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Amlodipine / telmisartan Side Effects

In Summary

Commonly reported side effects of amlodipine/telmisartan include: edema. Other side effects include: fatigue and palpitations. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to amlodipine / telmisartan: oral tablet

Along with its needed effects, amlodipine/telmisartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine / telmisartan:

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 side effects of amlodipine / telmisartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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

General

The most common side effect was peripheral edema.[Ref]

Other

Very common (10% or more): Peripheral edema (up to 11.3%)

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Vertigo, asthenia, fatigue

Rare (less than 0.1%): Malaise

Amlodipine:

Very common (10% or more): Peripheral edema (up to 17.8%), edema (10.8%)

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Vertigo, asthenia, malaise, pain, rigors, tinnitus, thirst

Frequency not reported: Gynecomastia

Telmisartan:

Uncommon (0.1% to 1%): Peripheral edema

Frequency not reported: Influenza-like symptoms, pain, fatigue, fever, malaise, dependent edema, vertigo, tinnitus, earache, blood creatine phosphokinase increased

Postmarketing reports: Asthenia, weakness, edema, face edema, lower limb edema[Ref]

Nervous system

Common (1% to 10%): Dizziness

Uncommon (0.1% to 1%): Somnolence, migraine, headache, paresthesia

Rare (less than 0.1%): Syncope, peripheral neuropathy, hypoesthesia, dysgeusia, tremor

Amlodipine:

Common (1% to 10%): Dizziness, headache, somnolence

Uncommon (0.1% to 1%): Syncope, postural dizziness, hypoesthesia, neuropathy peripheral, paresthesia, tremor

Frequency not reported: Ataxia, hypertonia, migraine, amnesia, parosmia, taste perversion

Telmisartan:

Frequency not reported: Headache, dizziness, somnolence, migraine, paresthesia, hypoesthesia, cerebrovascular disorder

Postmarketing reports: Syncope[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Arthralgia, muscle spasms, myalgia

Rare (less than 0.1%): Pain in extremity

Amlodipine:

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Arthralgia, arthrosis, muscle cramps, myalgia

Frequency not reported: Muscle weakness, twitching

Telmisartan:

Common (1% to 10%): Back pain

Frequency not reported: Myalgia, leg pain, involuntary muscle contractions, arthritis, arthralgia, leg cramps, tendon pain, tendonitis

Postmarketing reports: Muscle cramps, tenosynovitis, rhabdomyolysis[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Abdominal pain, diarrhea, nausea

Rare (less than 0.1%): Vomiting, gingival hypertrophy, dyspepsia, dry mouth

Amlodipine:

Common (1% to 10%): Nausea, abdominal pain, dysphagia

Uncommon (0.1% to 1%): Constipation, dyspepsia, diarrhea, flatulence, vomiting, gingival hyperplasia, change of bowel habit, dry mouth

Frequency not reported: Gastritis, loose stools

Telmisartan:

Common (1% to 10%): Diarrhea

Frequency not reported: Dyspepsia, abdominal pain, nausea, flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders, stomach discomfort[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus

Rare (less than 0.1%): Eczema, erythema, rash

Amlodipine:

Common (1% to 10%): Rash, rash erythematous

Uncommon (0.1% to 1%): Angioedema, erythema multiforme, pruritus, rash maculopapular, sweating increased, purpura

Frequency not reported: Skin discoloration, urticaria, skin dryness, alopecia, dermatitis, cold and clammy skin, hyperhidrosis, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity reaction

Telmisartan:

Very rare (less than 0.01): Angioedema

Frequency not reported: Increased sweating, dermatitis, rash, eczema, pruritus, urticaria, drug eruption, hyperhidrosis, toxic skin eruption

Postmarketing reports: Angioneurotic edema, erythema, toxicoderma[Ref]

Genitourinary

Uncommon (0.1% to 1%): Erectile dysfunction

Rare (less than 0.1%): Cystitis, nocturia

Amlodipine:

Common (1% to 10%): Sexual dysfunction

Uncommon (0.1% to 1%): Micturition frequency, micturition disorder, nocturia

Frequency not reported: Dysuria, polyuria, pollakiuria

Telmisartan:

Frequency not reported: Urinary tract infection, impotence, micturition frequency, cystitis

Postmarketing reports: Erectile dysfunction[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Bradycardia, palpitations, hypotension, orthostatic hypotension, flushing, chest pain

Amlodipine:

Common (1% to 10%): Flushing, palpitations

Uncommon (0.1% to 1%): Arrhythmia, bradycardia, chest pain, hypotension, peripheral ischemia, tachycardia, postural hypotension, vasculitis, hot flushes

Frequency not reported: Cardiac failure, pulse irregularity, extrasystoles, myocardial infarction, angina, ventricular tachycardia, atrial fibrillation

Telmisartan:

Frequency not reported: Hypertension, chest pain, flushing, palpitation, angina pectoris, tachycardia, abnormal ECG

Postmarketing reports: Atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension, bradycardia[Ref]

Respiratory

Uncommon (0.1% to 1%): Cough

Amlodipine:

Common (1% to 10%): Epistaxis

Uncommon (0.1% to 1%): Dyspnea

Frequency not reported: Coughing, rhinitis

Telmisartan:

Common (1% to 10%): Upper respiratory tract infection, sinusitis, pharyngitis, cough

Frequency not reported: Asthma, bronchitis, rhinitis, dyspnea, epistaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzymes increased

Amlodipine:

Uncommon (0.1% to 1%): Pancreatitis

Frequency not reported: Hepatitis, jaundice, hepatic enzyme elevations

Telmisartan:

Frequency not reported: Liver chemistries elevated, abnormal hepatic function[Ref]

Psychiatric

Rare (less than 0.1%): Depression, anxiety, insomnia

Amlodipine:

Uncommon (0.1% to 1%): Insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization, mood change

Frequency not reported: Apathy, agitation, confusional state

Telmisartan:

Frequency not reported: Insomnia, anxiety, depression, nervousness[Ref]

Metabolic

Rare (less than 0.1%): Blood uric acid increased

Amlodipine:

Uncommon (0.1% to 1%): Anorexia, weight gain, weight decrease, hyperglycemia

Frequency not reported: Increased appetite

Telmisartan:

Frequency not reported: Gout, hypercholesterolemia, diabetes mellitus, hyperkalemia, hypoglycemia

Postmarketing reports: Uric acid increased[Ref]

Ocular

Amlodipine:

Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain

Frequency not reported: Abnormal visual accommodation, xerophthalmia, visual impairment

Telmisartan:

Frequency not reported: Abnormal vision, conjunctivitis, visual disturbance[Ref]

Hematologic

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia

Telmisartan:

Uncommon (0.1% to 1%): Greater than 2 g/dL decrease in hemoglobin

Frequency not reported: Anemia, thrombocytopenia, hemoglobin decreased[Ref]

Immunologic

Amlodipine:

Uncommon (0.1% to 1%): Allergic reaction

Frequency not reported: Hypersensitivity

Telmisartan:

Frequency not reported: Allergy, infection, fungal infection, abscess, otitis media, sepsis, eosinophilia, anaphylactic reaction, hypersensitivity[Ref]

Renal

Telmisartan:

Uncommon (0.1% to 1%): 0.5 mg/dL or greater rise in creatinine

Frequency not reported: BUN increased, renal impairment, acute renal failure, blood creatinine increased[Ref]

References

1. "Product Information. Twynsta (amlodipine-telmisartan)." Boehringer-Ingelheim, Ridgefield, CT.

2. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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