Applies to telmisartan: oral tablet.

Serious side effects of Telmisartan

Along with its needed effects, 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 telmisartan:

Rare

• Changes in vision
• dizziness, lightheadedness, or fainting
• fast heartbeat
• large hives
• painful urination or changes in urinary frequency
• swelling in the hands, lower legs, and feet

Incidence not known

• Blurred vision
• chest pain or discomfort
• confusion
• dark-colored urine
• decreased urine output
• dilated neck veins
• extreme fatigue
• flushing
• hives or welts
• hoarseness
• irregular breathing
• irritation
• itching
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps or stiffness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• rash
• redness of the skin
• slow, fast, or irregular heartbeat
• sweating
• swelling of the eyelids, face, or lips
• tightness in the chest
• trouble breathing or swallowing
• trouble with speaking or walking
• trouble with thinking
• unusual tiredness or weakness
• unusually warm skin
• weakness or heaviness of the legs
• weakness, numbness, or tingling in the arms or legs
• weight gain

Other side effects of Telmisartan

Some side effects of 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

• Abdominal or stomach pain
• back pain
• bloating or gas
• changes in appetite
• coughing
• diarrhea
• dry mouth
• ear pain or hearing problems
• fever
• general tiredness or weakness
• headache
• heartburn
• increased sweating
• muscle pain or spasm
• nausea
• nervousness
• runny or stuffy nose
• sneezing
• sore throat

Incidence not known

• Acid or sour stomach
• belching
• decreased interest in sexual intercourse
• difficulty with moving
• inability to have or keep an erection
• indigestion
• joint pain
• lack or loss of strength
• leg cramps
• loss in sexual ability, desire, drive, or performance
• muscle aching
• stomach discomfort or upset
• swelling
• weakness

For Healthcare Professionals

Applies to telmisartan: oral tablet.

General

The most common adverse events reported in hypertension trials were back pain, sinusitis, and diarrhea. The most common adverse events reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer.^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dyspepsia, nausea, abdominal pain

Uncommon (0.1% to 1%): Flatulence, vomiting, dry mouth, stomach discomfort, constipation, gastritis, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, palpitation, intermittent claudication, hypertension

Uncommon (0.1% to 1%): Bradycardia, orthostatic hypotension, tachycardia, angina pectoris, flushing, dependent edema, abnormal ECG

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

Respiratory

Common (1% to 10%): Coughing, upper respiratory tract infection, sinusitis, pharyngitis, bronchitis

Uncommon (0.1% to 1%): Dyspnea, asthma, epistaxis, rhinitis

Very rare (less than 0.01%): Interstitial lung disease^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, arthralgia, muscle spasms

Uncommon (0.1% to 1%): Gout, pain in extremity, arthritis

Rare (less than 0.1%): Tendon pain, blood creatine phosphokinase increased

Postmarketing reports: Rhabdomyolysis^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression

Uncommon (0.1% to 1%): Nervousness^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Syncope, somnolence, migraine, paresthesia, hypoesthesia, cerebrovascular disorder

Rare (less than 0.1%): Dysgeusia^[Ref]

Dermatologic

Common (1% to 10%): Rash, skin ulcer

Uncommon (0.1% to 1%): Pruritus, hyperhidrosis, eczema, dermatitis, sweating increased

Rare (less than 0.1%): Erythema, urticaria, drug eruption, toxic skin eruption^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Micturition frequency, impotence, cystitis

Postmarketing reports: Erectile dysfunction^[Ref]

Other

Common (1% to 10%): Pain, fatigue, influenza-like illness, chest pain, peripheral edema

Uncommon (0.1% to 1%): Vertigo, asthenia, tinnitus, earache, malaise, fever, leg edema

Postmarketing reports: Face edema^[Ref]

Immunologic

Uncommon (0.1% to 1%): Infection, fungal infection, abscess, otitis media, allergy, sepsis

Rare (less than 0.1%): Anaphylactic reaction, angioedema, hypersensitivity

Postmarketing reports: Angioneurotic edema^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperkalemia, hypercholesterolemia, diabetes mellitus

Rare (less than 0.1%): Hypoglycemia in diabetic patients^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, hemoglobin decreased

Rare (less than 0.1%): Eosinophilia, thrombocytopenia^[Ref]

Renal

Uncommon (0.1% to 1%): Renal impairment including acute renal failure, blood creatinine increased

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

Frequency not reported: Acute renal failure^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, visual disturbance^[Ref]

Hepatic

Rare (less than 0.1%): Hepatic function abnormal/liver disorder, hepatic enzyme increased^[Ref]