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New “Gas Station Heroin” Tianeptine Product Trend

May 8, 2025

Dear Colleagues,

I am writing to draw your attention to a dangerous and growing health trend facing our nation and particularly young people– the increasing number of adverse events involving products containing tianeptine, which can lead to serious harm, including death. Tianeptine, which is often called “gas station heroin” because of its availability in gas station stores, is not approved by the FDA for any use.  

I am very concerned. I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth.  While the FDA is closely following the distribution and sale of these products, it is critical that you appreciate the magnitude of the underlying danger of these products, and disseminate information about it.

Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth.

What is tianeptine?

In some countries, tianeptine is licensed and marketed as an atypical antidepressant. It is believed to act via glutamate modulation and is a full mu- and weak delta-opioid receptor agonist.1 In countries where it is an approved drug, the typical labeled dose to treat depression is 12.5 mg orally three times daily. Higher doses can produce euphoria, and some countries have restricted how tianeptine is prescribed and dispensed or revised the drug label to warn of possible addiction.2  

In the U.S., tianeptine is not currently scheduled under the Controlled Substances Act.  In addition, tianeptine is not approved by the FDA for any medical use, is not generally recognized as safe for use in food, and does not meet the statutory definition of a dietary ingredient. Nevertheless, tianeptine is being marketed as a “research chemical,” a “nootropic” cognitive enhancer, or a dietary supplement.

Tianeptine is frequently available at convenience stores, gas stations, vape shops, and online retailers. Product names include, for example, Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red. Tianeptine has also been referred to as “gas station heroin.” Case reports in the medical literature describe U.S. consumers ingesting daily doses on the order of 1.3 to 250 times (50 mg to 10,000 mg) the daily tianeptine dose typically recommended in labeled foreign drug products.3-11

FDA has taken steps to protect people from tianeptine products, including warning consumers about severe side effects, issuing warning letters to companies distributing and selling unlawful tianeptine products, and placing products on import alert to help detain tianeptine shipments at our borders.

What harms are associated with tianeptine use?

Tianeptine is often taken recreationally, but it has also been used to self-treat a variety of ailments.1,12,13  It is frequently used chronically and, if stopped abruptly, users may experience withdrawal symptoms similar to those associated with opioid discontinuation (e.g., craving, sweating, “goose flesh,” diarrhea, myalgias).

Reported adverse events from ingesting tianeptine include the following:

  • agitation
  • coma
  • confusion
  • death
  • drowsiness
  • hypertension
  • nausea
  • respiratory depression
  • sweating
  • tachycardia
  • vomiting

Tianeptine may not be identified in routine drug screening panels.

In 2024, there was a cluster of illnesses in New Jersey associated with the product “Neptune’s Fix,” which was found to contain tianeptine and synthetic cannabinoid receptor agonists.15 Described adverse events following use of this product include:

  • death
  • hypotension
  • prolonged QT interval
  • seizure
  • tachycardia

What can health care professionals consider?

FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder. As appropriate, health care professionals could also consider talking with patients about evidence-based treatment options for opioid use disorder, depression, anxiety, or pain, and about how to access overdose reversal medicines, including over-the-counter naloxone nasal spray.

FDA recommends that health care professionals who believe a patient is experiencing an adverse event from a tianeptine-containing product contact Poison Help Line (1-800-222-1222) for guidance about clinical management. FDA encourages health care professionals to report adverse events following use of tianeptine-containing products to the FDA. Visit FDA’s MedWatch website to submit a report online or call 1-888-INFO-FDA (1-888-463-6332). To allow FDA to investigate further, please include as much information as possible regarding the product suspected to have caused an adverse event. Pertinent information includes anything found on the product label (e.g., product name, dosage form, active ingredients, strength/concentration, lot number, expiration date, name of manufacturer or distributor). If available, submitting photos of product labeling is encouraged. Additionally, information from the consumer, such as where the product was purchased (website or retail store name/address), will assist FDA investigators with sampling/testing of products.

Health care professionals can direct members of the public to visit FDA’s MedWatch website to report a problem about an FDA regulated product in general.  

Health care professionals can also provide patients, colleagues, or anyone else with FDA’s educational article, “Tianeptine Products Linked to Serious Harm, Overdoses, Death.”

Thank you for your attention to this important matter,

Marty

Martin A. Makary, M.D., M.P.H.

Commissioner of Food and Drugs

References:

  1. Edinoff AN, Sall S, Beckman SP, et al. Tianeptine, an Antidepressant with Opioid Agonist Effects: Pharmacology and Abuse Potential, a Narrative Review. Pain Ther. Oct 2023;12(5):1121-1134. doi:10.1007/s40122-023-00539-5
  2. Springer J, Cubała WJ. Tianeptine Abuse and Dependence in Psychiatric Patients: A Review of 18 Case Reports in the Literature. J Psychoactive Drugs. Jul-Aug 2018;50(3):275-280. doi:10.1080/02791072.2018.1438687
  3. Abouelsaad M, Butler S, Kassem H. 1 A Case of AKI in a Patient With Tianeptine Toxicity. American Journal of Kidney Diseases. 2023;81(4):S1. doi:10.1053/j.ajkd.2023.01.003
  4. Desai S, Hanif S, Silvi S, et al. Tianeptine Abuse Among Adult Attention Deficit Hyperactivity Disorder (ADHD)–A Rare Case Report. Cureus Journal of Medical Science. 2021;
  5. Karim A, Ioannou C. Tianeptine abuse leading to an episode of psychosis: a case report and literature review. Journal of Psychiatric Practice®. 2020;26(2):146-148.
  6. Lauhan R, Hsu A, Alam A, Beizai K. Tianeptine abuse and dependence: case report and literature review. Psychosomatics. 2018;59(6):547-553.
  7. Markovic M, Niwash D. Treatment of concurrent etizolam and tianeptine withdrawal following accidental overdose. Ment Health Clin. Dec 2022;12(6):356-359. doi:10.9740/mhc.2022.12.356
  8. Marraffa JM, Stork CM, Hoffman RS, Su MK. Poison control center experience with tianeptine: an unregulated pharmaceutical product with potential for abuse. Clinical Toxicology. 2018/11/02 2018;56(11):1155-1158. doi:10.1080/15563650.2018.1476694
  9. Shively R ea. Tianeptinewithdrawal following discontinuation of high-dose recreational use. Journal of Medical Toxicology - official journal of the American College of Medical Toxicology 15: 76 abstr. 075, No. 2, Apr 2019. Available from: URL: http://doi.org/10.1007/s13181-019-00699-x [abstract] -USA.
  10. Szczesniak L, Sullivan R. Microdose Induction of Buprenorphine in a Patient Using Tianeptine. J Addict Med. Nov-Dec 01 2022;16(6):736-738. doi:10.1097/adm.0000000000001003
  11. Trowbridge P, Walley AY. Use of Buprenorphine-Naloxone in the Treatment of Tianeptine Use Disorder. J Addict Med. Jul/Aug 2019;13(4):331-333. doi:10.1097/adm.0000000000000490
  12. El Zahran T, Schier J, Glidden E, et al. Characteristics of Tianeptine Exposures Reported to the National Poison Data System - United States, 2000-2017. MMWR Morb Mortal Wkly Rep. Aug 3 2018;67(30):815-818. doi:10.15585/mmwr.mm6730a2
  13. Smith KE, Rogers JM, Strickland JC, Epstein DH. When an obscurity becomes trend: social-media descriptions of tianeptine use and associated atypical drug use. The American Journal of Drug and Alcohol Abuse. 2021/07/04 2021;47(4):455-466. doi:10.1080/00952990.2021.1904408
  14. Lucaj S, Leo RJ. Tianeptine Sodium: A Nootropic With Potentially Lethal Consequences. Prim Care Companion CNS Disord. Jul 19 2018;20(4)doi:10.4088/PCC.17l02205
  15. Counts CJ, Spadaro AV, Cerbini TA, et al. Notes from the Field: Cluster of Severe Illness from Neptune's Fix Tianeptine Linked to Synthetic Cannabinoids - New Jersey, June-November 2023. MMWR Morb Mortal Wkly Rep. Feb 1 2024;73(4):89-90. doi:10.15585/mmwr.mm7304a5
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