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Generic Name: ivosidenib (EYE voe SID e nib)
Brand Names: Tibsovo
Tibsovo (ivosidenib) is used to treat acute myeloid leukemia with an isocitrate dehydrogenase-1 (IDH1) mutation. Includes Tibsovo side effects, interactions and indications.
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Drug Information:
Tibsovo (ivosidenib) targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of acute myeloid leukemia. Tibsovo is used to treat acute myeloid leukemia (AML). Tibsovo is used to treat AML in adults with an IDH1 mutation. Your doctor will test you for this gene. Ivosidenib is used when other treatments did not work or have stopped working. Tibsovo is also used in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems. Learn more

Tibsovo Side Effects

Tibsovo Side Effects

Note: This document contains side effect information about ivosidenib. Some of the dosage forms listed on this page may not apply to the brand name Tibsovo.

For the Consumer

Applies to ivosidenib: oral tablet


Oral route (Tablet)

Warning: Differentiation SyndromePatients treated with ivosidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

Along with its needed effects, ivosidenib (the active ingredient contained in Tibsovo) 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 ivosidenib:

More common

  • Blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chest pain
  • chills
  • confusion
  • cough
  • decreased urination
  • difficult or labored breathing
  • difficulty in moving
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • eye pain
  • fainting
  • fever
  • general feeling of illness
  • headache
  • irregular heartbeat, recurrent
  • joint pain, stiffness, or swelling
  • lower back, side, or stomach pain
  • muscle ache, cramps, pain, or stiffness
  • rapid weight gain
  • rash
  • sensation of pins and needles
  • sore throat
  • stabbing pain
  • swelling of your arms, feet, or lower legs
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness


  • Inability to move the arms and legs
  • sudden numbness and weakness in the arms and legs

Some side effects of ivosidenib 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

  • Cracked lips
  • decreased appetite
  • diarrhea
  • difficulty in swallowing
  • nausea
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • vomiting

For Healthcare Professionals

Applies to ivosidenib: oral tablet


Common (1% to 10%): Hemoglobin decreased (60%), leukocytosis (e.g., leukocytosis, hyperleukocytosis, increased white blood cell count) (38%)


Uncommon (0.1% to 1%): Guillain-Barre syndrome


Very common (10% or more): Arthralgia (e.g., arthralgia, back pain, musculoskeletal stiffness, neck pain, pain in extremity) (36%), myalgia (e.g., myalgia, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia intercostal) (18%)


Very common (10% or more): Sodium decreased (39%), magnesium decreased (38%), uric acid increased (32%), potassium decreased (31%), phosphate decreased (25%), decreased appetite (18%)

Common (1% to 10%): Tumor lysis syndrome


Very common (10% or more): Alkaline phosphatase increased (27%), aspartate aminotransferase increased (27%), bilirubin increased (16%), alanine aminotransferase increased (15%)


Very common (10% or more): Dyspnea (33%), cough (e.g., cough, productive cough, upper airway cough syndrome) (22%), differentiation syndrome (can be associated with other commonly reported events such as peripheral edema, leukocytosis, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonia, pericardial effusion, rash, fluid overload, tumor lysis syndrome, creatinine increased) (19%), pleural effusion (13%)


Very common (10% or more): Fatigue (39%), edema (e.g., peripheral edema, edema, fluid overload, fluid retention, face edema) (32%). pyrexia (23%)

Nervous system

Very common (10% or more): Headache (16%), neuropathy (e.g., ataxia, burning sensation, gait disturbance, Guillain-Barre syndrome, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, peripheral motor neuropathy, sensory disturbance) (12%)


Very common (10% or more): Creatinine increased (23%)


Very common (10% or more): Chest pain (e.g., angina pectoris, chest pain, chest discomfort, non-cardiac chest pain) (16%), hypotension (e.g., hypotension, orthostatic hypotension) (12%)

Common (1% to 10%): Electrocardiogram QT prolonged


Very common (10% or more): Rash (e.g., dermatitis acneiform, dermatitis, rash, rash maculo-papular, urticaria, rash erythematous, rash macular, rash pruritic, rash generalized, rash papular, skin exfoliation, skin ulcer) (26%)


Very common (10% or more): Diarrhea (38%), nausea (31%), mucositis (e.g., aphthous ulcer, esophageal pain, esophagitis, gingival pain, gingivitis, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, proctalgia, stomatitis) (28%), constipation (20%), vomiting (18%), abdominal pain (16%)

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Tibsovo