Twynsta Side Effects

Generic Name: amlodipine / telmisartan

Note: This page contains side effects data for the generic drug amlodipine / telmisartan. It is possible that some of the dosage forms included below may not apply to the brand name Twynsta.

It is possible that some side effects of Twynsta may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to amlodipine / telmisartan: oral tablet

As well as its needed effects, amlodipine / telmisartan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking amlodipine / telmisartan, check with your doctor immediately:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • cough
  • difficulty breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • rapid weight gain
  • runny nose
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • nervousness
  • pounding in the ears
  • shivering
  • slow or fast heartbeat
  • sweating
  • trouble sleeping
  • vomiting
Rare
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest tightness or heaviness
  • cold sweats
  • confusion
  • constipation
  • cough or hoarseness
  • dark urine
  • difficult or labored breathing
  • difficulty swallowing
  • dry mouth
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • flushed, dry skin
  • fruit-like breath odor
  • hives
  • increased hunger
  • increased sweating
  • increased thirst
  • increased volume of pale, dilute urine
  • irregular heartbeat
  • irritation in the mouth
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness, dizziness, or fainting
  • loss of consciousness
  • muscle cramps or stiffness
  • pale, bluish-colored, or cold hands or feet
  • pinpoint red spots on the skin
  • rash
  • redness and swelling of the gums
  • redness, soreness, or itching skin
  • severe or sudden headache
  • sudden loss of coordination
  • sudden slurring of speech
  • swollen glands
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • unexplained weight loss
  • unusual bleeding or bruising
  • vomiting of blood
  • weakness in the arms, hands, legs, or feet
  • weight gain
  • yellow eyes or skin

Some amlodipine / telmisartan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • heartburn
  • indigestion
  • pain or tenderness around the eyes and cheekbones
  • sleepiness or unusual drowsiness
Rare
  • Abnormal dreams
  • ankle, knee, or great toe joint pain
  • anxiety
  • bad, unusual, or unpleasant (after) taste
  • bleeding after defecation
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody nose
  • burning feeling in the chest or stomach
  • burning, dry, or itching eyes
  • changes in vision
  • cold and clammy skin
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough producing mucus
  • cracked, dry, or scaly skin
  • decreased sexual performance or desire
  • depression
  • dry mouth
  • earache
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • feeling of warmth
  • full feeling
  • hair loss or thinning of the hair
  • headache, severe and throbbing
  • hearing loss
  • hives or welts
  • hyperventilation
  • inability to have or keep an erection
  • increased appetite
  • irritability
  • lack of feeling or emotion
  • lack or loss of strength
  • loose stools
  • loss of memory
  • redness of the skin
  • redness or swelling in the ear
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • tenderness in the stomach area
  • toothache
  • uncomfortable swelling around the anus

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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