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Hydrochlorothiazide / telmisartan Side Effects

In Summary

More frequently reported side effects include: dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to hydrochlorothiazide / telmisartan: oral tablet

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

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking hydrochlorothiazide / telmisartan:

Less common:
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • confusion
  • convulsions
  • decreased urine
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • sudden sweating
  • unusual tiredness or weakness
Less common or rare:
  • Chills
  • cold sweats
Rare:
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Severity: Minor

Some of the side effects that can occur with hydrochlorothiazide / 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:

More common:
  • Body aches or pain
  • cough
  • difficulty breathing
  • dizziness
  • ear congestion
  • fever
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
Less common:
  • Abdominal or stomach pain
  • acid or sour stomach
  • back pain
  • belching
  • cough producing mucus
  • diarrhea
  • heartburn
  • hoarseness
  • indigestion
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • pain or tenderness around the eyes and cheekbones
  • rash
  • shivering
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble sleeping
  • trouble swallowing
  • voice changes

For Healthcare Professionals

Applies to hydrochlorothiazide / telmisartan: oral tablet

General

The most common adverse effect was upper respiratory tract infection.[Ref]

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory tract infection, cough
Uncommon (0.1% to 1%): Dyspnea
Rare (less than 0.1%): Bronchitis, pharyngitis, respiratory distress, pneumonitis, pulmonary edema

Hydrochlorothiazide:
Very common (10% or more): Upper respiratory tract infection (10%)
Common (1% to 10%): Sinusitis
Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema

Telmisartan:
Common (1% to 10%): Sinusitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Cough
Frequency not reported: Asthma, rhinitis, dyspnea, epistaxis
Postmarketing reports: Interstitial lung disease[Ref]

Other

Common (1% to 10%): Fatigue, influenza-like symptoms, pain
Uncommon (0.1% to 1%): Chest pain

Hydrochlorothiazide:
Common (1% to 10%): Fatigue, influenza-like symptoms
Frequency not reported: Weakness, pyrexia

Telmisartan:
Common (1% to 10%): Fatigue, influenza-like symptoms
Uncommon (0.1% to 1%): Asthenia
Frequency not reported: Earache, fever, malaise, leg edema, peripheral edema, dependent edema, chest pain
Postmarketing reports: Weakness, edema, face edema, pain[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Syncope, paresthesia, vertigo

Hydrochlorothiazide:
Common (1% to 10%): Dizziness
Frequency not reported: Lightheadedness

Telmisartan:
Common (1% to 10%): Dizziness
Rare (less than 0.1%): Somnolence
Frequency not reported: Tinnitus, migraine, hypoesthesia, cerebrovascular disorder, vertigo, paresthesia, hypoesthesia, involuntary muscle contraction
Postmarketing reports: Headache, syncope[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea
Uncommon (0.1% to 1%): Dry mouth, flatulence
Rare (less than 0.1%): Abdominal pain, constipation, dyspepsia, vomiting, gastritis

Hydrochlorothiazide:
Common (1% to 10%): Diarrhea, nausea
Frequency not reported: Sialadenitis, pancreatitis, stomach discomfort, cramping, gastric irritation

Telmisartan:
Common (1% to 10%): Diarrhea, nausea
Rare (less than 0.1%): Stomach discomfort
Frequency not reported: Hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorder, flatulence, constipation, gastritis, dry mouth,
Postmarketing reports: Dyspepsia, abdominal pain[Ref]

Renal

Common (1% to 10%): BUN increased 11.2 mg/dL or greater, serum creatinine increased 0.5 mg/dL or greater

Hydrochlorothiazide:
Frequency not reported: Nephritis interstitial, renal dysfunction, renal failure

Telmisartan:
Uncommon (0.1% to 1%): Renal impairment, acute renal failure[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Erectile dysfunction
Frequency not reported: Impotence

Hydrochlorothiazide:
Frequency not reported: Glycosuria

Telmisartan:
Uncommon (0.1% to 1%): Urinary tract infection
Frequency not reported: Micturition frequency, cystitis, impotence
Postmarketing reports: Erectile dysfunction[Ref]

Hematologic

Common (1% to 10%): Hemoglobin decreased 2 g/dL or greater
Uncommon (0.1% to 1%): Hematocrit decreased 9% or more

Hydrochlorothiazide:
Frequency not reported: Aplastic anemia, hemolytic anemia, bone marrow depression, leukopenia, neutropenia, agranulocytosis, thrombocytopenia

Telmisartan:
Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Eosinophilia, thrombocytopenia, hemoglobin decreased[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, arrhythmias, hypotension, orthostatic hypotension

Hydrochlorothiazide:
Frequency not reported: Vasculitis necrotizing

Telmisartan:
Uncommon (0.1% to 1%): Bradycardia
Frequency not reported: Palpitation, angina pectoris, abnormal ECG, flushing, hypertension
Postmarketing reports: Atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension, postural hypotension[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, muscle spasm, myalgia
Rare (less than 0.1%): Arthralgia, muscle cramp, pain in limb, blood creatine phosphokinase increased
Frequency not reported: Leg pain, cramps in legs
Postmarketing reports: Exacerbation or activation of systemic lupus erythematosus

Hydrochlorothiazide:
Frequency not reported: Lupus-like syndrome, muscle spasm

Telmisartan:
Rare (less than 0.1%): Arthrosis, tendon pain, tendonitis, tenosynovitis
Frequency not reported: Arthritis, arthralgia, leg pain, leg cramps, myalgia
Postmarketing reports: Back pain, muscle cramps, creatine phosphokinase increased, rhabdomyolysis[Ref]

Metabolic

Uncommon (0.1% to 1%): Hypokalemia, blood uric acid increased
Rare (less than 0.1%): Hyperuricemia, hyponatremia

Hydrochlorothiazide:
Frequency not reported: Diabetes mellitus inadequate control, anorexia, appetite decreased, electrolyte imbalance, hypercholesterolemia, hyperglycemia, hypovolemia, triglycerides increased, hyperuricemia

Telmisartan:
Uncommon (0.1% to 1%): Hyperkalemia
Rare (less than 0.1%): Hypoglycemia in diabetic patients
Frequency not reported: Diabetes mellitus, gout, hypercholesterolemia
Postmarketing reports: Uric acid increased[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety
Rare (less than 0.1%): Depression, insomnia, sleep disorder

Hydrochlorothiazide:
Frequency not reported: Restlessness

Telmisartan:
Frequency not reported: Nervousness, insomnia, anxiety, depression[Ref]

Dermatologic

Rare (less than 0.1%): Angioedema, erythema, pruritus, rash, hyperhidrosis, urticaria
Frequency not reported: Sweating increased

Hydrochlorothiazide:
Frequency not reported: Photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, purpura, urticaria

Telmisartan:
Rare (less than 0.1%): Eczema, drug eruption, toxic skin eruption, toxicoderma, rash, angioedema
Frequency not reported: Dermatitis, sweating increased, pruritus
Postmarketing reports: Urticaria, erythema[Ref]

Hepatic

Rare (less than 0.1%): Abnormal hepatic function/liver disorder, hepatic enzyme increased
Frequency not reported: Serum bilirubin increased

Hydrochlorothiazide:
Frequency not reported: Jaundice hepatocellular, jaundice cholestatic

Telmisartan:
Postmarketing reports: Abnormal hepatic function/liver disorder[Ref]

Ocular

Rare (less than 0.1%): Visual disturbance, vision blurred

Hydrochlorothiazide:
Frequency not reported: Xanthopsia, acute myopia, acute angle-closure glaucoma, transient blurred vision

Telmisartan:
Frequency not reported: Conjunctivitis, abnormal vision[Ref]

Immunologic

Hydrochlorothiazide:
Frequency not reported: Anaphylactic reactions, hypersensitivity, allergy

Telmisartan:
Rare (less than 0.1%): Sepsis, hypersensitivity, anaphylactic reactions
Frequency not reported: Allergy, infection, fungal infection, abscess, otitis media[Ref]

References

1. "Product Information. Micardis (hydrochlorothiazide-telmisartan)" Boehringer-Ingelheim, Braintree, MA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

Not all side effects for hydrochlorothiazide / 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.

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