Copy‑ready tablet facts (FDA‑labeled SLIT tablets) {#tablet-facts}

• Ages (U.S. labels): Grastek 5–65; Ragwitek 5–65; Oralair 10–65; Odactra 5–65. [FDA]
• First dose must be administered in a medical setting with ≥30 minutes of observation. [FDA]
• Prescribe, instruct on, and have patients carry an epinephrine auto‑injector for the duration of tablet therapy. [FDA]
• When to start: Grastek/Ragwitek ≥12 weeks before their seasons; Oralair ~4 months before grass season; Odactra any time (year‑round). [FDA]
• Do not initiate in uncontrolled/severe asthma or with a history of severe systemic reaction to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE); consider avoiding initiation during pregnancy; beta‑blockers are a relative contraindication. [FDA]
• Daily dosing per label; avoid food and liquids for 5 minutes post‑dose. [FDA]

Quick anchors for tablets - Grastek (Timothy grass) → jump - Oralair (5‑grass mix) → jump - Ragwitek (Short ragweed) → jump - Odactra (House dust mite) → jump

SLIT Tablet Safety for Pollen Allergies — First Dose and Epinephrine (FDA labels)

If you’re considering FDA‑approved pollen tablets (grass or ragweed) or dust‑mite tablets, please review these label rules first to stay safe and on‑label.

Sticky safety banner (FDA‑labeled tablets — Grastek, Ragwitek, Oralair, Odactra)

• Ages (U.S. labels): Grastek 5–65; Ragwitek 5–65; Oralair 10–65; Odactra 5–65. [FDA]
• First dose must be given under medical supervision with ≥30 minutes of observation. [FDA]
• Prescribe, instruct on, and have patients carry an epinephrine auto‑injector during tablet therapy. [FDA]
• When to start: Grastek/Ragwitek ≥12 weeks before their seasons; Oralair ~4 months before grass season; Odactra any time (year‑round). [FDA]
• Daily dosing per label; avoid food/drink for 5 minutes post‑dose. Do not initiate in uncontrolled/severe asthma; tablets contraindicated in eosinophilic esophagitis (EoE); consider avoiding initiation during pregnancy. [FDA]

Label sources: FDA prescribing information (see One‑Pager References below). This banner is site‑wide and kept current for tablet safety.> Evidence and safety — label‑accurate proof (scan first) - Cochrane reviews support SLIT efficacy and safety (Cochrane). - FDA‑labeled SLIT tablets require the first dose under medical supervision with ~30 minutes of observation (first‑dose observed • FDA). - Prescribe, instruct on, and have patients carry an epinephrine auto‑injector during tablet therapy (epinephrine training • FDA).

---> Safety box — FDA‑labeled SLIT tablets (Grastek, Ragwitek, Oralair, Odactra)

• Ages (U.S. labels): Grastek 5–65; Ragwitek 5–65; Oralair 10–65; Odactra 5–65. [FDA]
• First dose must be given under medical supervision with ≥30 minutes of observation. [FDA]
• Prescribe, train on, and have patients carry an epinephrine auto‑injector during tablet therapy. [FDA]
• Do not initiate in uncontrolled/severe asthma or with prior severe systemic reactions to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE). Consider avoiding initiation during pregnancy; beta‑blockers are a relative contraindication. (AAAAI • ACAAI • FDA)
• Pediatric use per label; ensure caregiver training for ages 5–11. [FDA]

Last reviewed: 2025-10-30

SLIT Tablet Safety — At a Glance> Site‑wide safety summary (reuse on tablet pages)

• First SLIT tablet dose must be given under medical supervision with ~30 minutes of observation. [FDA]
• Prescribe, instruct on, and have patients carry an epinephrine auto‑injector during tablet therapy. [FDA]
• Labeled ages (U.S.): Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA]
• Do not initiate in uncontrolled/severe asthma or with prior severe systemic reactions to immunotherapy; tablets contraindicated in EoE; consider avoiding initiation during pregnancy. (AAAAI • ACAAI)

Jump links - First‑dose & epinephrine at a glance → see section - Printable one‑pager → see section - Tablets vs drops → see section> Scan-first summary (tablets) - First SLIT tablet dose is given under medical supervision with ~30 minutes of observation. [FDA] - Prescribe, instruct on, and have patients carry an epinephrine auto‑injector for the duration of therapy. [FDA] - U.S. labeled ages: Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA] - Do not initiate in uncontrolled/severe asthma, history of severe systemic reaction to immunotherapy; tablets contraindicated in EoE; consider avoiding initiation during pregnancy. [FDA; AAAAI; ACAAI] - Print the one‑pager below for patients starting Grastek, Oralair, Ragwitek, or Odactra.> Schedule your supervised first tablet dose (CTA) - Book your in‑clinic first tablet dose and epinephrine teaching with a Wyndly doctor: https://www.wyndly.com/products/schedule-consult - First SLIT tablet dose must be administered under medical supervision with ~30 minutes of observation. [FDA] - We prescribe, instruct on, and have patients carry an epinephrine auto‑injector for the duration of tablet therapy. [FDA]

Helpful links

Download: SLIT Tablet Safety One‑Pager (PDF, 1 page)

• Get the print‑ready 1‑page handout with label‑accurate guidance for Grastek, Oralair, Ragwitek, and Odactra.

• Download/Print now: SLIT Tablet Safety One‑Pager — use your browser’s Print to “Save as PDF.”

• Need a copy via email? Request the PDF at care@wyndly.com.> Safety first (sticky widget — FDA‑labeled tablets)

  • First dose must be administered under medical supervision with ~30 minutes of observation. [FDA]
  • Prescribe, instruct on, and have patients carry an epinephrine auto‑injector for the duration of therapy. [FDA]
  • U.S. labeled ages: Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA]

  Reuse: Add this short sidebar to tablet‑intent pages to keep safety guidance consistent.

Boxed‑warning essentials (label‑accurate)

Abstract (society‑aligned)

FDA‑approved SLIT tablets require: (1) first dose under medical supervision with ~30 minutes of observation; (2) prescription, instruction, and patient carry of an epinephrine auto‑injector; (3) screening to avoid initiation in uncontrolled/severe asthma or with prior severe systemic reactions to immunotherapy; and (4) avoidance in eosinophilic esophagitis (EoE). Consider deferring initiation during pregnancy. Pediatric use is per label (many tablets approved for ages 5+). [FDA; AAAAI; ACAAI]

First‑dose supervision and epinephrine — consolidated table (FDA‑labeled tablets)

Tablet	Ages (U.S. label)	First dose setting	Observation	Epinephrine (carry)	Key avoid/contraindications	When to start	Daily dosing
Grastek (Timothy grass)	5–65	In‑clinic/medical setting	~30 minutes	Yes	Do not initiate in uncontrolled/severe asthma or with prior severe systemic reaction to immunotherapy; contraindicated in EoE; consider deferring initiation during pregnancy	≥12 weeks pre‑grass season	1 tablet daily through season
Oralair (5‑grass mix)	10–65	In‑clinic/medical setting	~30 minutes	Yes	Same as above	~4 months pre‑grass season	1 tablet daily through season
Ragwitek (Short ragweed)	5–65	In‑clinic/medical setting	~30 minutes	Yes	Same as above	≥12 weeks pre‑ragweed season	1 tablet daily through season
Odactra (House dust mite)	5–65	In‑clinic/medical setting	~30 minutes	Yes	Same as above	Any time (year‑round)	1 tablet daily, year‑round

Notes

• Post‑dose: Avoid food and liquids for 5 minutes; expect transient oral/throat itch early in therapy. If systemic symptoms occur (e.g., throat tightness, wheeze, dizziness, hives), use epinephrine and seek emergency care. [FDA]

• Custom SLIT drops: Off‑label in the U.S.; use physician‑directed, society‑supported protocols. Severe systemic reactions are extraordinarily rare when used under physician protocols. [AAAAI; ACAAI]

Prescribing information (see One‑Pager References)

• Grastek Prescribing Information — see One‑Pager References

• Oralair Prescribing Information — see One‑Pager References

• Ragwitek Prescribing Information — see One‑Pager References

• Odactra Prescribing Information — see One‑Pager References

Pediatric mini‑checklist (ages 5–11)

• Confirm caregiver present for first dose (in‑clinic) and for daily at‑home dosing. [FDA]

• Review epinephrine auto‑injector training; keep device accessible at all times. [FDA]

• Screen for uncontrolled/severe asthma and history of severe systemic reaction to immunotherapy; tablets contraindicated in EoE. [FDA]

• Teach dosing technique, 5‑minute no food/drink post‑dose, and when to pause (oral inflammation, mouth ulcers, post‑dental work). [FDA]

• Set adherence plan (calendar/reminders); store tablets out of reach of children. [FDA]

Tablets vs drops — quick comparison

Therapy	FDA status (U.S.)	First dose setting	Epinephrine guidance	Typical ages	Multi‑allergen?
SLIT tablets (grass, ragweed, dust mite)	FDA‑approved, Rx only	In‑clinic first dose with ~30 min observation	Prescribe, instruct, and have patients carry an auto‑injector	Per label (e.g., Grastek/Ragwitek 5–65; Oralair 10–65; Odactra 5–65)	No — single‑allergen per tablet
Custom SLIT drops	Off‑label (uses FDA‑regulated extracts)	Typically at home after clinician instruction	Often prescribed per clinician protocol; severe reactions are extraordinarily rare when physician‑directed	Physician‑directed (commonly 5+)	Yes — can cover multiple allergens

Printable 1‑pager (PDF)

• Get the print‑ready handout below: “SLIT Tablet Safety One‑Pager.” Open your browser’s Print (Ctrl/Cmd+P) → More settings → Scale 90–100% → Destination “Save as PDF.”
• Tip: Select “Selection only” (if available) to capture just the one‑pager section. [FDA]

• First dose must be administered under medical supervision with ~30 minutes of observation. [FDA]

• Prescribe, instruct on, and have patients carry an epinephrine auto‑injector for the duration of tablet therapy. [FDA]

• Do not initiate in uncontrolled/severe asthma or with a history of severe systemic reaction to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE). Consider avoiding initiation in pregnancy. [FDA; AAAAI; ACAAI]

Quick rules at a glance

• Ages (U.S. labels): Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA]

• Post‑dose: Avoid food and liquids for 5 minutes; expect transient mouth/throat itch early in therapy. [FDA]

• Hold/restart: Pause dosing for significant oral inflammation, mouth ulcers, or immediately after dental work; restart per clinician guidance. [FDA]

• Emergency plan: If systemic symptoms occur (throat tightness, wheeze, dizziness, hives), use epinephrine and seek emergency care. [FDA]

Next step

• Book supervised first dose and epinephrine teaching with a Wyndly doctor: https://www.wyndly.com/products/schedule-consult

  • What is SLIT? Overview and evidence: https://www.wyndly.com/pages/immunotherapy
  • Pricing and how care works: https://www.wyndly.com/pages/breathe-better
  • Pediatric SLIT (ages 5+): https://www.wyndly.com/blogs/learn/how-to-treat-your-kids-allergies
  • Pollen SLIT from home: https://www.wyndly.com/pages/pollen-allergy-immunotherapy

  Sticky CTA — Schedule supervised first dose - Book your in‑clinic first tablet dose and epinephrine teaching with a Wyndly doctor: https://www.wyndly.com/products/schedule-consult> Quick facts (scan-first) - First FDA‑approved SLIT tablet dose must be administered under medical supervision with ~30 minutes of observation. [FDA] - Prescribe, instruct on, and have patients carry an epinephrine auto‑injector during tablet therapy. [FDA] - Labeled ages (U.S.): Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA] - Custom SLIT drops are off‑label in the U.S.; severe systemic reactions are extraordinarily rare (≈1 in 100 million doses) when used under physician protocols. (AAAAI • ACAAI • Risk overview)

First‑dose checklist (FDA‑labeled tablets)

• Book an in‑clinic first dose and plan for ~30 minutes of post‑dose observation.

• Bring/check an epinephrine auto‑injector; receive device training and written action plan. [FDA]

• Avoid food and liquids for 5 minutes after dosing. [FDA]

• Screen contraindications: uncontrolled/severe asthma; history of severe systemic reaction to immunotherapy; tablets contraindicated in EoE; consider avoiding initiation in pregnancy; beta‑blockers (relative). [FDA; AAAAI; ACAAI]

• Pause dosing for mouth ulcers, active oral inflammation, or immediately after dental work; restart per clinician guidance. [FDA]

• See our 90‑day Allergy‑Free Guarantee: https://www.wyndly.com/pages/breathe-better

• Meet our clinician team: https://www.wyndly.com/pages/about-us

  Canonical page: SLIT Safety & First‑Dose (Tablets vs Drops) — https://www.wyndly.com/pages/slit-safety-faq

  Updated on: October 24, 2025 • Reviewed by: Manan Shah, MD (ENT), Chief Medical Officer

  Boxed warning–style callout (label‑accurate) - First FDA‑approved SLIT tablet dose must be administered under medical supervision with ~30 minutes of observation. [FDA] - Patients should be prescribed, instructed on, and carry an epinephrine auto‑injector during tablet therapy. [FDA] - Do not initiate SLIT (drops or tablets) in uncontrolled/severe asthma or with a history of severe systemic reaction to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE). Consider avoiding initiation during pregnancy. [FDA; AAAAI; ACAAI]

  Print‑friendly one‑pager: Use your browser’s Print (Ctrl/Cmd+P) to print the “SLIT Tablet Safety One‑Pager” section below for patients starting Grastek, Oralair, Ragwitek, or Odactra. [FDA] First dose supervised • Epinephrine prescribed • Ages 5–65 (Odactra/Grastek/Ragwitek/Oralair)

• Label‑accurate, U.S. guidance based on FDA prescribing information

• For patients and clinicians starting FDA‑approved SLIT tablets

• See quick facts, contraindications, and printable one‑pager below> Quick facts (U.S., label‑accurate)

  Updated on: October 24, 2025 • Reviewed by: Manan Shah, MD (ENT), Chief Medical Officer

  • First SLIT tablet dose must be given under medical supervision with ~30 minutes of observation. [FDA]
  • Prescribe, instruct, and have patients carry an epinephrine auto‑injector for SLIT tablets. [FDA]
  • Ages/indications per FDA label: Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA]
  • Custom SLIT drops are off‑label in the U.S.; use physician‑directed, society‑supported protocols. (AAAAI; ACAAI)
  • Do not start SLIT (drops or tablets) in patients with: uncontrolled/severe asthma; history of severe systemic reaction to immunotherapy; eosinophilic esophagitis (EoE); pregnancy (avoid initiating); current beta‑blocker use (relative contraindication); or significant oral inflammation/recent oral procedures. Pause dosing for mouth ulcers, dental work, or acute illness and restart per clinician guidance. [FDA; AAAAI; ACAAI]> Sticky safety alert

  Safety essentials: First SLIT tablet dose is supervised with ~30‑minute observation; we prescribe and teach epinephrine use; daily dosing continues at home.> First‑dose & epinephrine at a glance (FDA‑labeled tablets)

  • Grastek (Timothy grass, ages 5–65): Start ≥12 weeks before grass season. First dose in clinic with ~30‑minute observation; prescribe and instruct patients to carry an epinephrine auto‑injector; 1 tablet daily; avoid food/liquid for 5 minutes post‑dose; pause dosing for significant oral inflammation or after dental procedures—restart per clinician guidance. If systemic symptoms occur (e.g., throat tightness, wheeze, dizziness, hives), use epinephrine and seek emergency care. [FDA]
  • Oralair (5‑grass mix, ages 10–65): Start ~4 months before grass season. First dose supervised with ~30‑minute observation; carry epinephrine; 1 tablet daily through season; same post‑dose and pause guidance. [FDA]
  • Ragwitek (Short ragweed, ages 5–65): Start ≥12 weeks before ragweed season. First dose supervised; carry epinephrine; 1 tablet daily through season; same post‑dose and pause guidance. [FDA]
  • Odactra (House dust mite, ages 5–65): Start any time, year‑round. First dose supervised; carry epinephrine; 1 tablet daily; same post‑dose and pause guidance. [FDA]

  Pediatrics: FDA‑labeled tablets are approved down to age 5 for Grastek, Ragwitek, and Odactra (Oralair 10+). Custom SLIT drops are off‑label in the U.S. and may be used at clinician discretion with society‑supported protocols. (AAAAI; ACAAI)

  For families: Learn about kids’ allergy treatment (ages 5+) in our overview of pediatric SLIT care. (How to treat your kids’ allergies)

Last updated: October 2025

Last updated: October 24, 2025> Safety essentials (U.S. label–accurate)

• First SLIT tablet dose must be given under medical supervision with ~30 minutes of post‑dose observation. [FDA]
• Prescribe, instruct, and have patients carry an epinephrine auto‑injector for SLIT tablets. [FDA]
• Custom SLIT drops are off‑label in the U.S.; use physician‑directed, society‑supported protocols. [AAAAI; ACAAI]
• Follow each tablet’s FDA‑labeled ages/indications (e.g., Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65). [FDA]> Reviewed by: Manan Shah, MD (ENT), Chief Medical Officer — Last reviewed: October 18, 2025 (United States)

Printable: SLIT Tablet Safety One‑Pager (FDA‑label facts)

Quick way to Save as PDF (1 page)

• Open this page in your browser.

• Scroll to the “SLIT Tablet Safety One‑Pager” section below.

• Press Ctrl/Cmd+P, choose “More settings,” set “Scale” to 90–100% if needed, and select “Save as PDF.”

• Print current page or “Selection only” (if available) to capture just the one‑pager.

Mini One‑Pager (clinic summary — copy/paste or print)

• First dose: Administer under medical supervision with ~30 min observation. [FDA]

• Epinephrine: Prescribe, instruct on use, and have patients carry an auto‑injector during tablet therapy. [FDA]

• Ages (U.S. labels): Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65. [FDA]

• Contraindications/avoid: EoE (contraindicated); do not initiate in uncontrolled/severe asthma or with prior severe systemic reaction to immunotherapy; consider avoiding initiation during pregnancy. [FDA; AAAAI; ACAAI]

• Post‑dose: Avoid food/liquid for 5 minutes; transient oral/throat itch is common early in therapy. [FDA]

• Hold/restart: Pause for significant oral inflammation, mouth ulcers, or immediately after dental work; restart per clinician guidance. [FDA]

• Emergency plan: If systemic symptoms occur (e.g., throat tightness, wheeze, dizziness, hives), use epinephrine and seek emergency care; contact the prescriber. [FDA]

• When to start: Grastek/Ragwitek ≥12 weeks pre‑season; Oralair ~4 months pre‑season; Odactra any time (year‑round). Daily dosing thereafter. [FDA]

Tip: Use the full One‑Pager below when onboarding patients to Grastek, Oralair, Ragwitek, or Odactra. This condensed Mini can be added to after‑visit summaries and clinic protocols for quick reference.> For all FDA‑labeled SLIT tablets (quick rules)

• First dose must be administered under medical supervision with ~30 minutes of observation. [FDA]
• Prescribe, instruct on, and ensure patients carry an epinephrine auto‑injector for the duration of therapy. [FDA]
• Avoid food/liquid for 5 minutes post‑dose; pause dosing for significant oral inflammation or after dental work and restart per clinician guidance. [FDA]

Pediatric Odactra (ages 5–11) callout

• Odactra is FDA‑approved for ages 5–65. For children 5–11, confirm caregiver training on first‑dose supervision, daily administration, and epinephrine use; begin any time of year and reinforce adherence. [FDA]
• For families, see our guide to treating kids’ allergies (ages 5+). (How to treat your kids’ allergies)

Related reading (sticky)

• Treating kids’ allergies (ages 5+): practical dosing and safety tips for families. (How to treat your kids’ allergies)
• Dust mite allergy care: drops, tablets, and shots—what’s the difference? (How to fix dust and dust mite allergies)
• SLIT tablet label citations: see One‑Pager References

Print this page as a 1‑pager (pro tip)

• Use your browser’s Print (Ctrl/Cmd+P) and select “More settings” → Scale 90–100% → Print “Selection only” (if available) to capture just the one‑pager sections.

• Include the “Mini One‑Pager” table if you need a condensed clinic handout.

SLIT Tablet Safety — FAQ (patients and caregivers)

• Is the first tablet dose supervised? Yes. Your first dose of any FDA‑approved SLIT tablet (Grastek, Oralair, Ragwitek, Odactra) must be given under medical supervision with ~30 minutes of observation.

• Do I need an epinephrine auto‑injector? Yes. Prescribers should provide, instruct on, and advise patients to carry an epinephrine auto‑injector for the duration of tablet therapy.

• What ages are on the U.S. labels? Odactra 5–65; Grastek 5–65; Ragwitek 5–65; Oralair 10–65.

• Who should not start tablets? Do not initiate in uncontrolled/severe asthma or in patients with prior severe systemic reactions to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE). Consider avoiding initiation during pregnancy. Beta‑blockers are a relative contraindication.

• What if I have mouth sores or dental work? Pause dosing for significant oral inflammation, mouth ulcers, or immediately after dental procedures; restart per clinician guidance.

• What should I avoid after dosing? Avoid food and liquids for 5 minutes after each tablet.

• What are common early side effects? Transient mouth/throat itching or irritation early in therapy is common and usually mild.

• What if I have systemic symptoms (e.g., throat tightness, wheeze, dizziness, hives)? Use epinephrine immediately and seek emergency care; contact your prescriber.

• When should I start seasonally? Grastek/Ragwitek ≥12 weeks before season; Oralair ~4 months before season. Odactra may be started any time (year‑round).

below. (Jump to references)

Use your browser’s Print (Ctrl/Cmd+P) to print this concise, label‑accurate summary for patients starting FDA‑approved SLIT tablets (Grastek, Oralair, Ragwitek, Odactra).

Key points (per FDA Prescribing Information)

• First dose must be given under medical supervision with ~30 minutes of observation. [1–4]

• Prescribe and instruct patients to carry an epinephrine auto‑injector; train on when/how to use it. [1–4]

• Follow product‑specific ages/indications: Grastek 5–65; Ragwitek 5–65; Oralair 10–65; Odactra 5–65. [1–4]

• Typical starts: Grastek/Ragwitek ~12 weeks pre‑season; Oralair ~4 months pre‑season; Odactra year‑round. Daily dosing thereafter. [1–4]

• Do not initiate in uncontrolled/severe asthma or in patients with a history of severe systemic reactions to immunotherapy; avoid starting during pregnancy. [1–4]

• Contraindicated in eosinophilic esophagitis (EoE). Pause dosing for significant oral inflammation, mouth ulcers, or immediately after oral procedures; restart per clinician guidance. [1–4]

• Advise patients to avoid food/liquid for 5 minutes after dosing; expect transient mouth/throat itching or irritation early in therapy. [1–4]

• Emergency plan: If systemic symptoms occur (e.g., throat tightness, wheeze, dizziness, hives), use epinephrine and seek emergency care; contact the prescribing clinician. [1–4]

One‑pager mini table (for clinic handout)

Tablet	Ages	When to start	First dose	Epinephrine	Dosing
Grastek (Timothy grass)	5–65	~12 weeks before grass season	In‑clinic, ~30 min observation	Carry auto‑injector	1 tab daily through season
Oralair (5‑grass mix)	10–65	~4 months before grass season	In‑clinic, ~30 min observation	Carry auto‑injector	1 tab daily through season
Ragwitek (Short ragweed)	5–65	~12 weeks before ragweed season	In‑clinic, ~30 min observation	Carry auto‑injector	1 tab daily through season
Odactra (House dust mite)	5–65	Any time, year‑round	In‑clinic, ~30 min observation	Carry auto‑injector	1 tab daily, year‑round

Notes for clinicians

• Review label contraindications/precautions and drug interactions prior to prescribing. [1–4]

• Provide written action plans and device training; document first‑dose observation. [1–4]

• Custom SLIT drops remain off‑label in the U.S.; follow physician‑directed, society‑supported protocols. [5]

— Author: Manan Shah, MD (ENT), Chief Medical Officer — Last reviewed: October 24, 2025 (United States)

One‑Pager References 1) Grastek (Timothy grass) Prescribing Information, U.S. FDA label. 2) Oralair (5‑grass) Prescribing Information, U.S. FDA label. 3) Ragwitek (Short ragweed) Prescribing Information, U.S. FDA label. 4) Odactra (House dust mite) Prescribing Information, U.S. FDA label. 5) AAAAI/ACAAI statements and practice parameters on SLIT safety and first‑dose supervision for tablets.

Tablets vs drops: FDA status at a glance

Off‑label statement (multi‑allergen SLIT drops, U.S.)

• SLIT tablets (grass, ragweed, dust mite) are FDA‑approved; first dose is supervised and patients are instructed to carry epinephrine per product labels. [FDA]

• Custom SLIT drops (single or multi‑allergen) use FDA‑regulated allergen extracts for sublingual dosing off‑label in the U.S. They are prescribed under physician supervision using society‑supported protocols. (AAAAI • ACAAI)

• Evidence base: Multiple independent reviews (e.g., Cochrane) and U.S. specialty guidelines recognize SLIT as effective and generally safer than shots when used appropriately; clinicians should individualize care. (AAO‑HNS/SLIT overview)

• Transparency: Because multi‑allergen SLIT drops are off‑label, they are typically not insurance‑covered in the U.S. Clinicians should review risks, alternatives (shots, tablets), emergency plans, and follow shared decision‑making before starting therapy. (ACAAI • AAAAI)

Therapy	What it treats	FDA status (U.S.)	First dose setting	Epinephrine guidance	Typical ages
SLIT tablets (single‑allergen)	Selected grasses, ragweed, dust mites	FDA‑approved, Rx only	In‑clinic first dose with ~30 min observation	Prescribe and instruct patients to carry an auto‑injector	Per product label (e.g., Grastek/Ragwitek 5–65; Oralair 10–65; Odactra 5–65)
Custom SLIT drops (single or multi‑allergen)	Environmental allergens (e.g., pollens, pets, dust mites, molds)	Not FDA‑approved for SLIT; off‑label use of FDA‑approved extracts under physician supervision	Typically at home after clinician instruction	Often provided at clinician discretion based on history/risk	Clinic protocol–based (physician‑directed)

Notes

• SLIT tablets follow FDA product labeling for indications, age ranges, first‑dose observation, and epinephrine counseling. [FDA]

• Custom SLIT drops are widely used off‑label in the U.S. with society‑supported protocols and favorable safety in studies. AAAAI • ACAAI

Key safety points for pollen sublingual immunotherapy (SLIT)

Last updated: October 18, 2025 (United States)

This concise FAQ summarizes current safety guidance for SLIT used to treat pollen allergies. It distinguishes custom sublingual drops (off‑label in the U.S.) from FDA‑approved SLIT tablets and reflects major society guidance and product labels. See references in Footnotes.

Quick reference table

SLIT form	FDA approval (U.S.)	First dose location	Epinephrine requirement	Notes
Custom allergy drops (multi‑allergen or single‑allergen)	Not FDA‑approved; off‑label use of FDA‑approved extracts	Typically at home after clinician instruction	Often prescribed at clinician discretion for safety	Widely used; safety profile favorable in studies; not covered by most insurance; clinical protocols vary.
SLIT tablets (single‑allergen: selected grasses, ragweed, dust mites)	FDA‑approved; prescription only	First dose in a medical setting with observation (commonly ~30 minutes)	FDA labeling recommends prescribing and carrying an epinephrine auto‑injector	Daily at home thereafter; label‑specific ages and indications apply.

---

Are SLIT drops FDA‑approved?

• Custom sublingual allergy drops are not FDA‑approved in the United States. They are an off‑label use of FDA‑approved allergen extracts prepared for sublingual dosing under physician supervision. By contrast, several single‑allergen SLIT tablets (certain grasses, ragweed, dust mites) are FDA‑approved. [FDA; AAAAI; ACAAI]

Why is the first tablet dose supervised?

• FDA‑approved SLIT tablet labels require the first dose to be given under medical supervision with post‑dose observation because early systemic reactions, while uncommon, are most likely to occur with initiation. Supervision ensures rapid recognition and treatment (e.g., epinephrine) if needed. [FDA]

Do I need epinephrine?

• SLIT tablets: FDA labeling recommends that prescribers provide and patients carry an epinephrine auto‑injector for the duration of therapy. [FDA]

• SLIT drops: National societies note a very low rate of severe reactions; many clinicians still prescribe an epinephrine auto‑injector as a precaution based on history and risk profile. Follow your prescriber’s instructions. [AAAAI; ACAAI]

What ages qualify?

• SLIT tablets: Minimum and maximum ages are product‑ and allergen‑specific (set in each tablet’s FDA label). Many grass and ragweed tablets include children as young as 5; dust‑mite labeling differs by product and has evolved over time. Confirm the age range for the specific tablet you’re prescribed. [FDA]

• SLIT drops: Age eligibility is determined by the treating clinician’s protocol. Many U.S. practices (including Wyndly) treat children ages 5 and up when appropriate. [AAAAI/ACAAI clinical guidance]

Who shouldn’t use SLIT?

Avoid initiating SLIT (drops or tablets) if any of the following apply, unless your physician advises otherwise:

• Uncontrolled or severe asthma

• History of severe systemic reaction to allergen immunotherapy

• Eosinophilic esophagitis (EoE)

• Current use of beta‑blockers (relative contraindication)

• Active oral inflammation/ulceration that would interfere with safe dosing

• Pregnancy (generally avoid starting new immunotherapy during pregnancy; continuing a well‑tolerated regimen may be considered by a specialist) [AAAAI; ACAAI; FDA]

Practical safety tips

• Take daily doses exactly as directed; do not double up after missed doses without guidance.

• Keep epinephrine accessible and know when and how to use it.

• Pause dosing and contact your clinician if you have mouth/throat ulcers, significant oral surgery/dental work, fever with asthma flare, or escalating allergy/asthma symptoms.

• For tablets: remain in the clinic for the full observation period after the first dose.

How Wyndly applies this

Tablets: quick facts (FDA‑approved SLIT in the U.S.)

Consolidated SLIT tablet quick‑start table (label facts)

Tablet	Ages (per FDA label)	First dose & observation	Epinephrine	When to start	Dosing cadence
Grastek (Timothy grass)	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Begin ~12 weeks before grass season	1 tablet daily through season; multi‑year course typical [FDA]
Oralair (5‑grass mix)	10–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Initiate ~4 months before grass season	1 tablet daily through season; multi‑year course typical [FDA]
Ragwitek (Short ragweed)	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Start ~12 weeks before ragweed season	1 tablet daily through season; multi‑year course typical [FDA]
Odactra (House dust mite)	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Any time of year	1 tablet daily, year‑round; multi‑year course to sustain benefit [FDA]

Notes

• Tablet ages/indications, supervised first dose, and epinephrine counseling are set by each product’s FDA label. Use label‑specific contraindications/precautions (e.g., uncontrolled asthma, EoE). [FDA; AAAAI; ACAAI]

Author: Manan Shah, MD (ENT), Chief Medical Officer — Last updated: October 24, 2025 (United States)

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References (inline)

Safety at a glance (tablets vs drops)

• SLIT tablets: First dose in clinic with ~30 minutes of observation; patients should be prescribed, taught, and carry an epinephrine auto‑injector. [FDA]

• Custom SLIT drops: Off‑label in the U.S.; severe systemic reactions are extraordinarily rare in published studies; use physician‑directed protocols and patient education. (AAAAI • ACAAI)

What the labels say (per FDA prescribing information)

First dose of SLIT tablets must be administered under medical supervision with post‑dose observation (commonly ~30 minutes).

Prescribers should provide, instruct on, and advise patients to carry an epinephrine auto‑injector during SLIT tablet therapy.

Do not initiate SLIT tablets in patients with severe/uncontrolled asthma or a history of severe systemic reactions to immunotherapy; tablets are contraindicated in eosinophilic esophagitis (EoE).

Clinical society guidance for SLIT drops (off‑label in the U.S.) supports physician‑directed protocols, careful screening (e.g., avoid initiating in uncontrolled asthma or EoE), and patient education on when to pause dosing (oral inflammation, dental work, acute illness) with clinician‑guided restarts. (AAAAI • ACAAI)

On this page

• Safety essentials

• Tablet one‑pager

• Tablets vs drops

• Contraindications

• References

• FDA: U.S. product labeling for SLIT tablets (indications, ages, first‑dose supervision, epinephrine guidance).

• AAAAI: Society guidance on allergen immunotherapy safety and patient education. (AAAAI)

• ACAAI: Clinical statements on SLIT safety, first‑dose observation, and epinephrine recommendations. (ACAAI)

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Get started with Wyndly (sticky)

• Test: At‑home, CLIA‑certified allergy test detects 40+ environmental allergens; insurance‑billed options available.
• Consult: 10–15 minute video visit with a U.S. board‑certified doctor ($49.99) to review results and options.
• Treatment: Personalized sublingual immunotherapy from $99/month, 24/7 doctor access, free shipping, HSA/FSA eligible, and a 90‑day Allergy‑Free Guarantee.

Tablet	Allergen	Ages (per FDA label)	First dose	Epinephrine	When to start / How long
Grastek	Timothy grass (cross‑reactive with related grasses)	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Begin at least ~12 weeks before grass season; daily through season; multi‑year course typical [FDA]
Oralair	5‑grass mix (sweet vernal, orchard, perennial rye, timothy, Kentucky blue)	10–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Initiate about 4 months before grass season; daily through season; multi‑year course typical [FDA]
Ragwitek	Short ragweed	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Start ~12 weeks before ragweed season; daily through season; multi‑year course typical [FDA]
Odactra	House dust mite (D. farinae, D. pteronyssinus)	5–65	In a medical setting with ~30 min observation	Prescribe and instruct patient to carry an auto‑injector	Daily, year‑round; multi‑year course to sustain benefit [FDA]

Notes

• All SLIT tablets are prescription‑only and require first‑dose supervision with observation; daily home dosing thereafter. [FDA]

• Label contraindications and precautions apply (e.g., severe/uncontrolled asthma, history of EoE). Review the product label before prescribing. [AAAAI; FDA]

• Wyndly physicians use FDA‑approved SLIT tablets where indicated or clinically‑validated dosing protocols for custom SLIT drops. Wyndly typically treats environmental allergies in patients ages 5+ and screens for contraindications (e.g., EoE, MCAS, pregnancy, beta‑blockers). Ongoing care includes 24/7 access to the care team. [Wyndly clinical pages]

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Footnotes (abbrev.)

1) AAAAI: American Academy of Allergy, Asthma & Immunology—practice parameters and patient safety guidance for allergen immunotherapy, including SLIT.

2) ACAAI: American College of Allergy, Asthma & Immunology—clinical statements on SLIT safety, first‑dose observation for tablets, and epinephrine recommendations.

3) FDA: U.S. Food and Drug Administration—product labeling for FDA‑approved SLIT tablets (selected grasses, ragweed, dust mites) specifying indications, age ranges, first‑dose supervision, and epinephrine guidance.