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Osilodrostat Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 7, 2020.

For the Consumer

Applies to osilodrostat: oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, osilodrostat 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 osilodrostat:

More common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • confusion
  • cough
  • darkening of the skin
  • decreased urine
  • diarrhea
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • increased thirst
  • joint pain
  • loss of appetite
  • lower back or side pain
  • mental depression
  • mood changes
  • muscle pain or cramps
  • nausea
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pale skin
  • pounding in the ears
  • runny nose
  • seizures
  • shivering
  • skin rash
  • slow heartbeat
  • sore throat
  • sweating
  • swelling of the arms or legs
  • trouble sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Less common

  • Fainting
  • irregular heartbeat, recurrent

Side effects not requiring immediate medical attention

Some side effects of osilodrostat 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:

More common

  • Acne
  • anxiety
  • back pain
  • decreased appetite
  • depression
  • difficulty in moving
  • heartburn
  • increased hair growth, especially on the face
  • indigestion
  • muscle stiffness
  • stomach discomfort, upset, or pain
  • stuffy nose
  • thinning or loss of hair

For Healthcare Professionals

Applies to osilodrostat: oral tablet

Hematologic

Very common (10% or more): Anemia (10%)[Ref]

Immunologic

Very common (10% or more): Influenza (10%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (18%), back pain (15%), myalgia (12%)[Ref]

Metabolic

Very common (10% or more): Hypokalemia (12%), anorexia (12%)[Ref]

Psychiatric

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

Genitourinary

Very common (10% or more): Urinary tract infection (12%), blood testosterone increased (11%)[Ref]

Hepatic

Common (1% to 10%): Transaminases increased[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (20%), dizziness (14%), cough (10%)[Ref]

Other

Very common (10% or more): Fatigue (e.g., lethargy, asthenia) (39%), edema (e.g., edema peripheral, generalized edema, localized edema) (21%), pyrexia (11%)

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

Nervous system

Very common (10% or more): Headache (31%), dizziness (e.g., dizziness postural) (14%)[Ref]

Cardiovascular

Very common (10% or more): Hypotension (e.g., orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased) (12%)

Common (1% to 10%): Tachycardia, electrocardiogram QT prolongation, syncope[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., rash erythematous, rash generalized, rash maculopapular, rash papular) (15%)

Common (1% to 10%): Hirsutism, acne, alopecia[Ref]

Endocrine

Very common (10% or more): Adrenal insufficiency (e.g., glucocorticoid deficiency, adrenocortical insufficiency acute, steroid withdrawal syndrome, cortisol free urine decreased, cortisol decreased (43%), hypocortisolism (31%), blood corticotrophin increased (14%), hormone level abnormal (12%)

Frequency not reported: Elevations in adrenal hormone precursors and androgens[Ref]

Gastrointestinal

Very common (10% or more): Nausea (37%), vomiting (19%), diarrhea (15%), abdominal pain (e.g., abdominal pain upper, abdominal discomfort) (13%)

Common (1% to 10%): Dyspepsia, gastroenteritis[Ref]

References

1. "Product Information. Isturisa (osilodrostat)." Recordati Rare Diseases Inc, Lebanon, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.