Ninlaro Side Effects
Generic name: ixazomib
Medically reviewed by Drugs.com. Last updated on Jul 8, 2023.
Note: This document contains side effect information about ixazomib. Some dosage forms listed on this page may not apply to the brand name Ninlaro.
Applies to ixazomib: oral capsule.
Serious side effects of Ninlaro
Along with its needed effects, ixazomib (the active ingredient contained in Ninlaro) 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 ixazomib:
- Black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- burning, numbness, tingling, or painful sensations
- dark urine
- itching or rash
- light-colored stools
- loss of appetite
- lower back or side pain
- numbness, tingling, or pain in the hands or feet
- painful or difficult urination
- pale skin
- rapid weight gain
- rash with flat lesions or small raised lesions on the skin
- redness or discoloration of the skin
- sore throat
- stomach pain
- tingling of the hands or feet
- ulcers, sores, or white spots in the mouth
- unpleasant breath odor
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting of blood
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
- Bleeding gums
- blood in the urine or stools
- pinpoint red spots on the skin
- Blistering, peeling, or loosening of the skin
- bloody nose
- heavier menstrual periods
- joint or muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
Other side effects of Ninlaro
Some side effects of ixazomib 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:
- Back pain
- blurred vision
- body aches or pain
- burning, dry, or itching eyes
- difficulty having a bowel movement (stool)
- discharge, excessive tearing
- ear congestion
- loss of voice
- nasal congestion
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
For Healthcare Professionals
Applies to ixazomib: oral capsule.
The most common adverse reactions were thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, upper respiratory tract infection, back pain, and bronchitis. Serious adverse reactions included diarrhea, thrombocytopenia, and bronchitis.
Very common (10% or more): Arrhythmia (up to 17%)
Very common (10% or more): Rash (up to 27%)
Rare (0.01% to 0.1%): Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet's syndrome)
Postmarketing reports: Stevens-Johnson syndrome
Rash was reported in up to 27% of patients receiving this drug regimen. Most rash adverse reactions were Grade 1 (15%) and Grade 2 (9%); Grade 3 rash was reported in 3% of patients. Serious adverse reactions of rash were reported in less than 1% of patients. The most common type of rash reported included maculopapular and macular rash.
Stevens-Johnson syndrome (including a fatal case) has been reported with this drug.
Very common (10% or more): Diarrhea (up to 52%), constipation (up to 35%), nausea (up to 32%), vomiting (up to 26%)
Very common (10% or more): Thrombocytopenia (includes thrombocytopenia, decreased platelet count; up to 85%), neutropenia (up to 74%)
Rare (0.01% to 0.1%): Thrombotic microangiopathy, thrombotic thrombocytopenic purpura
Frequency not reported: Hemolytic uremic syndrome
Postmarketing reports: Thrombotic microangiopathy
Thrombocytopenia (Grade 3: 17%; Grade 4: 13%) has been reported in patients receiving this drug regimen.
Very common (10% or more): Liver impairment (including enzyme changes; up to 11%), hepatotoxicity
Frequency not reported: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, cholestatic hepatitis
Very common (10% or more): Decreased appetite (up to 13%)
Common (1% to 10%): Hypokalemia (Grade 3 to 4)
Rare (0.01% to 0.1%): Tumor lysis syndrome
Very common (10% or more): Back pain (up to 27%)
Peripheral neuropathy adverse reactions (Grade 1: 18%; Grade 2: 11%; Grade 3: 2%) have been reported in patients receiving this drug regimen. The most commonly reported reaction was peripheral sensory neuropathy (24%); peripheral motor neuropathy was not commonly reported (less than 1%).
Very common (10% or more): Peripheral neuropathies (includes peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, peripheral sensorimotor neuropathy; up to 32%), peripheral sensory neuropathy (up to 24%)
Rare (0.01% to 0.1%): Posterior reversible encephalopathy disorders, transverse myelitis
Frequency not reported: Peripheral motor neuropathy
Very common (10% or more): Eye disorders (up to 38%), cataract (up to 15%)
Common (1% to 10%): Conjunctivitis, blurred vision, dry eye
Very common (10% or more): Fatigue (up to 28%), peripheral edema (up to 28%)
Common (1% to 10%): Herpes zoster, deaths
Peripheral edema was reported in 28% of patients receiving this drug regimen. Most peripheral edema adverse reactions were Grade 1 (18%) and Grade 2 (7%); Grade 3 peripheral edema was reported in 2% of patients.
Herpes zoster was reported in 6% of patients receiving this drug regimen. Antiviral prophylaxis was allowed at the health care provider's discretion. Patients treated with this drug regimen who received antiviral prophylaxis had a lower incidence (1%) of herpes zoster infection compared to those who did not receive prophylaxis (10%).
Very common (10% or more): Upper respiratory tract infection (up to 28%), bronchitis (up to 22%)
Frequency not reported: Fungal pneumonia, viral pneumonia
Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients receiving this drug regimen.
Frequently asked questions
- What is Ninlaro used for?
- How much does Ninlaro cost compared to other chemo drugs?
- Ninlaro vs Velcade, which is better?
- Is Ninlaro (ixazomib) a chemotherapy drug? How does it work?
- Does Ninlaro cause shingles (herpes zoster)?
- How effective is Ninlaro (ixazomib)?
More about Ninlaro (ixazomib)
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- Drug class: proteasome inhibitors
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Related treatment guides
1. Product Information. Ninlaro (ixazomib). Takeda Pharmaceuticals America. 2022.
2. Product Information. Ninlaro (ixazomib). Takeda Pharmaceuticals Australia Pty Ltd. 2022.
3. Product Information. Ninlaro (ixazomib). Takeda UK Ltd. 2022.
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.