Tianeptine: What It Is and Why the FDA Warns About It

Tianeptine is a drug, not a supplement. The Food and Drug Administration states that it is not approved for any medical use in the United States [1].

That one fact explains the shape of the problem. A product can sit on a counter next to the energy drinks and still be an unapproved drug. The FDA puts the point bluntly: availability is no indication of effectiveness or safety [1].

Two more things make tianeptine unusual. It acts on opioid receptors, so what it does and what happens when someone stops both look like opioid effects [2]. And the evidence base is poison center calls and case reports rather than trials. This page says which is which.

What follows covers what tianeptine is, how it is sold, what the poison center numbers show, the harms clinicians have reported, one cluster of adulterated products, what an overdose looks like, what withdrawal involves, and what treatment exists. Our hub on drug addiction sets out the wider picture.

What Tianeptine Is, and What It Is Not

It is an antidepressant elsewhere and an unapproved drug here.

The CDC describes tianeptine as an atypical tricyclic drug used as an antidepressant in Europe, Asia, and Latin America [2]. In the United States it is not approved by the FDA for medical use and is an unscheduled pharmaceutical agent [2]. A later CDC report describes its pharmacology as enhancement of serotonin reuptake and mu-opioid receptor agonism [3].

The opioid part is the part that surprises people. Animal and human studies show that tianeptine is an opioid receptor agonist [2]. That is why a drug marketed as a mood product turns up in reports that read like opioid reports.

The FDA has been specific about the regulatory status, and the wording matters if you are reading a label. It has warned consumers that tianeptine is an unsafe food additive, and it states that tianeptine is not a dietary ingredient [1]. It has also issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs, and issued import alerts to detain shipments at the border [1]. Our explainer on the DEA drug schedules covers what scheduling does and does not mean.

How It Is Sold, and Why “Gas Station Heroin” Stuck

The nickname comes from where people find it.

The CDC writes that tianeptine is readily purchased in elixir formulations online or at gas stations informally referred to as “gas station heroin” [3]. It names products sold under several names, including Neptune’s Fix, Pegasus and Zaza [3]. The FDA says it is aware that tianeptine has been sold online in pill, liquid and powder forms [1].

The marketing is the second half of the problem. The FDA states that companies are making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions [1]. Those claims are what bring people to it. Someone self-treating depression, or trying to get off opioids without help, is the reader the FDA is describing.

The FDA’s own advice is short. Consumers should avoid all products containing tianeptine, including those claiming to treat an ailment or disorder [1]. If you need help with opioid dependence, depression, anxiety or pain, talk to a health care provider, because approved treatments for those conditions exist [1].

What the Poison Center Numbers Show

The curve goes one way, and both agencies say so.

The FDA reports that annual poison control center cases involving tianeptine exposure, as reported by the National Poison Data System, have increased nationwide from 4 cases in 2013 to about 350 cases in 2024 [1].

The CDC analysis of the earlier years fills in the shape. Across 2000 to 2017, the National Poison Data System received 218 calls related to tianeptine exposure [2]. Only 11 of those came in the first 14 years of that period [2]. Then the total went to 5 in 2014, 38 in 2015, 83 in 2016 and 81 in 2017 [2]. The CDC calls this a possible emerging public health risk, and that hedge is the agency’s own [2].

Who is calling matters too. Among the exposure calls with an age recorded, the mean age was 35 years, with a range of 1 to 80 years [2]. About half of reported exposures were among people aged 21 to 40 [2].

The Harms Clinicians Have Reported

The reported effects cluster in three body systems.

In the CDC’s series of tianeptine-only exposures, the most commonly reported clinical effects were neurologic in 48.3% of calls, cardiovascular in 32.5% and gastrointestinal in 10.5% [2]. Of the calls where the level of care was recorded, 46 of 105 people were treated, evaluated and released from the emergency department, and 25 were admitted to a critical care unit [2]. No deaths were reported in that series [2].

The FDA’s list is blunter, because it is a warning rather than a tally. It says the serious harmful effects identified from abusing or misusing tianeptine, alone or with other drugs, included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death [1].

If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.

One published case is worth naming carefully. The CDC reported a California man aged 24 with a two-year history of tianeptine misuse who was found unresponsive, developed diffuse white matter damage on brain imaging, and died 19 days after admission [4]. The CDC calls it the first known case of toxic leukoencephalopathy associated with tianeptine, says the finding does not confirm causality, and says no definitive conclusion can be drawn from a single observation [4]. All three of those hedges belong with the case.

If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.

Adulterated Products: The New Jersey Cluster

The label is not the contents, and one cluster showed exactly that.

During June to November 2023 the New Jersey poison center received 20 exposure calls about tianeptine involving 17 patients, against a baseline of two or fewer cases a year [3]. Fourteen of the patients reported taking Neptune’s Fix, a flavored elixir shot sold in small colorful bottles [3].

The clinical picture was severe. All patients had altered mental status on evaluation [3]. Reported effects included tachycardia in 11 patients, hypotension in 10, seizure in eight, prolonged QT interval in seven and cardiac arrest in one [3]. Thirteen of the 17 were admitted to an intensive care unit and seven were intubated [3]. There were no deaths [3].

If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.

Laboratory analysis of six bottles found variable composition, including two synthetic cannabinoid receptor agonists, even though every bottle was labeled as containing only kavain and tianeptine [3]. The CDC keeps its own attribution open: the severity of reported effects might reflect synthetic cannabinoid toxicity, the effects of polysubstance ingestion, or both [3]. The FDA then issued a warning against using Neptune’s Fix or any tianeptine product [3].

Overdose: What It Looks Like and What to Do

Treat it as an opioid overdose until someone with a monitor tells you otherwise.

The reason is the receptor. Tianeptine is an opioid receptor agonist [2], and slowed or stopped breathing and coma are on the FDA’s list of effects [1]. Those are the signs that mean call now.

The CDC’s steps for a suspected overdose are short. If you are not sure whether a person is high or overdosing, treat it like an overdose [5]. Give an overdose reversal medication such as naloxone if one is available and call 911 [5]. Keep the person awake and breathing, lay them on their side to prevent choking, and stay with them until emergency assistance arrives [5].

If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.

On naloxone, the honest answer carries the source’s hedge. The CDC reports that several case reports showed that tianeptine toxicity mimicked opioid toxicity and that naloxone was an effective therapy [2]. Case reports are not a trial. What settles the practical question is a separate CDC statement: naloxone will not harm someone if they are overdosing on drugs other than opioids, so it is always best to use it if you think someone is overdosing [6]. Naloxone is sold over the counter in all 50 states [6]. Our page on opioid overdose signs and symptoms covers the picture in more detail.

Dependence and Withdrawal

People do get stuck on it, and both agencies say so plainly.

The FDA states that some people may have difficulty stopping using tianeptine and may experience withdrawal symptoms, and that the clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal [1]. It also names who is most exposed: people with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine [1].

The CDC’s poison center data gives the reported symptoms. Of 29 withdrawal-associated calls, tianeptine was the only substance involved in 21 [2]. In those 21, the signs reported most often were agitation and nausea, followed by vomiting, tachycardia, hypertension, diarrhea, tremor and sweating [2]. A separate CDC case report says that tianeptine dependence and a withdrawal syndrome of anxiety, sweating, myalgias, chills, and depression have been described [4]. “Have been described” is the source’s own phrasing and it stays.

No federal source publishes a tianeptine withdrawal timeline. This page does not supply one, and it does not borrow the opioid figures either, because those are written for specific opioids rather than for a drug that merely acts on the same receptor. Our page on withdrawal symptoms covers the general picture, and stopping is a conversation to have with a clinician rather than an experiment to run alone.

Treatment: What Exists and What Does Not

Start with what is missing. No medication is approved for tianeptine use disorder, and the published treatment evidence is case reports and poison center records rather than trials. Any page that implies otherwise is selling something.

What exists is still worth a lot. The FDA’s own instruction is to talk to a health care provider, because approved treatments exist for opioid dependence, depression, anxiety and pain [1]. In the CDC series, the therapies clinicians actually gave were fluids, benzodiazepines and oxygen for exposures, and benzodiazepines, fluids and antiemetics for withdrawal calls [2]. That is a description of what happened in an emergency department, not a protocol for anyone to follow.

Because tianeptine is an opioid receptor agonist [2], an assessment usually looks at whether an opioid use disorder is in the picture. Where it is, MedlinePlus describes the medications used, which include methadone, buprenorphine and naltrexone [7]. Our page on medication-assisted treatment explains how that model works.

Two other threads matter here more than on most substance pages. The first is the mood disorder underneath. The FDA says people turn to tianeptine to self-treat anxiety or depression [1], so dual diagnosis treatment is often the right shape of care. The second is what happens after the acute phase. SAMHSA states that detoxification is not substance abuse treatment and rehabilitation [8], and MedlinePlus says most people need long-term treatment after detox [7].

Medical detox is a level of care rather than a course of treatment. Some people step into residential rehab afterwards, and some into an outpatient program. Our explainer on the levels of care sets out what each tier involves, our guide to getting into rehab covers the order the calls happen in, and our treatment centers lists our campuses by state. If cost is the obstacle, see what rehab costs and whether insurance covers it.

Frequently Asked Questions

Sources

1. U.S. Food and Drug Administration. (2025). Tianeptine Products Linked to Serious Harm, Overdoses, Death. Consumer Updates. https://www.fda.gov/consumers/consumer-updates/tianeptine-products-linked-serious-harm-overdoses-death
2. El Zahran, T., Schier, J., Glidden, E., Kieszak, S., Law, R., Bottei, E., Aaron, C., King, A., & Chang, A. (2018). Characteristics of Tianeptine Exposures Reported to the National Poison Data System — United States, 2000–2017. Morbidity and Mortality Weekly Report, 67(30), 815–818. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/67/wr/mm6730a2.htm
3. Counts, C. J., Spadaro, A. V., Cerbini, T. A., Krotulski, A. J., Greller, H. A., Nelson, L. S., Ruck, B. E., & Calello, D. P. (2024). Notes from the Field: Cluster of Severe Illness from Neptune’s Fix Tianeptine Linked to Synthetic Cannabinoids — New Jersey, June–November 2023. Morbidity and Mortality Weekly Report, 73(4), 89–90. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a5.htm
4. Goodnough, R., Li, K., Fouladkou, F., Lynch, K. L., Shah, M., Smollin, C. G., & Blanc, P. D. (2018). Notes from the Field: Toxic Leukoencephalopathy Associated with Tianeptine Misuse — California, 2017. Morbidity and Mortality Weekly Report, 67(27), 769–770. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/67/wr/mm6727a5.htm
5. Centers for Disease Control and Prevention. (2024). What to Do If You Think Someone Is Overdosing. Stop Overdose. https://www.cdc.gov/stop-overdose/response/index.html
6. Centers for Disease Control and Prevention. (2025). Lifesaving Naloxone. Stop Overdose. https://www.cdc.gov/stop-overdose/caring/naloxone.html
7. MedlinePlus Medical Encyclopedia. Opiate and Opioid Withdrawal. National Library of Medicine. https://medlineplus.gov/ency/article/000949.htm
8. Center for Substance Abuse Treatment. (2006). Detoxification and Substance Abuse Treatment, Chapter 1: Overview, Essential Concepts, and Definitions in Detoxification. Treatment Improvement Protocol (TIP) Series No. 45. Substance Abuse and Mental Health Services Administration, via NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK64119/

This page is for general information and is not medical advice. Only a licensed clinician who knows your history can tell you what is right for you. If you or someone you know is in immediate danger, call 911. For free, confidential support 24/7, call or text 988.

Author

Kevin Wandler, MD

Chief Medical Officer, The Recovery Village