Note: This document contains side effect information about timothy grass pollen allergen extract. Some dosage forms listed on this page may not apply to the brand name Grastek.

Summary

Common side effects of Grastek include: mouth edema, throat irritation, and pruritus of ear. Continue reading for a comprehensive list of adverse effects.

Applies to timothy grass pollen allergen extract: sublingual tablet.

Timothy grass pollen allergen extract may cause a severe allergic reaction. Stop taking the medicine and Get emergency medical help if you have any of these signs of an allergic reaction while taking timothy grass pollen allergen extract (the active ingredient contained in Grastek)

• severe dizziness or a light-headed feeling (like you might pass out);

• fast heart rate;

• stomach pain, vomiting, diarrhea;

• hives, itching, flushing (warmth, redness, or tingly feeling);

• cough, chest tightness, wheezing, trouble breathing; or

• swelling of your face, lips, tongue, or throat.

If you stop taking timothy grass pollen allergen extract after having an allergic reaction, do not start taking the medicine again without your doctor's advice.

Call your doctor at once if you have:

• severe mouth or throat irritation;

• breathing problems; or

• choking feeling, chest pain, trouble swallowing.

Common side effects may include:

• swelling or itching of your mouth or tongue;

• throat irritation; or

• itching in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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]