FDA-filed SPL labeling · retrieved through openFDA

Dermatophagoides Pteronyssinus / House Dust Mite

House dust mite extract (Dermatophagoides pteronyssinus) is an allergenic extract used for skin testing to diagnose mite allergy and for immunotherapy (allergy shots) to reduce symptoms in people with a confirmed mite allergy.

Drug class Standardized Insect Allergenic Extract
Rx Form 1 Routes Cutaneous; Intradermal; Subcutaneous · Cutaneous, Intradermal, Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 3, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 3, 2025
AvailabilityRx
Earliest approval/marketing year 1986
FDA-listed product records 2
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 18, 2026
Dermatophagoides Pteronyssinus / House Dust Mite at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
House dust mite extract is used both to diagnose mite allergy through skin testing and to treat it through a carefully dosed series of allergy shots. Because it can cause severe and potentially life-threatening reactions, it must always be administered in a medical setting by a trained specialist. Follow your doctor's dosing schedule exactly, never skip the post-injection observation period, and report any reaction before your next appointment.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

This product can cause severe allergic reactions and death — especially in people with steroid-dependent or unstable asthma. It must only be administered by or under the close supervision of a physician experienced in allergy and allergenic extracts. Your first dose must be based on skin testing results. You must be watched for at least 20 minutes after every injection, and emergency equipment must be on hand. If you are switching from a different type or lot of extract, your dose will be restarted at a much lower level. If you take beta-blocking drugs, tell your doctor — these can interfere with the emergency treatment (epinephrine) used if you have a serious reaction. This product must never be injected into a vein.

Read the full warning on DailyMed →

📖 Dermatophagoides Pteronyssinus / House Dust Mite: Patient Information Guide

A plain-language walkthrough of Dermatophagoides Pteronyssinus / House Dust Mite — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

House dust mite extract is an allergenic extract with two main uses: confirming a mite allergy through skin testing, and reducing allergy symptoms through immunotherapy (allergy shots).

  • Allergy diagnosis: Used via scratch, prick-puncture, or intradermal skin testing to identify sensitivity to house dust mites in patients with a history of mite or house dust allergy
  • Allergy immunotherapy (treatment): Used by subcutaneous injection in patients whose mite allergy has been confirmed by skin testing, to help reduce symptoms associated with house dust allergy
  • Both uses require physician supervision by someone with specialized allergy training
⚙️How it works

For skin testing, the extract works by triggering a local immune response: the mite allergen binds to IgE antibodies (allergy-specific proteins) on the surface of mast cells (immune cells in the skin), causing them to release histamine and other chemicals. This produces the familiar small raised bump (wheal) and redness (erythema) that signals an allergy is present.

For immunotherapy, the exact mechanism is not fully understood, but it is generally believed that gradually introducing increasing amounts of the mite allergen helps train the immune system to be less reactive, reducing allergy symptoms over time.

💊How it's taken

Dosing is highly individualized and must be determined by a physician based on skin test results and your sensitivity level.

  • Diagnostic skin testing: Applied cutaneously (scratch or prick-puncture) or intradermally — intradermal testing is only done if the scratch/prick test is negative
  • Immunotherapy injections: Given subcutaneously (under the skin), typically one to two times per week at the start; intervals are gradually extended to every two, three, then four weeks as the maintenance dose is reached
  • If you miss six to eight weeks or more, your dose will need to be reduced — never restart at your previous dose without guidance from your doctor
  • A typical course of immunotherapy is three to five years, though this varies by individual
🤒Side effects — in detail

Most side effects happen at the injection site or as generalized allergic symptoms shortly after the injection.

  • Redness, itching, swelling, or tenderness at the injection site
  • Generalized skin flushing or hives (urticaria)
  • Runny nose or nasal congestion
  • Wheezing
  • Swelling of deeper tissues (angioedema)
  • Nausea, stomach cramps, or diarrhea (less common)
  • Low blood pressure (hypotension)

Severe reactions — including throat swelling (laryngeal edema), anaphylaxis (a life-threatening whole-body allergic reaction), shock, and loss of consciousness — can occur and require immediate emergency treatment. Fatalities have been reported rarely. Always stay in the clinic for at least 20 minutes after each injection.

⚠️Warnings & precautions

Severe and potentially fatal allergic reactions can occur — this is the most important risk. All injections must be given in a medical setting with emergency equipment and trained staff immediately available. People with steroid-dependent or unstable asthma are at the highest risk for life-threatening reactions.

  • Hold or delay injections if you have severe asthma or nasal symptoms, a fever or infection, or have had heavy mite exposure before your scheduled visit
  • When switching to a new lot or type of extract, your dose must be reduced to no more than 25% of your previous dose — potency can vary
  • Beta-blocking drugs can reduce the effectiveness of epinephrine if it is needed in an emergency — your doctor must know if you take these
  • Concentrated extract must always be diluted before use; undiluted concentrate is extremely potent
  • Any local reaction lasting more than 24 hours, or any sign of a systemic (whole-body) reaction, means your next dose must be reduced
🔀What it interacts with

There is one key drug interaction you should know about before starting this treatment.

  • Beta-blocking drugs (such as metoprolol, atenolol, propranolol — used for heart conditions, high blood pressure, or other conditions): these medications can make epinephrine less effective if it is needed to treat a severe allergic reaction to the extract — this is a clinically important safety concern your doctor must be aware of before you start injections

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Previous severe reaction: Do not receive immunotherapy if you have had anaphylaxis (severe whole-body allergic reaction) following prior skin testing, allergy shots, or natural mite exposure
  • Autoimmune disease: May be at risk of worsening symptoms — your doctor must carefully evaluate the benefit-to-risk balance
  • Recent heart attack: Immunotherapy may not be tolerable; requires careful medical evaluation before starting
  • Children with nephrotic syndrome (a serious kidney condition): should probably not receive immunotherapy due to the risk of worsening the kidney condition
  • Bleeding disorders: Injections should not be given if you have a condition that causes abnormal bleeding
  • Beta-blocker users: Tell your doctor — these drugs can interfere with emergency epinephrine treatment if a severe reaction occurs
  • Children and older adults generally tolerate the injections well, but all dosing must still be individualized
🚑If you take too much

If a dose is too large and causes a significant local reaction (swelling, redness, pain at the injection site), it can be treated with oral antihistamines and a cold compress applied to the area — but no further extract should be given until the reaction has completely resolved, and the next dose must be reduced. A severe systemic (whole-body) reaction, such as anaphylaxis, must be treated immediately with epinephrine. Always report any reaction to your doctor before your next scheduled injection.

📡Pharmacodynamics — effects in the body

When used for skin testing, house dust mite extract causes a measurable wheal (raised bump) and erythema (redness) response at the test site within 15 to 20 minutes. The size of this response — measured in millimeters — reflects the degree of allergic sensitivity to mite allergens. For immunotherapy, the measurable goal is a reduction in allergy symptoms over the course of treatment, though the precise biological changes underlying this effect are not fully established.

📦How to store it

Extract should be stored at 2-8°C since higher temperatures may adversely affect stability. Do not freeze.

📄 Written from Dermatophagoides Pteronyssinus / House Dust Mite’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dermatophagoides Pteronyssinus / House Dust Mite — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this shot, and why has my doctor recommended it?
It's an allergenic extract made from house dust mites — tiny organisms found in household dust. If you've been having allergy symptoms like sneezing, runny nose, or asthma triggered by dust, your doctor may use this extract first to confirm you're actually allergic through a skin test, and then to treat the allergy with a series of shots. The shots gradually introduce small amounts of the allergen to help your immune system become less reactive to it over time.
Is it safe? I've heard allergy shots can cause serious reactions.
That's a fair concern, and it's important to be honest with you: yes, serious allergic reactions — including severe ones — can happen, and in rare cases fatalities have been reported. That's exactly why these shots must be given in a medical office with emergency equipment and trained staff on hand, and you're required to stay for at least 20 minutes after each injection. Your dose is carefully calculated based on your individual sensitivity to minimize that risk. The key is making sure you're always injected in a proper clinical setting and that you report any reaction before your next visit.
What side effects should I expect, and when should I call for help?
The most common reactions are local ones — redness, swelling, itching, or mild tenderness right where you got the shot. These can last a few hours up to a couple of days and can usually be managed with a cold pack or an antihistamine. What you want to watch for — and act on immediately — is anything beyond that: trouble breathing, wheezing, a tight throat, hives spreading across your body, dizziness, or feeling faint. If any of those happen, you need emergency help right away. That's why staying in the office for 20 minutes after each shot is so important.
Do I have to come in that often? How long does treatment take?
At first, yes — injections are usually given once or twice a week. But as you build up to your maintenance dose, the visits space out to every two weeks, then three, then eventually once a month. A full course of treatment is typically three to five years, though that varies from person to person. It's a commitment, but the gradual buildup is what makes it work safely.
I take a blood pressure medication called a beta-blocker. Does that matter?
Yes, and it's really important that your doctor knows this before you start. Beta-blockers can make epinephrine — the emergency medication used if you have a severe allergic reaction — less effective than it should be. That doesn't automatically mean you can't receive the shots, but your doctor needs to carefully weigh the risks and plan accordingly. Always keep your prescriber updated on every medication you take.
What happens if I miss a few appointments?
It matters more than you might think. If you go six to eight weeks without an injection, your dose will need to be significantly reduced — sometimes by 75% — before you can continue. If you miss even longer, you may need to step back several dose levels. This isn't a punishment; it's because your tolerance to the extract can decrease during a gap. So try to keep your appointments, and always call your doctor's office if you have to miss one so they can plan the right next step for you.
Is Dermatophagoides Pteronyssinus / House Dust Mite available over the counter?
Dermatophagoides Pteronyssinus / House Dust Mite is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dermatophagoides Pteronyssinus / House Dust Mite first available?
Dermatophagoides Pteronyssinus / House Dust Mite has been available in the United States since at least 1986, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Dermatophagoides Pteronyssinus / House Dust Mite’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Dermatophagoides Pteronyssinus / House Dust Mite comes

Dermatophagoides Pteronyssinus / House Dust Mite is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into the skin · On the skin · Under the skin
Brands House Dust Mite, Dermatophagoides farinae
How this form is used
What it may be used for
  • Used cutaneously (scratch or prick-puncture) or intradermally to diagnose mite allergy through skin testing
  • Used by subcutaneous injection for immunotherapy (allergy shot treatment) in patients with confirmed mite allergy
  • Intradermal testing is only performed after a scratch or prick-puncture test has been done with a negative result
Important instructions
  • Must never be injected intravenously — subcutaneous and intradermal routes only for treatment and diagnostic testing
  • The concentrate must be diluted before use for intradermal skin testing or therapeutic injection; never use undiluted concentrate directly on a patient
  • For subcutaneous immunotherapy, injections are typically given one to two times per week initially, with intervals gradually extended to every four weeks at maintenance — follow your prescriber's exact schedule
  • Stay at the clinic for at least 20 minutes after every injection so you can be monitored for reactions
Available strengths 1 strength
2 FDA-listed product records

📊 Dermatophagoides Pteronyssinus / House Dust Mite across the U.S. market

How Dermatophagoides Pteronyssinus / House Dust Mite appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
2
FDA-listed product records
1986
First marketed

🔍 Compare Dermatophagoides Pteronyssinus / House Dust Mite products

A representative set of FDA-listed product records for Dermatophagoides Pteronyssinus / House Dust Mite — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
10000 [AU]/mL Cutaneous, Intradermal, Subcutaneous Allermed Laboratories, Inc. BLA View NDC →
10000 [AU]/mL Cutaneous; Intradermal; Subcutaneous Allermed Laboratories, Inc. BLA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Dermatophagoides Pteronyssinus / House Dust Mite NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Dermatophagoides Pteronyssinus / House Dust Mite RxCUI 1116982 2 dose forms · 3 strengths
  1. Dose form (SCDF) Sublingual Tablet RxCUI 1998623 No current FDA listing
    Clinical drug / strength (SCD) American house dust mite allergenic extract 6 SQ-HDM / European house dust mite allergenic extract 6 SQ-HDM RxCUI 1998624

Look up RxCUI 1116982 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏭 Manufacturers & labelers

Allermed Laboratories, Inc. 2

RxNorm drug class

Dermatophagoides Pteronyssinus / House Dust Mite belongs to the Standardized Insect Allergenic Extract class.

Pharmacologic class Standardized Insect Allergenic Extract

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 3, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dermatophagoides Pteronyssinus / House Dust Mite.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dermatophagoides Pteronyssinus / House Dust Mite after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label
Allermed Laboratories, Inc.
Linked label effective
Jun 3, 2025
Composite sections available
11
Linked SPL Set ID
3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6
Linked SPL Document ID
36ad59b6-cc4b-fe11-e063-6394a90ac650
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Allermed Laboratories, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.