"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
Ragwitek Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ragwitek (short ragweed pollen allergen extract) contains a pollen allergen extract from short ragweed (Ambrosia artemisiifolia) and is used as immunotherapy to treat short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Common side effects of Ragwitek include:
- throat irritation
- itching of the mouth or ears
- mouth swelling
- tongue itching
- swelling under the tongue
- lip itching or swelling, and
- a sensation of burning, numbness, tingling, itching, or prickling of the mouth
- difficulty breathing, tightness in the throat, difficulty swallowing, dizziness, fainting, rapid or weak heartbeat, severe stomach cramps or vomiting, diarrhea, or severe flushing or itching of the skin.
The dose is one Ragwitek tablet daily. Ragwitek may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ragwitek should only be used if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ragwitek (short ragweed pollen allergen extract) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ragwitek FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 4 placebo-controlled clinical trials, 1057 subjects 18 years of age and older with short ragweed pollen-induced rhinitis, with or without conjunctivitis, received at least one dose of RAGWITEK, of whom 642 (61%) completed at least 12 weeks of therapy. Of the subjects treated with RAGWITEK, 52% were male, 25% had mild asthma, and 82% were sensitized to other allergens in addition to ragweed pollen. The subject population was 83% White, 12% African American, and 2% Asian. Subject demographics in placebo treated subjects were similar to the active group. The pooled analysis includes safety data from two 28-day safety studies and safety data from the first 28 days of two 52-week safety and efficacy studies. Adverse reactions reported in ≥1% of subjects in the 28-day pooled analysis treated with RAGWITEK are shown in Table 1.
The most common adverse reactions reported in subjects treated with RAGWITEK were throat irritation (16.6% vs 3.3% placebo), oral pruritus (10.9% vs 2.0%), ear pruritus (10.4% vs 1.1%), and oral paraesthesia (10.0% vs 4.0%). The percentage of subjects who discontinued from the clinical trials because of an adverse reaction while exposed to RAGWITEK or placebo was 4.4% and 0.8%, respectively. The most common adverse reactions that led to study discontinuation in subjects who were exposed to RAGWITEK were mouth edema, swollen tongue, and dysphagia.
One subject (1/1057; 0.1%) who received RAGWITEK experienced a treatment-related severe systemic allergic reaction that led to discontinuation of RAGWITEK. The subject had local reactions starting on Day 1 of treatment with RAGWITEK. On Day 6 symptoms progressed and included swelling of the throat, dyspnea, nausea, and lightheadedness. The subject fully recovered after treatment with epinephrine (self-administered), antihistamines, and oral corticosteroids.
Table 1: Adverse Reactions Reported in ≥1% of
Subjects Treated with RAGWITEK (28-day pooled analysis)
|Ear and Labyrinth Disorders|
|Respiratory, Thoracic and Mediastinal Disorders|
|Skin and Subcutaneous Tissue Disorders|
|General Disorders and Administration Site Conditions|
The overall safety profile beyond Day 28 in the two 52-week trials was similar to that observed in the pooled 28-day analysis.
Read the entire FDA prescribing information for Ragwitek (Short Ragweed Pollen Allergen Extract Tablets)
Additional Ragwitek Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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