What is it used for?
Proteolytic enzyme [Source note 3].
Helps to reduce (symptoms such as) pain, quantity of secretion, inability to perceive smell and stuffy nose from ear, nose and/or throat infections [Source note 4].
Mucolytic enzyme that helps break down mucous [Source note 5].
Helps reduce and/or relieve postoperative cheek swelling and/or pain after dental surgery [Source note 6].
Note: The above uses can be combined on the product label (e.g., Mucolytic enzyme that helps break down mucous and reduce symptoms such as pain, quantity of secretion, inability to perceive smell and stuffy nose from ear, nose or throat infections).
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Proteolytic Enzyme
Note: Liquid and liquid-containing dosage forms (e.g., capsule, soft; spray) are not acceptable as source review category II when serrapeptase/serratiopeptidase is combined with non-enzymatic ingredients as the enzyme activity may be impacted. These products may be submitted as a source review category III.
Reduction of symptoms associated with ear, nose and throat infections; Swelling and pain reduction; Mucolytic enzyme
The only acceptable pharmaceutical dosage forms include enteric-coated capsules, tablets, granules or similar preparations [Source note 2]. The dosage form must be qualified with an additional term to describe the delayed release (e.g. enteric-coated capsules, gastro-resistant tablets, microencapsulated enzymes).
Quantities
Proteolytic Enzyme
Not to exceed 120,000 serratiopeptidase units (SU), per day [Source note 7].
Reduction of symptoms associated with ear, nose and throat infections; Mucolytic enzyme
60,000 - 120,000 serratiopeptidase units (SU), per day [Source note 8].
Swelling and pain reduction
30,000 - 120,000 serratiopeptidase units (SU), per day [Source note 9].
How is it used?
Take 2 hours after a meal [Source note 10].
How long is it used?
Products making a swelling and pain reduction claim (at any dose) and products providing more than 60,000 serratiopeptidase units (SU), per day
Ask a healthcare professional for use beyond 7 days [Source note 11].
Products providing 60,000 or less serratiopeptidase units (SU), per day
Ask a healthcare professional for use beyond 4 weeks [Source note 12].
Warnings and precautions
Ask a healthcare professional if symptoms persist or worsen.
Ask a healthcare professional before use if you are pregnant or breastfeeding
Ask a healthcare professional before use if you have gastrointestinal lesions/ulcers, a kidney or liver disorder, or are having surgery [Source note 13].
Ask a healthcare professional before use if you are taking blood thinners or anti-inflammatory medications [Source note 14].
When should it be avoided?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Possible side effects
Stop use if rash, difficulty breathing, hypersensitivity and/or severe allergy occur [Source note 15].
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Proper name(s) | Source information / Source material(s) |
|---|---|---|---|
|
| Serratia marcescens E-15 | Whole cell |
References: Proper names: source ingredient database 2025;; Common names: source ingredient database 2025; Source information: Al-Khateeb and Nusair 2008.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database. Details of the manufacturing of the enzyme at the raw material stage should include fermentation medium and the isolation process of the active ingredient.
No traces of any antibiotics or their residues, should be detectable in the finished product. The active ingredient may comply with the specifications outlined in the Japanese Pharmacopia (JP XVI) : Serrapeptase.
The specifications must include testing for enzymatic activity of the active ingredient at appropriate stages of formulation and manufacturing using the assay outlined in the current Japanese Pharmacopia (JP XVI) : Serrapeptase.
Where published methods are not suitable for use, manufacturers will use due diligence to ensure that the enzymes remain active to the end of their shelf life indicated on the product label.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- July 25, 2025
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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