Applies to belzutifan: oral tablet.
Warning
Oral route (Tablet)
Warning: Embryo-fetal toxicityExposure to belzutifan during pregnancy can cause embryo-fetal harm.Verify pregnancy status prior to the initiation of belzutifan.Advise patients of these risks and the need for effective non-hormonal contraception. Belzutifan can render some hormonal contraceptives ineffective.
Serious side effects of Belzutifan
Along with its needed effects, belzutifan 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 belzutifan:
More common
- Blurred vision
- change in vision
- chest tightness
- confusion
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- headache
- hives, itching, skin rash
- nervousness
- pale skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects of Belzutifan
Some side effects of belzutifan 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
- Body aches or pain
- chills
- constipation
- difficulty in moving
- ear congestion
- fever
- loss of voice
- muscle aches, cramps, pain, or stiffness
- nausea
- pain in the joints
- sneezing
- sore throat
- stomach pain
- stuffy or runny nose
- swollen joints
- weight increased
For Healthcare Professionals
Applies to belzutifan: oral tablet.
General
The most common adverse reactions, including laboratory abnormalities, that occurred during treatment with this drug were anemia, decreased hemoglobin, fatigue, increased creatinine, dizziness, headache, increased glucose, and nausea.[Ref]
Cardiovascular
Very common (10% or more): Hypertension (up to 16%)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 36%), constipation (up to 21%), abdominal pain (up to 18%), diarrhea (15%)[Ref]
Hematologic
Very common (10% or more): Anemia (90%)[Ref]
Metabolic
Very common (10% or more): increased weight (up to 16%)[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (up to 25%), arthralgia (up to 21%), back pain (13%)[Ref]
Nervous system
Very common (10% or more): Headache (up to 44%), dizziness (up to 44%)[Ref]
Ocular
Very common (10% or more): Visual impairment (including blurred vision, central retinal vein occlusion, and retinal detachment) (up to 21%)[Ref]
Other
Very common (10% or more): Fatigue (up to 70%), peripheral edema (13%), Urinary tract infection (18%), upper respiratory tract infection (including bronchitis, sinusitis, viral upper respiratory infection) (up to 21%), increased creatinine (64%), increased glucose (34%), increased ALT (20%), increased AST (16%), decreased hemoglobin (93%), decreased leukocytes (11%)
Common (1% to 10%): Decreased corrected calcium, decreased phosphate[Ref]
Psychiatric
Very common (10% or more): Insomnia (13%), anxiety (11%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (up to 23%)[Ref]
