⛔
Regulatory ban. This ingredient is banned or restricted in one or more countries. See Regulatory Status below.
⚠️
Major drug interaction. This ingredient has clinically significant drug interactions. See Drug Interactions below before use.
SAFE

berberine

Macrolide antibiotics
Possibly Safe V1 Verified
Scan supplement →
PubMed Studies
135
PubChem CID
About

Monitor for increased side effects of both compounds

How it works (mechanism of action)

Activates AMPK via mitochondrial Complex I inhibition, mimicking metformin. Downregulates PCSK9 increasing hepatic LDL receptor expression. Inhibits CYP3A4, CYP2D6, and P-glycoprotein. Stimulates GLP-1 secretion from intestinal L-cells.

⚖️ Regulatory Status
⛔
SG — Banned
HSA Singapore prohibition (2004) — ephedra alkaloid supplements prohibited.
⛔
MY — Banned
NPRA Malaysia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
NL — Banned
NVWA prohibition (2004).
⛔
NZ — Banned
Medsafe NZ — ephedrine alkaloid supplements banned following FDA and TGA action.
⛔
AE — Banned
UAE MOH prohibition — ephedra supplements banned. Ephedrine controlled as pharmaceutical.
⛔
PH — Banned
FDA Philippines — ephedra and ephedrine alkaloid-containing food supplements banned following international regulatory action.
⛔
ID — Banned
BPOM Indonesia — ephedra and ephedrine alkaloid supplements prohibited.
⛔
PL — Banned
GIS Poland prohibition aligned with EU Directive 2002/46/EC.
⛔
PT — Banned
ASAE Portugal prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
SA — Banned
SFDA Saudi Arabia — ephedra and ephedrine alkaloid supplements prohibited. Controlled as prescription drug.
⛔
SE — Banned
Livsmedelsverket Sweden prohibition aligned with EU Directive 2002/46/EC.
⛔
ES — Banned
AEMPS Spain prohibition aligned with EU ban on ephedrine alkaloid supplements.
⛔
DK — Banned
Banned (2023) — Danish Veterinary and Food Administration (DVFA). Liver toxicity and thyroid disruption reports. All preparations ordered off market.
⛔
DE — Banned
BfArM banned kava-containing products in Germany in 2002 due to hepatotoxicity risk. Cases of liver failure and death reported.
⛔
CH — Banned
Swissmedic banned kava in Switzerland due to hepatotoxicity.
⛔
BE — Banned
FASFC Belgium prohibition aligned with EU Directive 2002/46/EC.
⛔
US — Banned
FDA issued warning letter against oral comfrey products. Contains pyrrolizidine alkaloids causing liver damage.
⚠️
IN — Restricted
CDSCO India (2004) — available only under prescription as pharmaceutical products.
⚠️
TH — Restricted
FDA Thailand — ephedrine controlled as pharmaceutical. Not permitted in food supplements.
⚠️
TW — Restricted
TFDA Taiwan — ephedrine controlled as pharmaceutical drug. Not permitted as health food ingredient. Products with ephedra claims require pharmaceutical registration.
⚠️
ZA — Restricted
SAHPRA (2004) — Schedule 2; pharmacist oversight required.
⚠️
KR — Restricted
MFDS South Korea (2003) — maximum dose restrictions. Not permitted for weight loss products.
⚠️
JP — Restricted
MHLW Japan (2003) — maximum dose limits; not permitted for weight loss marketing. Ephedrine controlled under pharmaceutical regulations.
⚠️
IT — Restricted
Italian Ministry of Health — berberine supplements restricted to max 10mg/day without medical supervision.
⚠️
IE — Restricted
FSAI monitoring (2024) following Danish ban and hepatotoxicity reports. Products without adequate safety data may face withdrawal.
⚠️
HK — Restricted
Department of Health Hong Kong — ephedrine-containing preparations controlled as pharmaceutical products. Not permitted as health food supplements without pharmaceutical registration.
⚠️
GB — Restricted
MHRA (2004) — ephedrine alkaloid supplements restricted. Maximum doses apply under the Medicines Act.
⚠️
FR — Restricted
ANSES (2013) — maximum dose restrictions following EFSA genotoxicity concerns.
⚠️
EU — Restricted
EFSA (2023) — safety concerns at commonly marketed doses (>0.9mg/day). Several EU member states restricting high-dose products. EMA/HMPC review ongoing. [source ↗]
⚠️
CN — Restricted
NMPA China — berberine (berberine hydrochloride) registered as pharmaceutical (OTC drug) for specific indications. Not permitted as general health food ingredient at pharmaceutical doses.
💊
CA — Prescription only
DHEA is a controlled substance in Canada, available by prescription only.
💊
AU — Prescription only
DHEA is scheduled as a prescription-only medicine in Australia (Schedule 4).
💊
AT — Prescription only
AGES Austria — melatonin classified as prescription-only medicinal product. Not permitted as food supplement.
ℹ️
EU — Monitored
EFSA assessed berberine: no health claims approved. Potential drug interactions via CYP3A4. Not recommended in pregnancy. [source ↗]
📊 Effectiveness
Blood sugar control
Evidence Grade A · 28 studies · n=3,800 · Meta-analysis available
Effective
Type 2 diabetes
Evidence Grade B · 14 studies · n=842 · Meta-analysis available
Possibly Effective
Cholesterol reduction
Evidence Grade B · 11 studies · n=620
Possibly Effective
Weight management
Evidence Grade B · 14 studies · n=1,800
Possibly Effective

Evidence grades: A=Strong RCT evidence · B=Good clinical trials · C=Limited trials · D=Preliminary/traditional

👥 Safety by Population
PopulationSafety RatingMax Safe Dose
DiabetesPossibly safe500mg 2-3x/day under medical supervision
GeneralPossibly safe1500mg/day
PregnancyPossibly unsafeAvoid
🚫 Contraindications & Warnings

Consult a healthcare professional before use if pregnant, breastfeeding, taking prescription medications, or if you have a medical condition. Keep out of reach of children.

💊 Drug Interactions (14)
🔴 Cyclosporine
Major
Immunosuppressants
Management: AVOID in transplant patients. If unavoidable, monitor cyclosporine levels closely.
🔴 CYP3A4 substrates
Major
Multiple drug classes
Management: Significant interaction potential. Review all medications before starting berberine. Avoid with cyclosporine and tacrolimus.
🔴 Tacrolimus
Major
Immunosuppressants
Management: Contraindicated in transplant patients. Nephrotoxicity and neurotoxicity risk.
🔴 Metformin / Insulin
Major
Antidiabetics
Management: Requires blood glucose monitoring. May need antidiabetic dose reduction.
🔴 Digoxin
Major
Cardiac glycosides
Management: Monitor digoxin levels closely. Toxicity risk.
🟡 Metformin
Moderate
Biguanides (diabetes)
Management: Monitor blood glucose closely. Dose reduction of metformin may be required.
🟡 Warfarin
Moderate
Anticoagulant
Management: Monitor INR closely when berberine is added or removed from therapy.
🟡 Simvastatin / Lovastatin
Moderate
Statins
Management: Monitor CK and LFTs. Statin dose reduction may be needed. Myopathy risk.
🟡 Amlodipine / Nifedipine
Moderate
Calcium channel blockers
Management: Monitor BP. May require antihypertensive dose reduction. Hypotension risk.
🟡 Fluoxetine / SSRIs
Moderate
Antidepressants
Management: Monitor for increased SSRI side effects and serotonergic effects.
🟡 Metoprolol
Moderate
Beta-blockers
Management: Monitor heart rate and BP. Bradycardia risk.
🟡 Levothyroxine
Moderate
Thyroid medications
Management: Avoid in hypothyroidism. Monitor TSH during supplementation.
🟡 Aspirin / Clopidogrel
Moderate
Antiplatelet drugs
Management: Monitor for bleeding. Caution with dual antiplatelet therapy.
🟡 Docetaxel / Paclitaxel
Moderate
Chemotherapy
Management: Avoid during active chemotherapy. Consult oncologist.
⚠️ Adverse Effects (1)
Nausea and GI upset
common initially Mild
Gastrointestinal system
Very common at start of treatment. Take with meals, start with 500mg/day and titrate up.
Products containing this ingredient (4)
🏷️ Other Names
Berberine HCl Berberine hydrochloride Berberine (from Berberis)
References (7)
  1. Olsson AG, et al. Eur Heart J Suppl. 2023;25(Suppl A):A1-A10.   SR/Meta-analysis   PubMed ↗
  2. National Institutes of Health. Zinc: Fact Sheet for Health Professionals. 2022. Available from: https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/   Reference   Source ↗
  3. National Institutes of Health. Magnesium: Fact Sheet for Health Professionals. 2022.   Reference   Source ↗
  4. US Food and Drug Administration. Drug Interaction Data. 2020.   Regulatory document   Source ↗
  5. Wessels I, Maywald M, Rink L. Nutrients. 2017;9(12):1286.   SR/Meta-analysis   PubMed ↗
  6. Pratte MA, et al. J Altern Complement Med. 2014;20(12):901-8.   SR/Meta-analysis   PubMed ↗
  7. Abbasi B, et al. J Res Med Sci. 2012;17(12):1161-9.   RCT   PubMed ↗

Evidence grades: SR = Systematic review / meta-analysis (highest) · RCT = Randomized controlled trial · Reg = Regulatory/official guidance

Updated: 2026-04-11
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