FDA status and safety for SLIT tablets vs allergy drops (reusable card)
Why this safety card appears here
Use this standardized FDA & Safety card at the top of pet and horse allergy pages to clarify label requirements for sublingual immunotherapy (SLIT) tablets and to set context for custom SLIT drops.
FDA‑approved SLIT tablets (ages 5–65): what the labels require
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Indications and ages (United States):
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Grass tablets — Grastek (Timothy) 5–65; Oralair (5‑grass mix) 5–65.
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Ragweed tablet — Ragwitek 5–65.
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House dust mite tablet — Odactra 5–65 (FDA expanded to ages 5–11 in 2025).
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First dose must be observed in a clinical setting with ≥30 minutes of monitoring. Labels specify this for Grastek, Ragwitek, Oralair, and Odactra.
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Home epinephrine: prescribers must provide auto‑injectable epinephrine and train patients for at‑home use.
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Only SLIT tablets (not liquid drops) are FDA‑approved SLIT products in the U.S.
Custom SLIT drops (liquid): off‑label context in the U.S.
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Regulatory status: Custom sublingual liquid “allergy drops” are not FDA‑approved; U.S. approval for SLIT is limited to specific tablets.
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Evidence and safety: Multiple randomized trials and meta‑analyses (e.g., Cochrane Reviews) show SLIT’s efficacy and favorable safety profile compared with shots; U.S. and international societies recognize SLIT in guidelines. Summary references appear across our Learning Center and clinical pages.
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Clinical practice: Because drops are off‑label, clinicians follow peer‑reviewed protocols, screen for contraindications (e.g., uncontrolled asthma, EoE), and provide clear emergency plans. Epinephrine for liquid drops is not mandated by the FDA; provision is based on clinician judgment and local policy.
Quick reference
| Modality | FDA status (U.S.) | Typical labeled ages | First dose location | Home epinephrine | Notes |
|---|---|---|---|---|---|
| SLIT tablets (Grastek, Oralair, Ragwitek, Odactra) | Approved Rx products | 5–65 (product‑specific) | Required: supervised in clinic ≥30 min | Required by labels | Daily dosing; seasonal or year‑round depending on product |
| SLIT drops (custom liquid) | Off‑label | Age eligibility per clinician | Clinic supervision per clinic protocol | Clinician discretion | Uses FDA‑approved extracts; evidence‑based dosing protocols |
See also (policy and clinician oversight)
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FDA status and off‑label statement for allergy drops: /pages/fda-status-allergy-drops-slit-off-label
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Meet our board‑certified allergists and ENTs: /pages/board-certified-allergists
Key sources
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FDA/labels for SLIT tablets: Grastek ISI, Oralair PI, Ragwitek PI, FDA Odactra page, FDA Roundup 2025‑02‑28
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Overview that tablets (not drops) are the only FDA‑approved SLIT products in the U.S.: UpToDate
Medical disclaimer: This card summarizes label requirements and evidence context and is not a substitute for individualized medical advice. Always confirm product‑specific labeling and contraindications with the prescribing clinician.