✓ No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
⚠ Patient buying generic lavender oil capsules expecting Silexan® results — evidence is brand-specific [1] [2]
⚠ Patient ingesting aromatherapy-grade essential oil — potentially unsafe; oral Silexan® is pharmaceutical-grade [1]
⚠ Parent of prepubertal boy asking about lavender — disclose the gynecomastia case reports for topical products [2]
⚠ Patient expecting immediate anxiolytic effect — onset is 2+ weeks, not hours; this is not a benzodiazepine [1]
🥗 Food first — build your daily Typical 80–160 mg oil
Check the foods you regularly eat — the bar fills toward your daily target.
Lavender tea (1 cup)2 mg linalool (approximate)
Culinary lavender (1 tsp dried)5 mg linalool (approximate)
Herbes de Provence blend (1 tsp)1 mg linalool (approximate)
Check your regular foods above
🔬 Lab interpreter
Recommended test
No routine monitoring required
No routine monitoring required
Reference range / target
N/A
N/A
When to test
N/A
N/A
No hepatotoxicity, QT prolongation, or lab abnormalities reported in RCTs [1].
Full lab monitoring ↓⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
Silexan® (lavender oil) has Level I evidence for GAD — non-inferior to paroxetine in a 539-patient RCT with no sedation, no sexual dysfunction, no withdrawal, and no dependence. The critical point: evidence is brand-specific (Silexan®/WS 1265). Generic lavender oils are NOT interchangeable. At 80 mg/day, this is a legitimate first-line option for mild-to-moderate GAD in patients reluctant to use SSRIs [1].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Insufficient safety data for oral Silexan® in pregnancy. Avoid oral supplementation. Lavender aromatherapy in labor has been used without reported adverse effects [1].
👦 Pediatric: See guidance
No published RCTs of Silexan® in children or adolescents. Lavender aromatherapy has been used in pediatric settings but oral supplementation has no established safety profile in minors [1].
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: Once daily, with or after a meal. Evening dosing may be preferable if any mild drowsiness occurs [1].
💊 With food: Take with food to reduce lavender-flavored eructation (the most common side effect) [1].
🚫 Avoid: Ingesting aromatherapy-grade essential oils (not manufactured for oral use). Combining with multiple sedative supplements without medical guidance [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['Silexan® (WS 1265, oral capsules)', 'preferred', '80 mg standardized lavender oil per capsule. All major RCTs use this specific preparation. Registered pharmaceutical in Germany [1].'] | Standard | Check label | |
| ['Generic lavender oil capsules', 'caution', 'Highly variable linalool/linalyl acetate ratios. Not equivalent to Silexan®. Efficacy data do not transfer [2].', 'orange'] | Standard | Check label | |
| ['Lavender aromatherapy', 'traditional', 'Inhalation of lavender essential oil. Some evidence for acute anxiety/stress reduction but much weaker than oral Silexan® [2].'] | Standard | Check label | |
| ['Lavender tea', 'food', 'Mild relaxant. Negligible linalool absorption compared with standardized oral preparations [2].'] | Standard | Check label |
3 Common questions
Is Silexan® really as effective as paroxetine for anxiety? ▼
In the pivotal 539-patient RCT, Silexan® 80 mg/day was statistically non-inferior to paroxetine 20 mg for GAD over 10 weeks. The key advantages: no sexual dysfunction, no weight gain, no withdrawal syndrome upon stopping. It is a genuine alternative for mild-to-moderate GAD [1].
Can I use lavender essential oil from the health store instead of Silexan®? ▼
The clinical evidence is specific to Silexan® (WS 1265), which has precise linalool/linalyl acetate ratios and pharmaceutical-grade manufacturing. Generic lavender oils vary enormously in composition and are not interchangeable. Do not ingest essential oils intended for external/aromatherapy use [1] [2].
Does lavender cause gynecomastia in boys? ▼
Case reports (2007, 2019) described prepubertal gynecomastia in boys using topical lavender-containing products, attributed to estrogenic and anti-androgenic activity of lavender oil components in vitro. This remains controversial — the in vitro concentrations were far above typical exposure. Oral Silexan® has not been associated with gynecomastia in adult trials [2].
Is Silexan® addictive? ▼
No. Multiple RCTs with abrupt discontinuation showed no withdrawal symptoms, rebound anxiety, or tolerance. This is a major advantage over benzodiazepines and a differentiator from SSRIs (which can cause discontinuation syndrome) [1].
4 Clinical evidence
Strong
Generalized anxiety disorder: a pivotal multicenter RCT (n=539) demonstrated Silexan® 80 mg/day was non-inferior to paroxetine 20 mg/day on the Hamilton Anxiety Rating Scale (HAM-A) over 10 weeks, with significantly fewer adverse effects (no sexual dysfunction, no weight gain, no withdrawal) [1]. Meta-analysis of 5 RCTs (n>1,200) confirmed significant HAM-A reduction vs placebo (WMD −3.8 points) [1]. HIGH
Moderate
Subsyndromal anxiety: Silexan® 80 mg/day significantly reduced anxiety in a 10-week RCT of patients with subsyndromal anxiety (below GAD diagnostic threshold) [1]. Mixed anxiety-depression: one RCT showed improvement in both anxiety and depressive symptoms [1]. Sleep quality: secondary endpoint improvement in most anxiety trials; likely mediated through anxiety reduction rather than direct sedation [1]. MODERATE
Insufficient
5 Safety, toxicity & adverse events
Relative
⚠ Concurrent benzodiazepines or sedatives — additive CNS depression
⚠ Concurrent CYP3A4 substrates — lavender may inhibit CYP3A4
⚠ Pregnancy — avoid oral lavender oil (traditional precaution)
⚠ Prepubertal boys — topical lavender may have endocrine-disrupting effects (case reports of gynecomastia)
🚩 Red flags
● Patient ingesting non-pharmaceutical-grade lavender essential oil — safety not assured [1]
● Parent reporting breast tissue development in prepubertal boy using topical lavender products — evaluate [2]
● Patient expecting Silexan® to work for panic attacks or severe GAD as monotherapy — may need pharmaceutical intervention [1]
6 Interactions
Drug interactions
Paroxetine / SSRIs Low
Mechanism: Silexan® has different mechanism (VDCC, not serotonergic primarily). Minimal pharmacodynamic overlap at standard doses [1].
Effect: No clinically significant interaction reported. May allow SSRI dose reduction under medical supervision [1].
Action: Can potentially be used as transition from SSRI to Silexan® under psychiatric guidance [1].
Benzodiazepines Moderate
Mechanism: Although Silexan® does not act on GABA-A receptors, theoretical additive anxiolytic effect [1].
Effect: No reports of excessive sedation, but caution advised [1].
Action: May allow benzodiazepine taper. Do not combine without medical supervision [1].
Supplement synergies
Magnesium · 200–400 mg elemental Mg
Magnesium deficiency worsens anxiety. Correcting Mg status may enhance Silexan® response [1].
Magnesium deficiency worsens anxiety. Correcting Mg status may enhance Silexan® response [1].
L-Theanine · 200 mg L-theanine
Complementary anxiolytic pathway (glutamate modulation). May provide acute calming while Silexan® builds effect [1].
Complementary anxiolytic pathway (glutamate modulation). May provide acute calming while Silexan® builds effect [1].
7 Regulatory
Germany: Silexan® (Lasea®) is a registered herbal medicinal product approved for treatment of anxiety disorders (restlessness with anxious mood) [1].
European Union: Available as a traditional herbal medicinal product in several EU countries. EMA monograph supports traditional use [1].
United States (FDA): Not FDA-approved. Available as dietary supplement. Branded versions (CalmAid®) sold OTC [1].
Australia (TGA): Listed as complementary medicine for symptomatic relief of mild anxiety [1].
8 US supplement products
5
on-market products containing Lavender (NIH DSLD)
Brands carrying Lavender (5)
Click a brand to see its Lavender products.
9 Frequently paired with
10 References (4)
[1]Kasper S, et al. Lavender oil preparation Silexan is effective in generalized anxiety disorder — a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol. 2014;17(6):859-869. doi:10.1017/S1461145714000017 RCT Accessed: 2026-05-29
[2]Kasper S, et al. Silexan in anxiety disorders: clinical data and pharmacological background. World J Biol Psychiatry. 2018;19(6):412-420. doi:10.1080/15622975.2017.1331046 REVIEW Accessed: 2026-05-29
[3]Woelk H, Schläfke S. A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine. 2010;17(2):94-99. doi:10.1016/j.phymed.2009.10.006 REVIEW Accessed: 2026-05-29
[4]Malcolm BJ, Tallian K. Essential oil of lavender in anxiety disorders: ready for prime time? Ment Health Clin. 2018;7(4):147-155. doi:10.9740/mhc.2017.07.147 REVIEW Accessed: 2026-05-29
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12 Cite this page
Vancouver: Pkhakadze G. Lavender — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Jun 01]. Available from: https://supplement.ge/ingredients/lavender/
APA 7th: Pkhakadze, G. (2026). Lavender — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/lavender/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: December 2026
References: 4 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Lavender — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/lavender/ CC BY 4.0.
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Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG