Label‑verified quick facts (United States, as of November 20, 2025)

FDA‑approved sublingual immunotherapy (SLIT) tablets for seasonal pollen allergies: Grastek (Timothy grass), Oralair (5‑grass), Ragwitek (short ragweed). No FDA‑approved tree‑pollen tablet exists in the U.S. (EU birch products are not FDA‑approved).
All SLIT tablets require: first dose in a medical setting with ≥30‑minute observation; prescription epinephrine auto‑injector plus training in its use.
Labeled start windows before season: Grastek ≥12 weeks; Oralair 4 months; Ragwitek ≥12 weeks. Continue through the season.
Labeled age ranges in 2025: Grastek 5–65; Oralair 5–65; Ragwitek 5–65. (Odactra—house dust mite, not pollen—also 5–65 after 2025 update.)

Tablet	Allergen (indication)	Labeled ages	When to start
Grastek	Timothy grass (and cross‑reactive grasses)	5–65	≥12 weeks before grass season, through season
Oralair	Five grasses (sweet vernal, orchard, perennial rye, Timothy, Kentucky blue)	5–65	4 months before grass season, through season
Ragwitek	Short ragweed	5–65	≥12 weeks before ragweed season, through season
–	Tree pollen (e.g., birch, oak)	–	No FDA‑approved U.S. tablet
Odactra	House dust mite (perennial; not pollen)	5–65	Daily year‑round; first dose supervised

Sources: FDA label pages and current Prescribing Information.

How to use this page

This page consolidates what the U.S. labels say for pollen SLIT tablets—who can take them, when to start, and the safety steps required. Use it to check timing each year and to verify the supervision/epinephrine rules that apply to every SLIT tablet.

Age eligibility (who can take what)

Grastek (Timothy grass): 5–65 years.
Oralair (5‑grass): 5–65 years.
Ragwitek (short ragweed): 5–65 years (pediatric expansion approved April 2021).
Odactra (house dust mite, not pollen): 5–65 years (label expanded to 5–11 years on Feb 28, 2025).

Note: Odactra is included for completeness about SLIT tablets but is not a pollen product.

The first‑dose rule and epinephrine training (applies to all SLIT tablets)

First dose must be given under supervision of a clinician experienced in allergic diseases, with at least 30 minutes of observation in a setting prepared to treat anaphylaxis.
Prescribe an epinephrine auto‑injector; instruct and train the patient/parent in its use; seek immediate medical care if epinephrine is used. Carry epinephrine for the duration of therapy.

When to start (label timing windows)

Grastek: start at least 12 weeks before the expected grass season. Continue through the season. Optionally, daily for three consecutive years for sustained effect.
Oralair: start about four months before grass season and continue through the season.
Ragwitek: start at least 12 weeks before ragweed season and continue through the season.
Odactra: daily year‑round (perennial HDM).

For help anticipating local pollen seasons, see Wyndly’s pollen data dashboard and our grass pollen allergy guide.

There is no FDA‑approved tree‑pollen SLIT tablet in the U.S.

As of November 20, 2025, the FDA lists only four SLIT tablets: Grastek (Timothy grass), Oralair (5‑grass), Ragwitek (ragweed), and Odactra (dust mite). No birch/oak/other tree‑pollen tablet is FDA‑approved in the U.S. (some exist in Europe).

Label safety notes seen across tablets (summarized)

Contraindications include severe, unstable, or uncontrolled asthma; prior severe systemic or severe local reaction to SLIT; eosinophilic esophagitis; hypersensitivity to excipients.
Common local reactions: oral/throat itching or swelling; ear itching; mouth edema; throat irritation. Counsel on recognition and when to contact care team.

How to start a pollen SLIT tablet safely (label‑aligned steps)

1) Confirm sensitization by skin test or specific IgE to the target pollen. 2) Schedule the in‑office first dose during the labeled pre‑season window (≥12 weeks for Grastek or Ragwitek; 4 months for Oralair). 3) Bring an epinephrine auto‑injector prescription plan; receive training before going home. 4) Daily home dosing: place tablet under the tongue; do not swallow for ≥1 minute; avoid food/drink for 5 minutes after; continue through season. 5) Reassess annually; continue per label and clinician guidance.

Frequently asked questions (label‑centric)

What if I miss the pre‑season window?
Labels study pre‑season initiation. In‑season initiation has not been established in U.S. labels; discuss risks/benefits and local pollen timing with your clinician.
Do tablets replace carrying epinephrine?
No. All tablet labels require prescribing an auto‑injector and training; continue to carry it while on therapy.
Are tablets approved for trees like birch or oak in the U.S.?
No. Only grass (Grastek, Oralair), ragweed (Ragwitek), and dust mite (Odactra) tablets are FDA‑approved.
Are children eligible?
Yes—labels now list ages 5–65 for Grastek, Oralair, and Ragwitek; Odactra also 5–65 after the 2025 pediatric expansion.
Where can I learn about long‑term, doctor‑guided SLIT for multiple allergens?
See Wyndly’s pollen immunotherapy overview and our state‑by‑state pollen resources.

Pollen SLIT Tablet Label Facts (ages 5–65, first‑dose supervision, epinephrine, timing)