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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Plant Allergenic Extract [EPC]
Anise (Pimpinella anisum) allergenic extract is a diagnostic and therapeutic biological agent used to identify and treat specific hypersensitivity reactions. It belongs to the Non-Standardized Plant Allergenic Extract class.
Name
Anise
Raw Name
ANISE
Category
Non-Standardized Plant Allergenic Extract [EPC]
Drug Count
5
Variant Count
5
Last Verified
February 17, 2026
About Anise
Anise (Pimpinella anisum) allergenic extract is a diagnostic and therapeutic biological agent used to identify and treat specific hypersensitivity reactions. It belongs to the Non-Standardized Plant Allergenic Extract class.
Detailed information about Anise
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Anise.
Anise belongs to a class of drugs called Non-Standardized Plant Allergenic Extracts. Unlike 'standardized' extracts (such as those for ragweed or honeybee venom), 'non-standardized' means the extract's potency is not measured by a federally mandated bioequivalent allergy unit. Instead, it is typically prepared according to weight-to-volume (w/v) ratios or protein nitrogen unit (PNU) concentrations. The FDA has permitted the use of these extracts based on historical clinical efficacy, though they are subject to rigorous manufacturing standards under the Center for Biologics Evaluation and Research (CBER).
In a clinical setting, healthcare providers use Anise extracts to confirm a diagnosis of 'Celery-Mugwort-Spice Syndrome,' a cross-reactive allergic condition where patients sensitive to mugwort pollen or celery may also react to spices in the Apiaceae family, including anise, fennel, and coriander. Understanding the pharmacological nature of this extract is vital for patients undergoing allergy testing to ensure accurate diagnosis and safety.
The mechanism of action for Anise allergenic extract is centered on the human immune system's Type I hypersensitivity pathway. When the extract is introduced into the skin via percutaneous (scratch/prick) or intradermal (injection into the skin) methods, the specific allergenic proteins in the anise extract encounter mast cells that have been 'sensitized' with IgE antibodies.
At the molecular level, if the patient is allergic to anise, the IgE antibodies bound to the surface of mast cells and basophils recognize the anise proteins. This recognition triggers 'cross-linking' of the IgE receptors, leading to a process called degranulation. During degranulation, the cells release pre-formed inflammatory mediators, most notably histamine, leukotrienes, and prostaglandins.
In a diagnostic skin test, this release causes a localized 'wheal and flare' reaction—a raised, itchy bump (wheal) surrounded by redness (flare). The size of this reaction allows the healthcare provider to quantify the patient's level of sensitivity. In immunotherapy (allergy shots), the mechanism shifts toward 'immune tolerance.' Repeated, escalating doses of the extract are thought to induce the production of IgG4 'blocking antibodies' and regulatory T-cells, which eventually dampen the IgE-mediated allergic response.
The pharmacokinetic profile of allergenic extracts like Anise differs significantly from traditional oral medications because they are biological proteins administered locally.
Anise allergenic extract is primarily used for the following FDA-recognized clinical purposes:
Off-label, some specialists may use these extracts in customized immunotherapy protocols, though this is less common than for pollen or dust mite allergies.
Anise allergenic extracts are available in the following specialized forms:
> Important: Only your healthcare provider can determine if Anise extract testing is right for your specific condition. Testing must be performed in a clinical setting equipped to handle emergency allergic reactions.
Dosage for Anise allergenic extract is highly individualized and is determined by the healthcare provider based on the patient's history and the specific testing method used.
If used for immunotherapy, the 'Maintenance Dose' is reached through a 'Build-up Phase.' The starting dose is often 0.1 mL of a 1:100,000 or 1:10,000 dilution, increasing weekly until a maintenance dose (typically 0.5 mL of a 1:100 or 1:10 concentration) is achieved.
Anise allergenic extract may be used in children; however, the dosage and concentration are often adjusted. Children may have more reactive skin, and the risk of systemic reactions must be carefully weighed.
No specific dose adjustments are required for patients with kidney disease, as the extract is not cleared by the kidneys in a manner that affects its diagnostic or therapeutic potency.
No specific adjustments are required for liver impairment. The metabolism of allergenic proteins occurs locally and via the lymphatic system, independent of hepatic function.
While the dose remains the same, healthcare providers exercise extreme caution in elderly patients. Older adults are more likely to be taking beta-blockers or ACE inhibitors, which can make an allergic reaction more difficult to treat. Additionally, skin reactivity (the ability to form a wheal) may be reduced in older skin, leading to potential false-negative results.
Anise allergenic extract is never self-administered by the patient for diagnostic purposes. It must be administered by a trained medical professional (usually an allergist or immunology nurse).
In the context of diagnostic testing, a missed appointment simply means the test must be rescheduled. For immunotherapy (allergy shots), a missed dose can disrupt the 'build-up' schedule. If a dose is missed by more than a few days, the healthcare provider may need to reduce the next dose to ensure safety before resuming the escalation.
An 'overdose' in the context of allergenic extracts refers to the administration of too much allergen or too high a concentration, leading to a systemic allergic reaction or anaphylaxis.
If an overdose/systemic reaction occurs, the administration of epinephrine (adrenaline) is the first-line treatment. Healthcare providers will also use antihistamines, corticosteroids, and IV fluids as needed.
> Important: Follow your healthcare provider's dosing instructions. Do not attempt to use any allergenic extract products outside of a supervised medical environment.
Most patients undergoing testing with Anise allergenic extract will experience localized reactions. These are expected and indicate the test is working.
> Warning: Stop the procedure and call for emergency help immediately if you experience any of the following symptoms of anaphylaxis.
For those receiving Anise extract as part of long-term immunotherapy, side effects are generally cumulative but manageable.
While Anise extract specifically may not have a unique black box warning, it falls under the General Black Box Warning for Allergenic Extracts:
Report any unusual symptoms or delayed reactions to your healthcare provider immediately.
Anise allergenic extract is a potent biological substance. It is only intended for use by specialists in allergy and immunology. Patients must provide a full medical history, including all current medications and any history of fainting or severe allergic reactions, before the extract is used.
No FDA black box warnings specifically unique to Anise exist beyond the standard class warning for all allergenic extracts. This class warning emphasizes that these products can cause anaphylaxis and must be administered in a facility equipped with emergency resuscitation equipment, including oxygen, intravenous fluids, and injectable epinephrine.
Generally, Anise extract does not cause drowsiness. However, if a patient experiences a systemic reaction or receives epinephrine, they should not drive or operate machinery until they have fully recovered and been cleared by a physician. Some patients may feel lightheaded after testing due to anxiety or a vasovagal response.
Patients are generally advised to avoid alcohol for several hours before and after allergy testing or immunotherapy. Alcohol can increase blood flow to the skin and potentially enhance the rate of allergen absorption or mask the early symptoms of a systemic reaction.
If a patient experiences a severe systemic reaction, the healthcare provider will carefully re-evaluate the risk-benefit ratio of continuing with Anise extract. Testing is typically a one-time event, but immunotherapy may be discontinued if the reactions are frequent or severe.
> Important: Discuss all your medical conditions, especially respiratory or heart problems, with your healthcare provider before starting Anise extract.
There are no absolute drug-drug contraindications that prevent the use of Anise extract, but certain medications make its use significantly more dangerous:
For each interaction, the primary management strategy is either temporary discontinuation of the interfering drug (like antihistamines) or extreme caution and dose adjustment (like beta-blockers).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially those for blood pressure or allergies.
Anise allergenic extract must NEVER be used in the following circumstances:
These conditions require a careful risk-benefit analysis by the allergist:
Patients should be aware of 'Cross-Sensitivity' risks. Anise belongs to the Apiaceae (Umbelliferae) family. If you have had a life-threatening reaction to any of the following, tell your doctor before anise testing:
> Important: Your healthcare provider will evaluate your complete medical history and current respiratory status before prescribing or administering Anise extract.
FDA Pregnancy Category: C (based on general allergenic extract classification).
There are no adequate and well-controlled studies of Anise extract in pregnant women. Animal reproduction studies have not been conducted. The primary concern during pregnancy is not the extract itself, but the risk of a systemic allergic reaction (anaphylaxis). Anaphylaxis in the mother can cause a sudden drop in blood pressure, leading to placental insufficiency and potential fetal distress or death.
It is not known whether the allergenic proteins or their metabolites are excreted in human milk. Because these are large proteins that are degraded locally, it is highly unlikely they would reach the infant in significant quantities through breast milk. The risk-benefit consideration usually favors continuing immunotherapy if the mother is stable, but new testing is often delayed.
Anise extract is used in children, but with specific considerations. Children may be more prone to 'fright-related' vasovagal reactions.
In patients over 65, the following concerns apply:
No dose adjustments are required. The proteins in Anise extract are not cleared by the kidneys in their active form. However, patients with end-stage renal disease (ESRD) may have altered skin reactivity (uremic pruritus), which can make skin test interpretation difficult.
No dose adjustments are required. Hepatic function does not significantly impact the local immune processing or the degradation of allergenic proteins.
> Important: Special populations require individualized medical assessment and a cautious approach to allergen exposure.
Anise allergenic extract acts as a specific antigen (a substance that triggers an immune response). In sensitized individuals, the extract contains proteins (such as the 2S albumin or profilins) that bind to specific IgE antibodies. These IgE antibodies are 'loaded' onto the high-affinity FcεRI receptors on the surface of mast cells in the skin and basophils in the blood.
Upon binding, the receptors cluster together, triggering an intracellular signaling cascade involving tyrosine kinases (like Syk). This leads to the rapid release of histamine from storage granules and the 'de novo' synthesis of leukotrienes. These mediators cause local vasodilation (redness) and increased capillary permeability (swelling/wheal), which are the hallmarks of the diagnostic response.
| Parameter | Value |
|---|---|
| Bioavailability | N/A (Local administration) |
| Protein Binding | High (to specific IgE and IgG) |
| Half-life | Minutes to hours (protein degradation) |
| Tmax | 15-20 minutes (for skin reaction) |
| Metabolism | Local proteolytic degradation |
| Excretion | Lymphatic clearance |
Anise extract is classified as a Non-Standardized Plant Allergenic Extract. It is part of the broader category of 'Biologicals' and 'Allergenics' used for the diagnosis and treatment of allergic disease. It shares clinical characteristics with other spice extracts like fennel, cumin, and caraway.
Medications containing this ingredient
Common questions about Anise
Anise allergenic extract is primarily used by allergists as a diagnostic tool to determine if a patient has a specific allergy to anise. It is administered through a skin prick test or an intradermal injection to observe the body's immune response. If a patient develops a 'wheal and flare' (a raised, red bump) at the site, it suggests the presence of anise-specific IgE antibodies. This information is crucial for patients with 'Celery-Mugwort-Spice Syndrome,' where they may react to various spices. It helps healthcare providers create a safe diet or treatment plan for the patient.
The most common side effects are localized to the area where the extract was applied or injected. Patients typically experience itching, redness, and a raised bump similar to a mosquito bite within 15 to 20 minutes. These symptoms are actually the intended result of a diagnostic test. Some patients may also notice minor swelling or a 'late-phase' reaction where the area becomes red again several hours later. These local effects usually disappear within 24 hours without treatment, although an ice pack can help with discomfort.
It is strongly recommended to avoid alcohol for at least 24 hours before and after receiving Anise allergenic extract. Alcohol can cause vasodilation (opening of the blood vessels), which may increase the rate at which the allergen is absorbed into your system, potentially increasing the risk of a severe reaction. Furthermore, alcohol can mask the early warning signs of anaphylaxis, such as flushing or dizziness, making it harder for medical staff to treat you. Always follow the specific pre-test instructions provided by your allergy clinic. Talk to your doctor if you have concerns about alcohol use.
Anise allergenic extract is generally avoided during pregnancy, especially for diagnostic skin testing. While the extract itself is not known to be a teratogen (substance that causes birth defects), the risk of a systemic allergic reaction (anaphylaxis) poses a danger to both the mother and the fetus. Anaphylaxis can lead to a sudden drop in blood pressure and reduced oxygen flow to the placenta. If a patient is already on a stable dose of allergy shots (immunotherapy), a doctor may choose to continue treatment but will typically not start new testing or increase the dose until after delivery.
For diagnostic purposes, Anise extract works very quickly. A skin prick test usually produces a visible result within 15 to 20 minutes. This is known as the 'immediate hypersensitivity' window. If the test is being used as part of immunotherapy (allergy shots) to build tolerance, the process is much slower. It can take several months of weekly injections during the 'build-up phase' before a patient notices a reduction in their allergy symptoms. The full benefits of immunotherapy are often not realized until the patient has been on a maintenance dose for 6 to 12 months.
Since Anise extract is most often used as a one-time diagnostic test, 'stopping' it is not usually an issue. However, if you are receiving Anise extract as part of a long-term immunotherapy program, you should not stop the injections without consulting your allergist. Stopping suddenly will cause your immune tolerance to fade over time, and your allergy symptoms may return. If you miss several doses and then try to resume at the same high dose, you may be at an increased risk for a severe allergic reaction. Your doctor will provide a safe schedule for tapering or restarting if necessary.
If you miss a scheduled skin test, you simply need to reschedule with your allergist. If you are on an immunotherapy (allergy shot) schedule and miss a dose, contact your doctor's office immediately. Do not attempt to 'double up' on your next dose. Depending on how long it has been since your last injection, your doctor may need to repeat your previous dose or even reduce the dose slightly to ensure your safety. Maintaining a consistent schedule is the best way to ensure the treatment is both safe and effective.
There is no clinical evidence to suggest that Anise allergenic extract causes weight gain. Unlike some other medications, such as oral corticosteroids or certain antidepressants, allergenic extracts are biological proteins administered in very small quantities. They do not affect the metabolic processes or appetite centers that lead to weight changes. If you experience unexpected weight gain while undergoing allergy treatment, you should discuss this with your healthcare provider to identify other potential causes, such as lifestyle changes or other medications.
Anise extract can interact with several types of medications, although not in the traditional way. The most important medications to discuss with your doctor are antihistamines, which must be stopped before testing because they block the test's results. More importantly, medications like beta-blockers and ACE inhibitors can make an allergic reaction to the extract much more dangerous and difficult to treat. Always provide your allergist with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are currently taking before any extract is administered.
Allergenic extracts like Anise are biological products rather than standard chemical drugs, so the term 'generic' is not used in the same way. However, several different biological manufacturers produce Anise (Pimpinella anisum) extracts. While they are essentially the same product, they are 'non-standardized,' meaning the potency might vary slightly between different brands. Because of this, allergists prefer not to switch between different manufacturers' extracts once a patient has started a treatment course, as it could increase the risk of a reaction.