Applies to mixed grass pollens allergen extract: sublingual tablet sublingual, sublingual therapy pack.
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 will be given in a doctor's office.
- 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
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.
- Cough that does not go away.
- Severe diarrhea.
- Very upset stomach or throwing up.
- Stomach cramps.
- Very bad belly pain.
Other side effects
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:
- Itching in the ear, mouth, or tongue.
- Cough.
- Throat pain.
- Throat irritation.
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 mixed grass pollens allergen extract: sublingual tablet.
General
The most common side effects reported were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain.[Ref]
Hypersensitivity
Postmarketing reports: Anaphylactic reaction, oral allergy syndrome, angioedema[Ref]
Respiratory
Very common (10% or more): Throat irritation (22%)
Common (1% to 10%): Cough, oropharyngeal pain, pharyngeal edema, tonsillitis, upper respiratory tract infection, asthma, dysphonia
Postmarketing reports: Dyspnea, laryngeal edema, stridor, wheezing, exacerbation of asthma, oropharyngeal blistering[Ref]
Cardiovascular
Postmarketing reports: Flushing, eosinophilic myocarditis, palpitations, tachycardia, hypotension, circulatory collapse, pallor, peripheral vascular disorder, chest discomfort[Ref]
Dermatologic
Common (1% to 10%): Urticaria, atopic dermatitis
Postmarketing reports: Rash, pruritus[Ref]
Endocrine
Postmarketing reports: Autoimmune thyroiditis[Ref]
Gastrointestinal
Very common (10% or more): Oral pruritus (25.1%)
Common (1% to 10%): Mouth edema, tongue pruritus, lip edema, oral paresthesia, abdominal pain, dyspepsia, tongue edema, oral hypoesthesia, stomatitis, dysphagia, nausea, vomiting, esophageal pain, gastritis, gastroesophageal reflux, lip pruritus
Postmarketing reports: Diarrhea, eosinophilic esophagitis, salivary gland enlargement and/or hypersecretion, dry mouth, dry eye[Ref]
Hematologic
Postmarketing reports: Lymphoadenopathy, increased eosinophilic count[Ref]
Metabolic
Postmarketing reports: Decreased weight[Ref]
Nervous system
Postmarketing reports: Loss of consciousness, headache, somnolence, dizziness[Ref]
Other
Common (1% to 10%): Ear pruritus
Postmarketing reports: Malaise, face edema, tinnitus, asthenia, influenza-like illness[Ref]
Psychiatric
Postmarketing reports: Anxiety[Ref]
