Note: This document contains side effect information about peanut allergen powder. Some dosage forms listed on this page may not apply to the brand name Palforzia.
Applies to peanut allergen powder: oral capsule sprinkle therapy pack, oral packet.
Warning
- Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
- The first dose and all dose increases will be given in a doctor's office or other healthcare setting.
- Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Be sure you know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.
- Do not take this drug if you have very bad asthma or asthma that is not controlled.
Serious side effects of Palforzia
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Trouble swallowing or speaking.
- Pain with swallowing.
- Heartburn.
- Chest pain or pressure, a fast heartbeat, or passing out.
- Dizziness.
- Flushing.
- Shortness of breath.
- Severe diarrhea.
- Stomach cramps.
Other side effects of Palforzia
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Stomach pain.
- Upset stomach or throwing up.
- Itching in the ear, mouth, or tongue.
- Numbness or tingling in the mouth.
- Throat irritation.
- Cough.
- Runny nose.
- Sneezing.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to peanut allergen powder: oral capsule, oral powder.
Hypersensitivity
Common (1% to 10%): Anaphylactic reaction[Ref]
Respiratory
Very common (10% or more): Throat irritation (40.3%), cough (31.9%), rhinorrhea (20.9%), sneezing (20.2%), throat tightness (14.1%), wheezing (12.3%)
Common (1% to 10%): Dyspnea[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (67.1%), vomiting (36.5%), nausea (32.3%), oral paresthesia (13.6%)[Ref]
Other
Common (1% to 10%): Ear pruritus[Ref]
Dermatologic
Very common (10% or more): Pruritus (32.5%), urticaria (28.4%)[Ref]
