Animal models document hepatic, renal, pulmonary, and CNS toxicity at high dosessupported
In vivo: liver, kidney, lung, brain toxicity. j.jtumed.2024.12.002
Claim in safety — inconclusiveinconclusiveworking →
Kratom is a documented cause of drug-induced liver injury (DILI) with a predominantly cholestatic patternsupported
Predominantly cholestatic histology. RUCAM-assessed causality. Kratom likely causes liver injury based on totality of evidence. s40265-019-01242-6
A comprehensive review of 26 published case reports, 7 DILI Network cases, and 25 FDA database cases found a median latency of 20.6 days from first use to symptom onset (range 2–49 days), with jaundice, pruritus, and dark urine as common presenting featurespartially supported
Scoping review of 26 case reports + 7 DILI Network cases + 25 FDA database + 27 internet cases. Latency 20.6 days (mean). s40265-019-01242-6
RUCAM causality assessment concluded that kratom "likely causes liver injury based on totality of evidence"supported
RUCAM-assessed causality. Kratom likely causes liver injury based on totality of evidence. s40265-019-01242-6
Individual cases have demonstrated cholestatic injury histologically mimicking primary biliary cholangitissupported
Severe cholestatic liver injury from kratom use histologically mimicking primary biliary cholangitis. wjh.v12.i10.863
Nine deaths in Sweden resulted from "Krypton" — kratom powder adulterated with O-desmethyltramadol — with blood levels of 0.02–0.18 µg/g mitragynine and 0.4–4.3 µg/g O-desmethyltramadol; deaths were attributed to synergistic dual mu-opioid-receptor agonismsupported
9 fatal cases in Sweden. Krypton = powdered kratom + O-desmethyltramadol. ODT blood concentrations 0.4-4.3 μg/g. Mitragynine 0.02-0.18 μg/g. Deaths attributed to respiratory depression. pmid:21513619
A fatal case involving hydromorphone and kratom (femoral blood: 79 ng/mL hydromorphone, 560 ng/mL mitragynine) attributed death to hydromorphone toxicity with mitragynine as a contributing factorsupported
Fatal case: 79ng/mL hydromorphone, 560ng/mL mitragynine in femoral blood. Death attributed to hydromorphone toxicity with mitragynine contributing. 1556-4029.15394
The withdrawal syndrome was first systematically characterized in regular Malaysian kratom tea userssupported
First systematic study of kratom dependence, withdrawal, and craving in regular Malaysian users. j.drugalcdep.2014.03.017
A 26-year-old male died of cardiorespiratory failure following suspected kratom use, though pre-existing conditions and polydrug exposure were not fully excludedsupported
26-year-old in cardiorespiratory arrest after kratom use; died from cardiorespiratory failure and hypoxic brain damage. 1751143717712652
Claim in safety — inconclusiveinconclusiveworking →
Synthetic opioid adulterants: O-desmethyltramadol documented in "Krypton" products (9 fatalities); semi-synthetic 7-hydroxymitragynine enrichment in products marketed as botanical kratompartially supported
Krypton = powdered kratom + O-desmethyltramadol. Deaths attributed to respiratory depression. pmid:21513619
Synthetic opioid adulterants: O-desmethyltramadol documented in "Krypton" products (9 fatalities); semi-synthetic 7-hydroxymitragynine enrichment in products marketed as botanical kratompartially supported
7-OH is a potent mu-opioid receptor agonist occurring at trace levels in leaf material but enriched in US market semi-synthetic products. 13880209.2025.2590311
Labeling inaccuracy: Mitragynine content ranges 0.7–38.7% w/w across commercial products, a greater-than-50-fold differencesupported
Mitragynine 0.7-38.7% dta.2604
Higher doses and concentrated 7-hydroxymitragynine products are associated with anxiety, irritability, and — in rare documented cases — psychosissupported
Severe withdrawal from concentrated 7-OH mitragynine: opioid-like symptoms, agitation, psychosis, respiratory compromise requiring intubation. cureus.98386
Chronic kratom use may adversely affect cognitive performance through disruption of neuroplasticity via opioid, serotonergic, and adrenergic receptor interactionssupported
Kratom may adversely affect cognitive performances via disruption in synaptic plasticity and brain activity. Interaction with opioid, serotonergic, adrenergic receptors. j.bbr.2024.115387
Epigenetic mechanisms have been implicated in withdrawal-associated cognitive impairment in animal modelssupported
Epigenetic mechanism implicated in kratom withdrawal behavior and cognitive impairments. bph.16352
Kratom use patterns meeting DSM-5 substance use disorder criteria have been documented, with dose frequency showing a stronger association with dependence severity than dose amount.supported
Study of how dosing amounts/frequencies relate to kratom SUD and physical dependence outcomes. j.drugalcdep.2024.111329
tolerance develops with prolonged and repeated use through μ-opioid receptor mechanisms. Cross-tolerance with classical opioids is documented; buprenorphine can precipitate withdrawal in kratom-dependent patients, confirming clinically significant opioid cross-tolerancepartially supported
Severe withdrawal from concentrated 7-OH mitragynine: opioid-like symptoms, agitation, psychosis, respiratory compromise requiring intubation. cureus.98386
The mitragynine pharmacokinetic half-life is approximately 23 hours; specific tolerance recovery timelines have not been validated in published clinical studies.supported
terminal half-life 23.24 +/- 16.07 h dddt.s79658
Physical dependence liability is highsupported
First systematic study of kratom dependence, withdrawal, and craving in regular Malaysian users. j.drugalcdep.2014.03.017
In studies of 150–170 regular users, cessation produced mild anxiety (70%), mild depression (81%), moderate pain intensity (84%), moderate pain interference (70%), and sleep problems (46%)partially supported
150 regular kratom users in Malaysia: 70% mild anxiety, 81% mild depression on cessation 02791072.2018.1511879
Claim in safety — inconclusiveinconclusiveworking →
Claim in safety — inconclusiveinconclusiveworking →
Withdrawal was characterized as "relatively mild" compared to classical opioid analgesic withdrawal in these studiessupported
effects milder than opioid analgesics 02791072.2018.1443234
Severe withdrawal from concentrated 7-hydroxymitragynine products — including psychosis and respiratory compromise requiring intubation — has been documented in case reports.supported
Severe withdrawal from concentrated 7-OH mitragynine: opioid-like symptoms, agitation, psychosis, respiratory compromise requiring intubation. cureus.98386
{{Recovery}}Withdrawal from botanical kratom leaf at moderate doses is generally manageable without medical interventionsupported
effects milder than opioid analgesics 02791072.2018.1443234
Low-dose sublingual buprenorphine has achieved complete kratom abstinence within 3 weeks in documented casessupported
Low-dose sublingual buprenorphine led to complete abstinence from kratom (containing 7-HMG) within 3 weeks. bcr-2025-265834
Frequency reduction — rather than dose reduction alone — may be a key harm reduction strategy, given that use frequency shows a stronger association with dependence severity than dose amount.{{/Recovery}}supported
Study of how dosing amounts/frequencies relate to kratom SUD and physical dependence outcomes. j.drugalcdep.2024.111329
CYP3A4 inhibition is the best-characterized mechanism: a single 2 g dose of kratom tea increased midazolam (CYP3A probe) AUC by 1.39× (90% CI: 1.23–1.57) and Cmax by 1.50× in 12 healthy adults, consistent with intestinal CYP3A inhibitionsupported
2g kratom tea + midazolam (CYP3A probe): AUC increased 1.39x, Cmax 1.50x. Primarily intestinal CYP3A inhibition. cpt.2891
Physiologically based pharmacokinetic (PBPK) modeling predicts mitragynine increases midazolam exposure 2.2–2.7× with co-administrationsupported
midazolam exposure increases 2.2-2.7x acsptsci.5c00718
CYP2D6 inhibition is demonstrated in vitro (IC₅₀ 0.636 µg/mL) but was not clinically significant at a 2 g kratom dosepartially supported
CYP2D6 (IC50 0.636 ug/mL) molecules16097344
CYP2D6 inhibition is demonstrated in vitro (IC₅₀ 0.636 µg/mL) but was not clinically significant at a 2 g kratom dosepartially supported
No effect on dextromethorphan (CYP2D6). cpt.2891
PXR-mediated enzyme induction with repeated kratom use (CYP3A4, CYP1A2, P-glycoprotein; 3–6-fold activation) creates a paradoxical combination of acute CYP inhibition and chronic CYP inductionsupported
Kratom alkaloids activated PXR 3-6 fold and induced CYP3A4, CYP1A2, P-gp mRNA expression. ptr.5942
Fatal outcomes have been documented with kratom and hydromorphone and kratom products adulterated with O-desmethyltramadolpartially supported
Fatal case: 79ng/mL hydromorphone, 560ng/mL mitragynine in femoral blood. Death attributed to hydromorphone toxicity with mitragynine contributing. 1556-4029.15394
Fatal outcomes have been documented with kratom and hydromorphone and kratom products adulterated with O-desmethyltramadolpartially supported
9 fatal cases in Sweden. Krypton = powdered kratom + O-desmethyltramadol. Deaths attributed to respiratory depression. pmid:21513619
Claim in safety — inconclusiveinconclusiveworking →
Evidence is limited to case reports, but the opioid-like mechanism warrants avoidance during pregnancy and lactation.supported
limited evidence, a few case reports. Opioid-like but not classified as opioid. jmwh.13558
Kratom is a documented cause of drug-induced liver injury and may worsen pre-existing hepatic conditions.supported
Kratom likely causes liver injury based on totality of evidence. s40265-019-01242-6
Additive μ-opioid receptor agonism with documented fatal outcomes in polydrug contexts.supported
Fatal case: 79ng/mL hydromorphone, 560ng/mL mitragynine. Death attributed to hydromorphone toxicity with mitragynine contributing. 1556-4029.15394
Additive μ-opioid receptor agonism with documented fatal outcomes in polydrug contexts.supported
Krypton = powdered kratom + O-desmethyltramadol. Deaths attributed to respiratory depression. pmid:21513619
Kratom inhibits intestinal CYP3A at typical oral doses, potentially elevating co-administered drug plasma concentrations to toxic levels.supported
2g kratom tea + midazolam (CYP3A probe): AUC increased 1.39x, Cmax 1.50x. Primarily intestinal CYP3A inhibition. cpt.2891
Psychiatric history (psychosis): Relative contraindication for concentrated 7-hydroxymitragynine products, which have been associated with psychotic symptoms during withdrawal.supported
Severe withdrawal from concentrated 7-OH mitragynine: opioid-like symptoms, agitation, psychosis, respiratory compromise requiring intubation. cureus.98386
Claim in safety — inconclusiveinconclusiveworking →
Renal impairment was present as a contributing factor in a documented fatal kratom-polydrug case; the large volume of distribution (38 L/kg) suggests altered accumulation dynamics with impaired clearance.partially supported
Vd 38.04 +/- 24.32 L/kg dddt.s79658