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Azilsartan medoxomil / chlorthalidone Side Effects

Not all side effects for azilsartan medoxomil / chlorthalidone 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 azilsartan medoxomil / chlorthalidone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by azilsartan medoxomil / chlorthalidone. 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 azilsartan medoxomil / chlorthalidone:

Less common
  • Blurred vision
  • confusion
  • convulsions
  • decreased urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Ankle, knee, or great toe joint pain
  • joint stiffness or swelling
  • lower back, side, or stomach pain
  • swelling of the feet or lower legs

Some of the side effects that can occur with azilsartan medoxomil / chlorthalidone 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
  • Dizziness
Rare
  • Cough
  • diarrhea
  • lack or loss of strength
  • muscle spasm
Incidence not known
  • Headache
  • loss of appetite
  • rash
  • stomach cramps

For Healthcare Professionals

Applies to azilsartan medoxomil / chlorthalidone: oral tablet

General

The most common side effects were dizziness and fatigue.[Ref]

Nervous system

Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope

Azilsartan:
Common (1% to 10%): Dizziness
Frequency not reported: Dizziness postural

Chlorthalidone:
Common (1% to 10%): Dizziness
Frequency not reported: Headache[Ref]

Other

Common (1% to 10%): Fatigue

Azilsartan:
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Asthenia

Chlorthalidone:
Common (1% to 10%): Fatigue[Ref]

Renal

Common (1% to 10%): Consecutive creatinine increases of 50% or greater from baseline and greater than the upper limit of normal

Azilsartan:
Uncommon (0.1% to 1%): Consecutive creatinine increases of 50% or greater from baseline and greater than the upper limit of normal

Chlorthalidone:
Uncommon (0.1% to 1%): Consecutive creatinine increases of 50% or greater from baseline and greater than the upper limit of normal[Ref]

Gastrointestinal

Postmarketing reports: Nausea

Azilsartan:
Frequency not reported: Diarrhea, nausea

Chlorthalidone:
Frequency not reported: Gastrointestinal upset[Ref]

Cardiovascular

Common (1% to 10%): Hypotension[Ref]

Dermatologic

Postmarketing reports: Rash, pruritus, angioedema

Chlorthalidone:
Frequency not reported: Rash[Ref]

Hepatic

Chlorthalidone:
Frequency not reported: Cholesterol elevated[Ref]

Metabolic

Frequency not reported: BUN increased

Chlorthalidone:
Frequency not reported: Uric acid elevated[Ref]

Musculoskeletal

Azilsartan:
Frequency not reported: Muscle spasm[Ref]

Respiratory

Azilsartan:
Frequency not reported: Cough[Ref]

References

1. "Product Information. Edarbyclor (azilsartan-chlorthalidone)." Takeda Pharmaceuticals America, Lincolnshire, IL.

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