Amlodipine / telmisartan Side Effects

Not all side effects for amlodipine / telmisartan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amlodipine / telmisartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amlodipine / telmisartan. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with amlodipine / telmisartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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