Grastek Side Effects

Generic name: timothy grass pollen allergen extract

Medically reviewed by Drugs.com. Last updated on Dec 12, 2022.

Note: This document provides detailed information about Grastek Side Effects associated with timothy grass pollen allergen extract. Some dosage forms listed on this page may not apply specifically to the brand name Grastek.

Applies to timothy grass pollen allergen extract: sublingual tablet.

Important warnings This medicine can cause some serious health issues

Sublingual route (tablet)

Timothy Grass Pollen Allergen Extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.

Do not administer Timothy Grass Pollen Allergen Extract to patients with severe, unstable or uncontrolled asthma.

Observe patients in the office for at least 30 minutes following the initial dose.

Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

Timothy Grass Pollen Allergen Extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction, or in patients who may be unresponsive to epinephrine or inhaled bronchodilators (eg, those taking beta-blockers).

Serious side effects of Grastek

Along with its needed effects, timothy grass pollen allergen extract (the active ingredient contained in Grastek) 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 timothy grass pollen allergen extract:

More common

• itching of the ears, mouth, or tongue
• numbness or tingling feeling around the mouth
• sore throat
• swelling of the mouth

Less common

• chest discomfort
• difficult or labored breathing
• difficulty swallowing
• hives or welts, itching, or skin rash
• redness, swelling, or soreness of the tongue or in the mouth
• runny nose
• swelling of the lips
• tightness in the chest

Incidence not known

• cough
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating
• unusual tiredness or weakness

Other side effects of Grastek

Some side effects of timothy grass pollen allergen extract 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:

Less common

• acid or sour stomach
• dry throat
• headache
• heartburn
• nausea

Incidence not known

• diarrhea
• drowsiness

For healthcare professionals

Applies to timothy grass pollen allergen extract: sublingual tablet.

General

The most common side effects were ear pruritus, oral pruritus, tongue pruritus, mouth edema, and throat irritation.^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Systemic allergic reactions (including anaphylaxis)
• Postmarketing reports: Anaphylactic reaction, angioedema^[Ref]

Respiratory

• Very common (10% or more): Throat irritation (up to 22.6%)
• Common (1% to 10%): Pharyngeal edema, dry throat, oropharyngeal pain, nasal discomfort, throat tightness, dyspnea, pharyngeal erythema, cough, nasal congestion, sneezing
• Uncommon (0.1% to 1%): Rhinorrhea, dysphonia
• Postmarketing reports: Asthma exacerbation, hoarseness, laryngitis, induced asthma exercise, decreased forced expiratory volume, hyperventilation, laryngeal discomfort, decreased oxygen saturation, decreased peak expiratory flow rate, pneumonia, respiratory distress, status asthmaticus, decreased vital capacity, wheezing^[Ref]

Cardiovascular

• Common (1% to 10%): Chest discomfort
• Postmarketing reports: Chest pressure, increased heart rate, irregular heart rate, hypotension^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, urticaria
• Postmarketing reports: Facial erythema, rash^[Ref]

Gastrointestinal

• Very common (10% or more): Oral pruritus ( up to 26.7%), Lip pruritus (up to 11.1%), mouth edema ( up to 11.1%)
• Common (1% to 10%): Lip pruritus, oral paresthesia, tongue pruritus, lip swelling, swollen tongue, dyspepsia, oral hypoesthesia, nausea, oral discomfort, oral mucosal erythema, lip edema, glossitis, stomatitis, tongue disorder, tongue edema, glossodynia, dysphagia, palatal edema, glossodynia
• Uncommon (0.1% to 1%): Abdominal pain, gastroesophageal reflux, mouth swelling, oral/pharyngeal itching
• Postmarketing reports: Oral ulceration, ulcerative colitis exacerbation, diarrhea, eosinophilic esophagitis, oral pain, throat pruritus, vomiting^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Postmarketing reports: Altered state of consciousness, difficulty speaking, dizziness, drowsiness, tremor^[Ref]

Other

• Very common (10% or more): Ear pruritus (up to 12.5%)
• Common (1% to 10%): Fatigue
• Uncommon (0.1% to 1%): Ear itching
• Postmarketing reports: facial edema, sensation of foreign body, neck swelling^[Ref]

Further information

Grastek side effects can vary depending on the individual. 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.

Medical Disclaimer