Major interaction on record — check this product against your medications before combining. Check your meds →
Dietary supplement

Kava Kava Extract Ingredients & Drug Interactions

by Pure

Capsule Category: Botanical
Most serious interaction: Major
The interaction bottom line Most serious interaction: Major

Kava Kava Extract is a dietary supplement by Pure with 1 active ingredient. Its ingredients are commonly taken for anxiety and stress, restlessness, trouble sleeping.Based on those ingredients, 1,166 medications have a known interaction with it, the most serious rated major. The ingredients most likely to interact are Kava Kava extract. Use the checker below to test your specific medication, or read the full HelloPharmacist Interaction Report.

HelloPharmacist Scorecard of Kava Kava Extract by Pure

Our pharmacy team’s full take, with four database checks built into the cards below — a summary of what is known, not a grade of the product itself.

From our pharmacy team — supplement deep dive

What’s inside

Full disclosure
Ingredient Transparency · database check
Full

Every active ingredient lists its own amount on the label.

Why this rating?
  • The label discloses an exact amount for 1 of its 1 active ingredient.
  • No proprietary blends here — you can verify the dose of every single component.

This product contains one active ingredient: kava kava extract. Kava is a plant from the South Pacific traditionally used for relaxation and social purposes, and modern supplements focus on its kavalactone content — the compounds thought to be responsible for its effects.

The capsule itself is made from gelatin.

Does it work?

Leans against
Evidence for Intended Use · database check
By FDA rules, dietary supplements can’t claim to treat, cure, or prevent disease — so labels speak in careful marketing language. We discern each product’s intended use from its name, label claims, and label statements, then grade the clinical evidence for that use. How these ratings are computed
Leans against

The strongest graded evidence we hold for the stated purpose leans against a benefit.

Why this rating?
  • The label markets this product for: relieve anxiety, promote calmness, and restful sleep.
  • We looked for evidence on: Generalized anxiety disorder (GAD), Stress, Insomnia, Menopausal symptoms, Sleep quality, Relaxation — and 1 related terms.
  • The closest evidence on file: Kava is rated "Possibly Ineffective" for Generalized anxiety disorder (GAD) (Natural Medicines).
  • Also on file: Kava is rated "Insufficient Reliable Evidence To Rate" for Insomnia, Menopausal symptoms, Stress.

The evidence for kava's effectiveness is mixed and limited. For generalized anxiety disorder, the data we hold shows it is possibly ineffective — meaning the evidence doesn't support its use for that purpose.

For insomnia and sexual arousal, there isn't enough reliable evidence to rate whether it works. The bottom line: if anxiety relief is what you're after, the research hasn't borne out that kava delivers it.

The evidence, ingredient by ingredient Kava

How safe is it?

Well-documented data
Safety Information · database check
Well characterized

Adverse-effect, pregnancy, and general safety data are on file for most of these ingredients.

Why this rating?
  • We hold adverse-effect (side-effect) data for 1 of the 1 matched ingredient.
  • Pregnancy & breastfeeding safety ratings cover 1 of 1.
  • General safety write-ups exist for 1 of 1.
  • Remember: this measures how much safety information exists. Thin data is not the same as being safe.

Kava is generally well tolerated in the short term, with common side effects including drowsiness, dry mouth, dizziness, headache, and memory problems. The serious concern is liver injury: over 100 cases of hepatotoxicity have been reported worldwide, particularly with prolonged use or in people who are susceptible — symptoms can appear after just 3 to 4 weeks and include yellowing of skin and eyes.

Some patients have also experienced tremors and involuntary movements. Kava is not safe in pregnancy and should be avoided while breastfeeding because we don't have safety data and it may pass into breast milk.

Side effects, ingredient by ingredient Kava

Meds to double-check

Major interaction found
Known Interaction Concern · database check
Major identified

At least one ingredient has a documented Major-severity interaction. Check your medications for a personalized result.

Why this rating?
  • 1 of the 1 matched ingredient can interact with medications — Kava.
  • The most serious interaction on file is rated Major.
  • For scale: 1,167 individual medications appear in the full list. A big number alone doesn't make a product dangerous — what matters is whether YOUR medication is on it, so run yours through the interaction checker on this page.

Before taking this product, check with your doctor or pharmacist if you take any sedating or CNS depressant medications (sleeping pills, anxiety drugs, opioid painkillers, or alcohol), medications that stress the liver, or drugs processed through the liver enzymes CYP2C19, CYP2C9, CYP2E1, or P-glycoprotein. If you take haloperidol (Haldol) or ropinirole (Requip), do not combine them with kava without talking to your doctor first.

Check your own medication Run your meds through the checker above

The bottom line

Scorecard at a glanceFully disclosed formula with graded evidence leaning against its stated purpose. Major medication interactions have been identified, and safety information is well characterized.

Kava has significant interactions with sedating medications and drugs processed through certain liver pathways, plus a documented risk of liver injury that rises with regular or heavy use. It is not effective for anxiety based on the evidence we hold, is unsafe in pregnancy, and should not be used while breastfeeding.

Before considering this product, talk with your doctor or pharmacist about your full medication list and your liver health.

Educational only — not medical advice; always confirm with your pharmacist. Our editorial policy · How we use AI

Assessment coverage: 1 of 1 active ingredient matched to our full ingredient reviews (monographs). Based on the product label dated Aug 23, 2021.

This Scorecard evaluates available label information, ingredient evidence, and known medication-safety considerations. It does not independently verify product identity, purity, potency, contamination, or manufacturing quality. How these ratings are computed

At a glance

General information

Key facts about Kava Kava Extract, straight from the product label.

Brand Pure
Net contents 365 Capsule(s)
Market status On market
Date entered into DSLD Aug 23, 2021
DSLD ID 248684
Product type Botanical
Supplement form Capsule
Dietary claims / uses All Other, Structure/Function
Intended target group(s) Adult (18 - 50 Years)
From the label
Everything in this section is reproduced from the manufacturer’s own product label — it’s the label speaking, not HelloPharmacist. We show it so you can see exactly what the maker states; we don’t verify or endorse those statements.

Supplement Facts

The label details for Kava Kava Extract by Pure, sourced from the NIH Dietary Supplement Label Database.

Supplement Facts

Daily Value (DV) Target Group(s):
Adults and children 4 or more years of age
Minimum serving Sizes:
1 Capsule(s)
Maximum serving Sizes:
1 Capsule(s)
Servings per container
365
IngredientAmount% DV
Kava Kava extract335 mg--

Other ingredients: Gelatin Capsules

Tap any ingredient to jump to its full detail below.

Label statements
These statements are the manufacturer’s wording, reproduced from the product label — the label is saying it, not HelloPharmacist. We don’t verify or endorse them.
Formulation

Pure ingredients. Pure results.

Triple the value. Unmatched purity.

Non-GMO ingredients

Boost calmness

Stress relief Calm mind Restful sleep

Formula

Pure Kava Kava Extract to relieve anxiety, promote calmness, & gain restful sleep

Precautions

If you are pregnant, nursing, or taking medication, consult your physician before taking this or any dietary supplement.

For adults only.

Suggested/Recommended/Usage/Directions

Suggested Use: Take 1 capsule 1 to 2 times daily, preferably with meals, or as directed by a physician. Take with at least 8 oz of liquid.

Seals/Symbols

Made in USA

Money back guarantee

FDA Statement of Identity

Dietary Supplement

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure or prevent any disease or health condition.

See for yourself

Kava Kava Extract by Pure label

The label scan from the NIH Dietary Supplement Label Database. Tap to enlarge.

What’s inside

The Ingredients in Kava Kava Extract by Pure

This is the 1 active ingredient this product is made of. Select it to open its full monograph.

Serving size1 Capsule(s) Dosage formCapsule Servings per container365 Amounts shown are per serving.

Kava Kava extract

Interacts with
1,166 drugs
335 mg per serving

Kava is a Pacific Island plant traditionally used to promote relaxation and ease anxiety, and some studies suggest it may help mild anxiety. However,...

Kava Kava extract monograph & interactions

Other (inactive) ingredients: Gelatin Capsules. These complete the product’s ingredient list but are not active constituents.

Interaction report

Kava Kava Extract by Pure Drug Interactions

Want to check YOUR meds against Kava Kava Extract?

Ask about interactions with your drugs in plain English — “Can I take it with lisinopril?” — and we find you the answer in seconds, ingredient by ingredient.

Go to the checker
1,166Drugs
248 Major 577 Moderate 341 Minor

Ingredients driving the most interactions

Each ingredient & the kinds of drugs it affects

For each ingredient in Kava Kava Extract with known interactions, here are the types of medications it can affect. Open any type for the detail — or search your exact drug in the checker above.

Kava Kava extract12 drug types · 1,166 drugs

Cns Depressants

Combining kava with CNS depressants can have additive sedative effects.
Kava has CNS depressant effects. Concomitant use of kava with other CNS depressants can increase the risk of drowsiness and motor reflex depression. Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommend that CNS depressants, including alcohol and benzodiazepines, not be used with kava.

Likelihood Probable Evidence A
Alcohol (Ethanol)

Combining kava with alcohol may increase the risk of sedation and/or hepatotoxicity.

Kava has CNS depressant effects. Concomitant use of kava with other CNS depressants can increase the risk of drowsiness and motor reflex depression. Additionally, kava has been associated with over 100 cases of hepatotoxicity. There is some concern that kava can adversely affect the liver, especially when used in combination with hepatotoxic drugs. Clinical practice guidelines from a joint taskforce of the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) recommend that alcohol not be used with kava.

Likelihood Possible Evidence A
Cytochrome P450 2C19 (Cyp2C19) Substrates

Theoretically, kava might increase levels of CYP2C19 substrates.
In vitro research shows that kava significantly inhibits CYP2C19 enzymes. This effect has not yet been reported in humans.

Likelihood Possible Evidence D
Cytochrome P450 2C9 (Cyp2C9) Substrates

Theoretically, kava might increase levels of CYP2C9 substrates.
In vitro research shows that kava significantly inhibits CYP2C9 enzymes. This effect has not yet been reported in humans.

Likelihood Possible Evidence D
Cytochrome P450 2E1 (Cyp2E1) Substrates

Kava might increase levels of CYP2E1 substrates.
In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days inhibited the metabolism of CYP2E1 substrates.

Likelihood Probable Evidence B
Haloperidol (Haldol)

Combining kava and haloperidol might increase the risk of cardiovascular adverse effects and hypoxia.
Atrial flutter and hypoxia has been reported for a patient who received intramuscular injections of haloperidol and lorazepam after using kava orally. The side effects were attributed to kava-induced inhibition of CYP2D6, but might also have been related to additive adverse effects with the concomitant use of haloperidol, lorazepam, and kava.

Likelihood Possible Evidence D
Hepatotoxic Drugs

Theoretically, using kava with hepatotoxic drugs might increase the risk of liver damage.
Kava has been linked with over 100 cases of hepatotoxicity. Most cases occur with excessive and prolonged use. There is some concern that kava can adversely affect the liver, especially when used in combination with hepatotoxic drugs.

Likelihood Possible Evidence D
P-Glycoprotein Substrates

It is unclear if kava inhibits P-glycoprotein (P-gp); research is conflicting.
In vitro research shows that kava can inhibit P-gp efflux. However, a clinical study in healthy volunteers shows that taking kava standardized to provide 225 mg kavalactones daily for 14 days does not affect the pharmacokinetics of digoxin, a P-gp substrate. It is possible that the use of other P-gp substrates or higher doses of kava might still inhibit P-gp.

Likelihood Possible Evidence D
Ropinirole (Requip)

Taking kava with ropinirole might increase the risk for dopaminergic toxicity.
A case of visual hallucinations and paranoid delusions has been reported for a patient who used kava in combination with ropinirole. The adverse effects were attributed to kava-induced inhibition of CYP1A2, which may have reduced the metabolism of ropinirole, resulting in excessive dopaminergic stimulation.

Likelihood Possible Evidence D
Cytochrome P450 1A2 (Cyp1A2) Substrates

It is unclear if kava inhibits CYP1A2; research is conflicting.
Although in vitro research and a case report suggest that kava inhibits CYP1A2, more robust clinical evidence shows that kava has no effect on CYP1A2. In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days had no effect on CYP1A2 activity.

Likelihood Unlikely Evidence B
Cytochrome P450 2D6 (Cyp2D6) Substrates

It is unclear if kava inhibits CYP1A2; research is conflicting.
In vitro research shows that kava extract significantly inhibits CYP2D6. However, clinical research shows that kava does not affect the metabolism of CYP2D6 substrates in humans.

Likelihood Unlikely Evidence B
Cytochrome P450 3A4 (Cyp3A4) Substrates

It is unclear if kava inhibits CYP3AA; research is conflicting.
Although in vitro research suggests that kava inhibits CYP3A4, more robust clinical evidence shows that kava has no effect on CYP3A4. In a clinical study in healthy volunteers, taking kava 1000 mg twice daily (containing a daily dose of 138 mg kavalactones) for 28 days had no effect on CYP3A4 activity.

Likelihood Unlikely Evidence B
The maker

Brand information

Manufacturer and brand details for Kava Kava Extract, from the product label.

Pure

See all Pure products
Name
Pure Supplements
Street Address
2578 W 600 N
City
Lindon
State
UT
ZipCode
84042
Phone Number
801-903-2280
Web Address
Puresupplementsco.com
Pharmacist Counseling Corner

Kava Kava Extract by Pure: Common Questions

Does Kava Kava Extract by Pure interact with any medications?
Yes. Based on its ingredients, Kava Kava Extract has a known interaction with 1,166 medications, including 248 rated major. Use the checker to see how it interacts with a specific drug.
How can one product interact with so many drugs?
Kava Kava Extract contains a single active ingredient, and that one ingredient can interact with many different medications on its own. We check it against each medication and show the mechanism responsible.
Where does this information come from?
The product label data comes from the NIH Dietary Supplement Label Database (DSLD); the interaction data is built on the Natural Medicines database and reviewed by HelloPharmacist pharmacists.
Will kava help my anxiety?
The research we have does not support kava for generalized anxiety disorder — it's rated possibly ineffective for that use. While kava has been traditionally used for relaxation, the modern evidence doesn't show it works for clinical anxiety.
What are the most common side effects?
The most frequent side effects are drowsiness, dry mouth, dizziness, headache, and memory problems. These are usually mild, but drowsiness can be significant if you're also taking other sedating medications.
Is kava safe for my liver?
Kava has been linked to over 100 cases of liver injury worldwide, mostly with long-term or heavy use. Symptoms can show up after as little as 3 to 4 weeks in susceptible people. If you have liver disease or take other liver-damaging medications, kava poses an added risk.
Can I take kava while pregnant or breastfeeding?
No. Kava is not safe in pregnancy and should be avoided. While breastfeeding, there isn't enough safety data, and kava may pass into breast milk, so you should not use it.
Why does kava interact with so many medications?
Kava inhibits several liver enzymes (CYP2C19, CYP2C9, and CYP2E1) that break down many different drugs. When these enzymes are slowed, drugs can build up in your body and cause stronger effects or side effects. It also adds to the sedative effect of any CNS depressant.
Is this product banned?
Kava is banned or restricted in some countries due to liver safety concerns, though it is still available in the United States. The FDA has warned consumers about hepatotoxicity risk.

Written and reviewed by the HelloPharmacist editorial staff. Our editorial policy

Not sure if Kava Kava Extract is safe with your meds?

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Label information is sourced from the NIH Dietary Supplement Label Database and reflects the product version on file; always read your actual product label. This page is for education only and is not a substitute for professional medical advice. Confirm with your pharmacist or doctor before combining supplements and medications.

Kava Kava Extract label
Go deeper

The Full Monographs Behind Kava Kava Extract’s Ingredients

Every ingredient we hold a full HelloPharmacist monograph for — uses, evidence, safety, and the complete interaction list.

Sources

Sources & How We Checked

Kava Kava Extract's label data comes from the NIH Dietary Supplement Label Database; the ingredient interaction data is from the Natural Medicines database, reviewed by our pharmacists.

Content is written and reviewed by licensed HelloPharmacist pharmacists. See our data sources and editorial standards for how this information is built and checked.

The 71 references behind this product’s interaction data

Every citation that drives the interaction findings for this product’s ingredients, from the evidence-graded Natural Medicines (TRC Healthcare) database. Open an ingredient to browse its citations — links open the study on PubMed or the publisher’s site.

Kava 71 references
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  3. Spillane PK, et al. Neurological manifestations of kava intoxication. Med J Aust 1997;167:172-3. PubMed
  4. Swensen JN. Man convicted of driving under the influence of kava. Salt Lake City, UT: Deseret News, 1996.
  5. Pittler MH, Ernst E. Efficacy of kava extract for treating anxiety: systematic review and meta-analysis. J Clin Psychopharmacol 2000;20:84-9. PubMed
  6. Volz HP, Kieser M. Kava-kava extract WS 1490 versus placebo in anxiety disorders--a randomized placebo-controlled 25-week outpatient trial. Pharmacopsychiatry 1997;30:1-5. PubMed
  7. Heinze HJ, Munthe TF, Steitz J, Matzke M. Pharmacopsychological effects of oxazepam and kava-extract in a visual search paradigm assessed with event-related potentials. Pharmacopsychiatry 1994;27:224-30. PubMed
  8. Munte TF, Heinze HJ, Matzke M, Steitz J. Effects of oxazepam and an extract of kava roots (Piper methysticum) on event-related potentials in a word recognition task. Neuropsychobiology 1993;27:46-53.
  9. Wheatley D. Stress-induced insomnia treated with kava and valerian: singly and in combination. Hum Psychopharmacol 2001;16:353-6. PubMed
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  13. Mathews JD, Riley MD, Fejo L, et al. Effects of heavy usage of kava on physical health: Summary of a pilot survey in an aboriginal community. Med J Aust 1988;148:548-55.
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  16. Liver Toxicity With Kava. Pharmacist's Letter/Prescriber's Letter. January 2001.
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  21. Bilia AR, Gallori S, Vincieri FF. Kava-kava and anxiety: growing knowledge about the efficacy and safety. Life Sci 2002;70:2581-97. PubMed
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  23. Mathews JM, Etheridge AS, Black SR. Inhibition of human cytochrome P450 activities by kava extract and kavalactones. Drug Metab Dispos 2002;30:1153-7. PubMed
  24. Logan JL, Ahmed J. Critical hypokalemic renal tubular acidosis due to Sjogren's syndrome: association with the purported immune stimulant echinacea. Clin Rheumatol 2003;22:158-9.
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  26. Schmidt P, Boehncke WH. Delayed-type hypersensitivity reaction to kava-kava extract. Contact Dermatitis 2000;42:363-4.
  27. Schulze J, Raasch W, Siegers CP. Toxicity of kava pyrones, drug safety and precautions--a case study. Phytomedicine 2003;10:68-73.. PubMed
  28. Pittler MH, Ernst E. Kava extract for treating anxiety. Cochrane Database Syst Rev 2003;(1):CD003383.
  29. Cairney S, Maruff P, Clough AR, et al. Saccade and cognitive impairment associated with kava intoxication. Hum Psychopharmacol 2003;18:525-33. PubMed
  30. Moulds RF, Malani J. Kava: herbal panacea or liver poison? Med J Aust 2003;178:451-3. PubMed
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  33. Gurley BJ, Gardner SF, Hubbard MA, et al. In vivo effects of goldenseal, kava kava, black cohosh, and valerian on human cytochrome P450 1A2, 2D6, 2E1, and 3A4/5 phenotypes. Clin Pharmacol Ther 2005;77:415-26. PubMed
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  35. Gurley BJ, Swain A, Barone GW, et al. Effect of goldenseal (Hydrastis canadensis) and kava kava (Piper methysticum) supplementation on digoxin pharmacokinetics in humans. Drug Metab Dispos 2007;35:240-5. PubMed
  36. Gurley BJ, Swain A, Hubbard MA, et al. Clinical assessement of CYP2D6-mediated herb-drug interactions in humans: Effects of milk-thistle, black cohosh, goldenseal, kava kava, St. John's wort, and Echinacea. Mol Nutr Food Res 2008;52:755-63.
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  41. Hannam S, Murray M, Romani L, Tuicakau M, J Whitfeld M. Kava dermopathy in Fiji: an acquired ichthyosis? Int J Dermatol 2014;53(12):1490-4. PubMed
  42. Huynh JC, Asgari MM, Moore MM. Sebotropic eruption associated with use of oral kava kava supplement. Clin Exp Dermatol 2014;39(7):816-8. PubMed
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  44. Scherer, J. Kava-kava extract in anxiety disorders: an outpatient observational study. Adv.Ther. 1998;15(4):261-269.
  45. Humberston, C. L., Akhtar, J., and Krenzelok, E. P. Acute hepatitis induced by kava kava. J Toxicol.Clin Toxicol. 2003;41(2):109-113. PubMed
  46. Schmidt, M. Are kavalactones the hepatotoxic principle of kava extracts? The pitfalls of the glutathione theory. J Altern Complement Med 2003;9(2):183-187. PubMed
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  50. Teschke, R., Genthner, A., and Wolff, A. Kava hepatotoxicity: comparison of aqueous, ethanolic, acetonic kava extracts and kava-herbs mixtures. J.Ethnopharmacol. 6-25-2009;123(3):378-384. PubMed
  51. Jappe, U., Franke, I., Reinhold, D., and Gollnick, H. P. Sebotropic drug reaction resulting from kava-kava extract therapy: a new entity? J Am Acad Dermatol. 1998;38(1):104-106. PubMed
  52. Gessner B and Cnota P. Extract of the kava-kava rhizome in comparison with diazepam and placebo. Z Phytother 1994;15(1):30-37.
  53. Johnson D, Frauendorf A, Stecker K, and et al. Neurophysiological active profile and tolerance of kava extract WS 1490, A pilot study with randomized evaluation. TW Neurolgie Psychiatrie 1991;5(6):349-354.
  54. Keller F and Klohs M. A review of the chemistry and pharmacology of the constituents of Piper methysticum. Lloydia 1963;26:1-15.
  55. Siegers CP, Honold E, Krall B, and et al. Results of the drug monitoring L 1090 with Laitan capsules. Arztl Forsch 1992;39:7-11.
  56. Chanwai, L. G. Kava toxicity. Emergency Medicine 2002;12:142-145.
  57. Leung, N. Acute urinary retention secondary to kava ingestion. Emerg Med Australas 2004;16(1):94. PubMed
  58. Teschke R. Kava hepatotoxicity: pathogenetic aspects and prospective considerations. Liver Int 2010;30(9):1270-9. PubMed
  59. Toohey TP, Lu BY, Wada C. Toxic effects of psychotropics related to possible p450 enzyme inhibition by kava:report of 2 cases. Prim Care Companion CNS Disord 2013;15(5). PubMed
  60. Ostermayer D. News: Kava, Popular as Alcohol Alternative, May Cause Toxicity. Emerg Med News. 2016;38(1B).
  61. Kuchta K, Schmidt M, Nahrstedt A. German Kava Ban Lifted by Court: The Alleged Hepatotoxicity of Kava (Piper methysticum) as a Case of Ill-Defined Herbal Drug Identity, Lacking Quality Control, and Misguided Regulatory Politics. Planta Med. 2015;81(18):16 PubMed
  62. Schmidt M. German Court Ruling Reverses Kava Ban; German Regulatory Authority Appeals Decision. HerbalEGram. 2014;11(7).
  63. Wainiqolo I, Kool B, Nosa V, Ameratunga S. Is driving under the influence of kava associated with motor vehicle crashes? A systematic review of the epidemiological literature. Aust N Z J Public Health 2015;39(5):495-9. PubMed
  64. Wainiqolo I, Kafoa B, Kool B, et al. Driving following kava use and road traffic injuries: a population-based case-control study in Fiji (TRIP 14). PLoS One 2016;11(3):e0149719. PubMed
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  67. Aporosa AS, Atkins M, Brunton R. Kava drinking in traditional settings: towards understanding effects on cognitive function. Hum Psychopharmacol. 2020;35(2):e2725. PubMed
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See these in context on the Kava monograph →

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DISCLAIMER: Currently this does not check for drug-drug interactions. This is not an all-inclusive comprehensive list of potential interactions and is for informational purposes only. Not all interactions are known or well-reported in the scientific literature, and new interactions are continually being reported. Input is needed from a qualified healthcare provider including a pharmacist before starting any therapy. Application of clinical judgment is necessary.

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