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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Food Allergenic Extract [EPC]
Viola Odorata Flower is a non-standardized allergenic extract used primarily for the diagnosis and treatment of hypersensitivity to the Sweet Violet plant. It belongs to the class of non-standardized plant and food allergenic extracts.
Name
Viola Odorata Flower
Raw Name
VIOLA ODORATA FLOWER
Category
Non-Standardized Food Allergenic Extract [EPC]
Drug Count
4
Variant Count
4
Last Verified
February 17, 2026
About Viola Odorata Flower
Viola Odorata Flower is a non-standardized allergenic extract used primarily for the diagnosis and treatment of hypersensitivity to the Sweet Violet plant. It belongs to the class of non-standardized plant and food allergenic extracts.
Detailed information about Viola Odorata Flower
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Viola Odorata Flower.
Viola Odorata Flower, commonly known as the Sweet Violet, is a species of the genus Viola native to Europe and Asia. In the clinical and pharmacological landscape, Viola Odorata Flower is utilized as an allergenic extract. It belongs to the pharmacological class known as Non-Standardized Plant Allergenic Extracts [EPC] and Non-Standardized Food Allergenic Extracts [EPC]. These extracts are complex biological mixtures derived from the flowers of the Viola odorata plant, containing various proteins, glycoproteins, and polysaccharides that can trigger immune responses in sensitized individuals.
Under the regulatory framework of the U.S. Food and Drug Administration (FDA), allergenic extracts like Viola Odorata Flower are classified as biological products. Unlike standardized extracts (such as those for certain grasses or dust mites), non-standardized extracts do not have a defined potency relative to a U.S. Reference Standard. Instead, their strength is typically expressed in terms of Weight/Volume (W/V) or Protein Nitrogen Units (PNU). These products have been used for decades in the field of allergy and immunology for both diagnostic skin testing and therapeutic allergen immunotherapy (SIT).
The mechanism of action for Viola Odorata Flower extract depends on its clinical application. In diagnostic settings, such as percutaneous (prick/puncture) or intradermal skin testing, the extract is introduced into the skin. If the patient has pre-existing Immunoglobulin E (IgE) antibodies specific to the proteins in the Viola odorata flower, these antibodies, which are bound to the surface of mast cells and basophils, will cross-link upon contact with the allergen. This cross-linking triggers the degranulation of these cells, releasing inflammatory mediators like histamine, leukotrienes, and prostaglandins. This results in a localized "wheal and flare" reaction (a raised bump surrounded by redness), which clinicians use to confirm a Type I hypersensitivity (allergic) profile.
In therapeutic applications, known as allergen immunotherapy or "allergy shots," the extract is administered subcutaneously (under the skin) in gradually increasing doses. This process aims to induce immunological tolerance. The molecular mechanism involves a shift in the immune response from a Th2-dominated profile (associated with allergy and IgE production) to a Th1-dominated profile. This shift increases the production of regulatory T-cells (Tregs) and the secretion of Interleukin-10 (IL-10) and Transforming Growth Factor-beta (TGF-β). Furthermore, immunotherapy stimulates the production of "blocking antibodies," specifically IgG4, which compete with IgE for allergen binding, thereby preventing the allergic cascade upon natural exposure to the plant.
Traditional pharmacokinetic studies (Absorption, Distribution, Metabolism, and Elimination) are not typically conducted for allergenic extracts like Viola Odorata Flower, as they are biological mixtures of proteins rather than small-molecule drugs.
Viola Odorata Flower allergenic extract is primarily indicated for:
Viola Odorata Flower is available in the following dosage forms:
> Important: Only your healthcare provider can determine if Viola Odorata Flower is right for your specific condition. Testing and treatment must be performed by a qualified allergist or immunologist in a clinical setting equipped to handle emergency reactions.
Dosage for Viola Odorata Flower allergenic extract is highly individualized and must be determined by a physician based on the patient's sensitivity level and clinical history.
Immunotherapy involves two distinct phases:
Viola Odorata Flower extract may be used in children; however, the safety and efficacy have not been established in very young children (typically under age 5). Dosing follows the same principles as adult dosing, but extreme caution is required. Children may be at a higher risk for systemic reactions, and their inability to communicate early symptoms of anaphylaxis must be considered. Dose adjustments are based on the child's specific sensitivity rather than weight-based calculations.
No specific dose adjustments are provided in the manufacturer's labeling for renal impairment. However, clinicians should monitor patients closely, as overall health status can influence the body's ability to recover from a potential systemic reaction.
No specific dose adjustments are required for hepatic impairment. The metabolism of the proteins in the extract is not primarily dependent on hepatic CYP450 enzymes.
Geriatric patients (over 65 years) should be evaluated carefully. The presence of comorbid conditions, such as cardiovascular disease, may increase the risk of complications if a systemic reaction occurs. Furthermore, many elderly patients take beta-blockers, which are a relative contraindication for immunotherapy.
This medication is never self-administered by the patient. It must be administered by a healthcare professional in a clinical setting.
If a dose of immunotherapy is missed, the next dose may need to be reduced depending on how much time has passed.
An overdose of allergenic extract (either too much volume or too high a concentration) significantly increases the risk of a severe systemic reaction or anaphylaxis.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most patients undergoing skin testing or immunotherapy with Viola Odorata Flower extract will experience some form of local reaction. These are generally not dangerous but indicate the body's immune response to the allergen.
> Warning: Stop taking Viola Odorata Flower and call your doctor immediately if you experience any of these.
There are no known long-term adverse effects associated with the proper use of Viola Odorata Flower allergenic extract. Immunotherapy is designed to change the immune system's long-term behavior. In some cases, patients may develop a persistent nodule (a small, hard lump) at the injection site if the extract is injected too superficially or if the patient has a sensitivity to the aluminum salts sometimes used as adjuvants in other extracts (though Viola Odorata is typically aqueous or glycerinated).
Allergenic extracts, including Viola Odorata Flower, can cause severe life-threatening systemic reactions, including anaphylaxis.
Report any unusual symptoms to your healthcare provider.
Viola Odorata Flower allergenic extract is intended only for use by clinicians trained in allergy and immunology. It is not for self-administration. The most critical safety concern is the risk of a systemic allergic reaction, which can occur even in patients who have previously tolerated the extract without issue.
No FDA black box warnings are specifically unique to Viola Odorata Flower beyond the standard class-wide warning for all allergenic extracts regarding the risk of anaphylaxis. As stated in the Side Effects section, this warning emphasizes that administration must occur in a medical facility with emergency resuscitation capabilities.
Generally, Viola Odorata Flower extract does not cause drowsiness. However, if a patient experiences a mild systemic reaction or is given an antihistamine to treat a local reaction, their ability to drive or operate machinery may be impaired. Patients should ensure they feel completely normal before leaving the clinic.
Alcohol consumption should be avoided for several hours before and after an allergy injection. Alcohol causes vasodilation (widening of the blood vessels), which can increase the rate of allergen absorption and potentially trigger or worsen a systemic reaction.
Immunotherapy is typically discontinued if:
> Important: Discuss all your medical conditions with your healthcare provider before starting Viola Odorata Flower.
There are no known direct food interactions with Viola Odorata Flower extract. However, patients with a known food allergy to members of the Violaceae family should inform their doctor, as cross-reactivity is possible. It is recommended to avoid heavy meals immediately before an injection to prevent confusion between food-induced GI distress and an allergic reaction.
Viola Odorata Flower extract does not typically interfere with standard blood chemistry or hematology tests. However, it will directly affect:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients who are highly allergic to other members of the Viola genus (such as Pansies or Violets) may show cross-sensitivity to Viola Odorata Flower extract. Caution should be exercised if the patient has had previous severe reactions to any plant-based allergenic extracts.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Viola Odorata Flower.
Viola Odorata Flower extract is classified as FDA Pregnancy Category C. This means that animal reproduction studies have not been conducted, and it is not known whether the extract can cause fetal harm or affect reproduction capacity.
It is not known whether the components of Viola Odorata Flower extract or the antibodies produced during immunotherapy are excreted in human milk. Because most proteins are digested in the infant's gastrointestinal tract, the risk to a nursing infant is considered low. However, breastfeeding mothers should be monitored, and the decision to continue treatment should be made jointly by the patient and the physician.
Allergen immunotherapy is generally considered safe for children ages 5 and older.
Clinical studies of Viola Odorata Flower extract did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
There is no evidence that renal impairment significantly alters the safety or efficacy of Viola Odorata Flower extract. However, in patients with end-stage renal disease, the physiological reserve to handle a systemic reaction may be diminished.
Since the extract consists of proteins that are metabolized by general cellular processes rather than specific hepatic enzymes, liver disease is not expected to affect the pharmacology of the drug. However, severe hepatic impairment (Child-Pugh Class C) may affect overall immune function.
> Important: Special populations require individualized medical assessment.
Viola Odorata Flower extract works by modulating the immune system's response to the Viola odorata allergen. In an allergic individual, exposure to the allergen results in the cross-linking of IgE antibodies on mast cells, leading to the release of histamine. Immunotherapy with this extract induces the production of IgG4 blocking antibodies. These IgG4 antibodies have a higher affinity for the allergen than IgE, effectively "mopping up" the allergen before it can reach the mast cells. Furthermore, the extract promotes the development of Regulatory T-cells (Tregs), which suppress the Th2-mediated allergic inflammation and promote a more tolerant Th1-mediated immune environment.
| Parameter | Value |
|---|---|
| Bioavailability | N/A (Subcutaneous/Intradermal) |
| Protein Binding | N/A (Biological proteins) |
| Half-life | Variable (Hours to Days for proteins) |
| Tmax | 15-30 minutes (Local reaction) |
| Metabolism | Proteolysis by endogenous enzymes |
| Excretion | Renal/Metabolic |
Viola Odorata Flower is classified as a Non-Standardized Plant Allergenic Extract. It is grouped with other floral and pollen extracts used in the diagnosis and treatment of seasonal allergies. Unlike medications like antihistamines or corticosteroids, which treat the symptoms of allergy, this extract is designed to modify the underlying disease process.
Medications containing this ingredient
Common questions about Viola Odorata Flower
Viola Odorata Flower allergenic extract is primarily used for two purposes: diagnosing and treating allergies to the Sweet Violet plant. In diagnosis, a small amount of the extract is applied to the skin to see if it causes an allergic reaction, which helps identify the cause of symptoms like sneezing or itchy eyes. For treatment, it is used in allergen immunotherapy, commonly known as allergy shots. This involves giving gradually increasing doses of the extract to help the body build a tolerance to the allergen over time. This treatment is usually reserved for patients whose symptoms are not well-controlled by other medications.
The most common side effects of Viola Odorata Flower extract are localized to the site where the extract was applied or injected. Patients frequently experience redness, itching, and a raised bump (wheal) at the site, which is a normal part of the body's immune response. These local reactions usually appear within minutes and typically fade within a few hours. Some patients may also feel slightly fatigued or experience a mild headache after an immunotherapy injection. While these common side effects are usually bothersome rather than dangerous, any large or worsening reaction should be reported to your doctor immediately.
It is strongly recommended to avoid alcohol consumption on the days you receive a Viola Odorata Flower injection. Alcohol can cause your blood vessels to dilate, which might speed up the absorption of the allergen into your bloodstream and increase the risk of a systemic allergic reaction. Furthermore, alcohol can mask some of the early warning signs of an allergic reaction, such as flushing or feeling lightheaded. To ensure your safety during immunotherapy, it is best to refrain from drinking for at least 24 hours around your appointment. Always discuss your lifestyle habits with your allergist.
The use of Viola Odorata Flower extract during pregnancy requires a careful risk-benefit analysis by a healthcare provider. It is generally classified as Pregnancy Category C, meaning its effects on a developing fetus are not fully known. Most allergists will not start a new course of immunotherapy during pregnancy because of the risk of anaphylaxis, which could deprive the baby of oxygen. However, if a woman is already on a stable maintenance dose and becomes pregnant, the treatment may sometimes be continued. You must inform your doctor immediately if you are pregnant or planning to become pregnant while receiving these injections.
The time it takes for Viola Odorata Flower immunotherapy to work varies from person to person, but it is not an immediate fix. Most patients begin to notice a reduction in their allergy symptoms within 6 to 12 months of consistent treatment. During the initial 'build-up phase,' you may not feel much different, as the doses are very small. The full benefits are typically seen once you reach and maintain the 'maintenance dose' for a period of time. A full course of treatment usually lasts between 3 and 5 years to provide long-lasting relief after the injections are stopped.
Yes, you can stop receiving Viola Odorata Flower injections suddenly without experiencing physical withdrawal symptoms like those seen with some other medications. However, stopping immunotherapy prematurely will likely result in the return of your original allergy symptoms, as your body may not have developed full long-term tolerance. If you need to stop treatment due to side effects, cost, or scheduling issues, you should discuss this with your allergist. They can help you determine the best way to manage your allergies moving forward and explain what to expect regarding symptom recurrence.
If you miss a scheduled immunotherapy dose of Viola Odorata Flower, you should contact your allergist's office as soon as possible to reschedule. Missing a dose can affect your treatment schedule and safety. If only a few days have passed, your doctor may give you the usual dose. However, if several weeks have passed, your doctor may need to reduce the dose for your next injection to prevent a systemic reaction, as your body's tolerance may have slightly decreased. It is important not to simply skip doses frequently, as consistency is key to the success of the treatment.
There is no clinical evidence to suggest that Viola Odorata Flower allergenic extract causes weight gain. The extract consists of small amounts of proteins and carbohydrates that do not have metabolic or hormonal effects on body weight. If you experience weight gain while undergoing immunotherapy, it is likely due to other factors, such as lifestyle changes or other medications you may be taking (like oral corticosteroids for asthma). If you have concerns about weight changes, you should discuss them with your primary care physician to identify the underlying cause.
Viola Odorata Flower extract can be taken alongside many medications, but there are some critical exceptions. You must tell your doctor if you are taking beta-blockers, as these can make it very difficult to treat a severe allergic reaction if one occurs. Other medications like ACE inhibitors, MAOIs, and tricyclic antidepressants may also interact with how your body handles an allergic reaction or the emergency treatments for it. Additionally, antihistamines must be stopped several days before skin testing because they can block the test results. Always provide your allergist with a complete list of all your current medications.
The concept of 'generic' vs. 'brand name' is slightly different for allergenic extracts like Viola Odorata Flower compared to standard pills. These extracts are biological products manufactured by various specialized laboratories (such as Greer, ALK, or HollisterStier). While different companies may produce Viola Odorata Flower extract, they are not considered interchangeable in the same way generic drugs are. Each manufacturer's extract may have slightly different protein concentrations. Therefore, if you switch brands, your doctor will usually restart the build-up process or significantly reduce the dose to ensure your safety.