Telmisartan

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

• Twynsta^® (containing Amlodipine, Telmisartan)

MICARDIS®
(my-CAR-dis)
(telmisartan) Tablets

Read this Patient Information before you start taking MICARDIS tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about MICARDIS tablets?

MICARDIS can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking MICARDIS, tell your doctor right away.

What is MICARDIS?

MICARDIS is a prescription medicine used:

• to treat high blood pressure (hypertension)
• in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death

It is not known if MICARDIS is safe and effective in children.

Who should not take MICARDIS?

You should not take MICARDIS tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.

For patients with diabetes, if you are taking MICARDIS you should not take aliskiren.

What should I tell my doctor before taking MICARDIS tablets?

Before you take MICARDIS tablets, tell your doctor if you:

• have liver problems
• have kidney problems
• have heart problems
• have any other medical conditions
• are pregnant or are planning to become pregnant. See “What is the most important information I should know about MICARDIS tablets?”
• are breast-feeding or plan to breast-feed. It is not known if MICARDIS passes into your breast milk. You and your doctor should decide if you will take MICARDIS tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take MICARDIS tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

For patients with diabetes, if you are taking MICARDIS you should not take aliskiren.

MICARDIS may affect the way other medicines work, and other medicines may affect how MICARDIS works. Especially tell your doctor if you take:

• aliskiren
• digoxin (Lanoxin®, Lanoxicaps®)
• lithium (Eskalith®, Lithobid®)
• medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
• ramipril (Altace®) or other medicines used to treat your high blood pressure or heart problem
• water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take MICARDIS tablets?

• Take MICARDIS tablets exactly as your doctor tells you to take it.
• Your doctor will tell you how much MICARDIS to take and when to take it.
• Do not change your dose unless your doctor tells you to.
• Take MICARDIS one time each day at the same time.
• Take MICARDIS tablets with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much MICARDIS, call your doctor, or go to the nearest hospital emergency room right away.
• Read the “How to Open the Blister” at the end of this leaflet before you use MICARDIS. Talk with your doctor if you do not understand the instructions.

What are the possible side effects of MICARDIS tablets?

MICARDIS tablets may cause serious side effects, including:

• Injury or death to your unborn baby. See “What is the most important information I should know about MICARDIS tablets?”
• Low blood pressure (hypotension) is most likely to happen if you also:
  • take water pills (diuretics)
  • are on a low-salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea
    If you feel faint or dizzy, lie down and call your doctor right away.
• Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of MICARDIS tablets. Call your doctor if you get:
  • swelling in your feet, ankles, or hands
  • unexplained weight gain
    Call your doctor right away if you get any of the symptoms listed above.
• High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

• swelling of the face, tongue, throat
• difficulty breathing
• skin rash

The most common side effects of MICARDIS tablets include:

• sinus pain and congestion (sinusitis)
• back pain
• diarrhea

These are not all the possible side effects with MICARDIS tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store MICARDIS tablets?

• Store MICARDIS tablets between 59°F to 86°F (15°C to 30°C).
• Do not remove MICARDIS tablets from blisters until right before you take them.

Keep MICARDIS tablets and all medicines out of the reach of children.

General information about MICARDIS tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MICARDIS tablets for a condition for which it was not prescribed. Do not give MICARDIS tablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about MICARDIS tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about MICARDIS tablets that is written for health professionals.

For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1800-459-9906.

What are the ingredients in MICARDIS tablets?

Active Ingredient: telmisartan

Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. MICARDIS tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

What is Cardiovascular Risk?

Patients older than 55 years of age who have been diagnosed with blood vessel disease in the heart, legs, or brain (coronary, peripheral, or cerebral vascular disease) or diabetes with end organ damage (for example: kidney, heart, and brain) are at higher risk of cardiovascular events (for example: death from cardiovascular causes, stroke, and/or heart attack).

How to open the blister:

1. Tear (You may also use scissors to tear the blister apart)

2. Peel (Peel off the paper layer from the aluminum foil)

3. Push (Push the tablet through the foil)

Telmisartan is part of the drug class:

• ANGIOTENSIN II ANTAGONISTS, PLAIN

Serious side effects have been reported with telmisartan. See the “Drug Precautions” section.

Common side effects of telmisartan include the following:

• sinus pain and congestion (sinusitis)
• back pain
• diarrhea

This is not a complete list of telmisartan side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take telmisartan with or without food.

Do not crush, chew, or break a telmisartan tablet. Swallow it whole.

Keep each tablet in its blister pack until you are ready to take it. Tear or cut the blister apart from the rest of the package and peel back the paper liner. Push the tablet through the foil to remove it.

It may take 2 to 4 weeks before your symptoms improve. Keep using the medicine as directed and tell your doctor if your symptoms do not improve.

Your blood pressure will need to be checked often.

You may have very low blood pressure while taking telmisartan. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store telmisartan tablets in their original package at room temperature, away from moisture and heat.

• When telmisartan is used in fixed combination with amlodipine or hydrochlorothiazide, advise patients of important precautionary information about the concomitant agent.2 132

• Risks of use during pregnancy.1 2 49 50

• Importance of instructing patients not to remove tablets from the blister package until immediately before administration.1 2 129 132

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 2

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2

• Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

In addition to taking telmisartan, treatment for your high blood pressure may include weight control and a change in the foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that telmisartan will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

telmisartan comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take telmisartan with or without food.

telmisartan works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the dose at the same time each day.

Dosing

The dose of telmisartan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of telmisartan. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • To lower the risk of heart attacks or stroke:
    • Adults—80 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of telmisartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the tablets from moisture. Do not remove them from the blister pack until you are ready to take a dose.

• Tell all of your health care providers that you take telmisartan. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are taking telmisartan and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Talk with your doctor before you drink alcohol.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• This medicine may not work as well in black patients. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Dizziness or passing out.
• Swelling in the arms or legs.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Aliskiren: Do not co-administer aliskiren with Telmisartan in patients with diabetes. Avoid use of aliskiren with Telmisartan in patients with renal impairment (GFR <60 mL/min).

Digoxin: When Telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing Telmisartan for the purpose of keeping the digoxin level within the therapeutic range.

Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Telmisartan. Therefore, monitor serum lithium levels during concomitant use.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Telmisartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

Ramipril and Ramiprilat: Co-administration of Telmisartan 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3- and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4- and 1.5-fold, respectively. In contrast, Cmax and AUC of Telmisartan decrease by 31% and 16%, respectively. When co-administering Telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of Telmisartan. Concomitant use of Telmisartan and ramipril is not recommended.

Other Drugs: Co-administration of Telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

Telmisartan is a non-peptide angiotensin II receptor (type AT1) antagonist.

Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:

Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.

 Telmisartan tablets, USP, are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of Telmisartan, USP. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, mannitol, and magnesium stearate. Telmisartan tablets are hygroscopic and require protection from moisture.

Read this Patient Information before you start taking Telmisartan tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Telmisartan tablets?

Telmisartan tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Telmisartan tablets, tell your doctor right away.

What aretelmisartan tablets?

Telmisartan tablets are prescription medicines used:

• to treat high blood pressure (hypertension)

It is not known if Telmisartan tablets are safe and effective in children.

Who should not take telmisartan tablets?

You should not take Telmisartan tablets if you are allergic (hypersensitive) to the active ingredient (Telmisartan) or any of the other ingredients listed at the end of this leaflet.

For patients with diabetes, if you are taking Telmisartan tablets you should not take aliskiren.

What should I tell my doctor before taking Telmisartan tablets?

Before you take Telmisartan tablets, tell your doctor if you:

• have liver problems
• have kidney problems
• have heart problems
• have any other medical conditions
• are pregnant or are planning to become pregnant. See "What is the most important information I should know about Telmisartan tablets?"
• are breast-feeding or plan to breast-feed. It is not known if Telmisartan passes into your breast milk. You and your doctor should decide if you will take Telmisartan tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Telmisartan tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

For patients with diabetes, if you are taking Telmisartan tablets you should not take aliskiren.

Telmisartan tablets may affect the way other medicines work, and other medicines may affect how Telmisartan tablets work. Especially tell your doctor if you take:

• aliskiren
• digoxin (Lanoxin®, Lanoxicaps®)
• lithium (Eskalith®, Lithobid®)
• medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
• ramipril (Altace®) or other medicines used to treat your high blood pressure or heart problem
• water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Telmisartan tablets?

• Take Telmisartan tablets exactly as your doctor tells you to take it.
• Your doctor will tell you how many Telmisartan tablets to take and when to take it.
• Do not change your dose unless your doctor tells you to.
• Take Telmisartan tablets one time each day at the same time.
• Take Telmisartan tablets with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too many Telmisartan tablets, call your doctor, or go to the nearest hospital emergency room right away.

What are the possible side effects of Telmisartan tablets?

Telmisartan tablets may cause serious side effects, including:

• Injury or death to your unborn baby. See "What is the most important information I should know about Telmisartan tablets?"
• Low blood pressure (hypotension) is most likely to happen if you also:
  • take water pills (diuretics)
  • are on a low-salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea

If you feel faint or dizzy, lie down and call your doctor right away.

• Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of Telmisartan tablets. Call your doctor if you get:
  • swelling in your feet, ankles, or hands
  • unexplained weight gain

Call your doctor right away if you get any of the symptoms listed above.

• High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.

 Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

• swelling of the face, tongue, throat
• difficulty breathing
• skin rash

The most common side effects of Telmisartan tablets include:

• sinus pain and congestion (sinusitis)
• back pain
• diarrhea

These are not all the possible side effects with Telmisartan tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Telmisartan tablets?

• Store Telmisartan tablets between 68°F to 77°F (20°C to 25°C).
• Keep bottle tightly closed. Tablets should not be removed from bottle until immediately before administration.

Keep Telmisartan tablets and all medicines out of the reach of children.

General information about Telmisartan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Telmisartan tablets for a condition for which it was not prescribed. Do not give Telmisartan tablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Telmisartan tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Telmisartan tablets that is written for health professionals.

For more information, call Solco Healthcare US, LLC at 1-866-257-2597.

What are the ingredients in Telmisartan tablets?

Active Ingredient: Telmisartan, USP

Inactive Ingredients: sodium hydroxide, meglumine, povidone, mannitol, and magnesium stearate

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Telmisartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

Trademarks are the property of their respective owners.

Distributed by:       Solco Healthcare US, LLC

                                 Cranbury, NJ 08512, USA

Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.

                                Xunqiao, Linhai, Zhejiang 317024, China

Revised: 06/2017

17555-01

Angiotensin II acts as a vasoconstrictor. In addition to causing direct vasoconstriction, angiotensin II also stimulates the release of aldosterone. Once aldosterone is released, sodium as well as water is reabsorbed. The end result is an elevation in blood pressure. Telmisartan is a nonpeptide AT1 angiotensin II receptor antagonist. This binding prevents angiotensin II from binding to the receptor thereby blocking the vasoconstriction and the aldosterone secreting effects of angiotensin II.

Distribution

Vd: 500 L

Metabolism

Hepatic via conjugation to inactive metabolites; not metabolized via CYP

Excretion

Feces (97%)

Clearance: Total body: 800 mL/minute

Hypertension: Oral: Initial: 40 mg once daily; usual dosage range (ASH/ISH [Weber, 2014]): 40 to 80 mg daily. Patients with volume depletion should be initiated on the lower dosage with close supervision

Cardiovascular risk reduction: Oral: 80 mg once daily. Note: It is unknown whether doses <80 mg daily are associated with a reduction in risk of cardiovascular morbidity or mortality.

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]

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