Serrapeptase Uses and Dosing Recommendations
Serrapeptase has limited FDA-approved indications for temporary relief of occasional headache, runny nose, nasal or sinus congestion, or dry/itchy skin due to sensitivity to phenolic compounds found in foods or other products. 1
FDA-Approved Dosing
- For adults and children 12 years and over: Take 10 drops under the tongue up to 3 times per day, 30 minutes before or after meals 1
- For children under 12 years: Consult a physician before use 1
Clinical Applications
Anti-inflammatory and Anti-edemic Effects
- Serrapeptase has been studied for its potential anti-inflammatory, anti-edemic, and analgesic properties, though evidence quality is generally poor 2
- Some studies suggest efficacy in reducing post-operative swelling, particularly in oral surgery cases 3, 4
- In a prospective study of ankle swelling after surgery, serrapeptase reduced swelling by 50% by the third post-operative day, which was statistically significant compared to conservative measures (p = 0.013) 3
Dental/Oral Surgery Applications
- Used in some dental practices for post-extraction inflammation management, particularly following impacted third molar surgery 5
- A double-blind, placebo-controlled trial of 174 patients who underwent Caldwell-Luc antrotomy found significantly less buccal swelling in serrapeptase-treated patients compared to placebo (p < 0.01 to p < 0.05) 4
- When compared to dexamethasone for post-extraction inflammation control, dexamethasone was more effective for swelling and pain reduction, though both had similar effects on trismus (limited mouth opening) 5
Important Cautions and Contraindications
Limited Evidence Base
- A systematic review concluded that evidence supporting serrapeptase's use as an anti-inflammatory and analgesic agent is based on clinical studies with poor methodology 2
- Most studies have small sample sizes, unclear outcome definitions, and inadequate reporting of dosing and treatment duration 2
Safety Concerns
- Data on long-term safety is lacking 2
- Serrapeptase should be used with caution in cases of abscess due to its fibrinolytic activity 6
- There is a documented case report of a buccal space abscess spreading into deeper muscular layers after serrapeptase administration 6
Lack of Regulatory Support
- Despite being promoted for various uses, there is insufficient scientific evidence to support serrapeptase's use as an analgesic or health supplement 2
- Evidence-based recommendations on serrapeptase's analgesic efficacy, safety, and tolerability are needed 2
Clinical Decision Algorithm
- Consider serrapeptase only for FDA-approved indications (temporary relief of occasional headache, nasal congestion, etc.) 1
- Use the recommended dosage of 10 drops under the tongue up to 3 times daily for adults and children over 12 years 1
- Avoid use in cases of abscess or infection due to potential for spread of infection 6
- Do not rely on serrapeptase as a primary anti-inflammatory agent when more established options with better evidence are available 2
- Monitor patients closely for any adverse effects, as long-term safety data is lacking 2