure.

Respiratory

Respiratory side effects associated with amlodipine have included epistaxis (2%) and dyspnea (less than 1%). Coughing and rhinitis have been reported (less than 0.1%). Respiratory side effects associated with telmisartan have included upper respiratory infections, sinusitis, and pharyngitis (1 to 7%). Asthma, rhinitis, dyspnea, and epistaxis have also been reported. Cough has been reported during postmarketing experience. Acute sinusitis and bronchitis have been reported.

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