Talk to your healthcare professional if you have questions about care for depression, anxiety or other conditions. The FDA warns physicians about unapproved tianeptine products that are linked to severe adverse events, including dependence, toxicity, and death. The FDA has issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs.
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. Despite that, some companies are distributing and selling unlawful products containing tianeptine to consumers, including products with high doses. They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. 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.
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People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine. FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Consumers who experience a bad reaction to any tianeptine product should seek immediate medical help. Tianeptine is not approved by the FDA for any indication, is not recognized as safe for use in food, and does not qualify as a dietary ingredient under U.S. law. Internationally, it is marketed as an atypical antidepressant with a labeled dose of 12.5 mg orally three times daily. It exhibits mu-opioid receptor agonist activity, and supratherapeutic doses have been linked to euphoria and dependence.
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Last year, Calello and her colleagues published a study documenting a cluster of emergency calls in New Jersey tied to a flavored elixir called Neptune’s Fix. People experienced distress, rapid heartbeat, low blood pressure and seizures after drinking it. More than a dozen of the 20 patients had to be admitted for intensive care. Additionally, the drug cannot legally be added to foods and beverages or sold as a dietary supplement — something the FDA has repeatedly warned U.S. companies about. Tianeptine is approved in a number foreign countries as an antidepressant, usually as a low-dose pill taken three times a day. But it has never been approved by the FDA for any medical condition in the U.S.
Warnings, Alerts, and Press Releases
Some U.S. consumers have ingested tianeptine at doses up to 10,000 mg daily—more than 250 times the typical therapeutic dose used abroad—despite the drug’s unapproved status and life-threatening risks. In the U.S., reports of bad reactions and unwanted effects involving tianeptine are increasing. 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. The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and antianxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma and death. In the U.S., tianeptine is not currently scheduled under the Controlled Substances Act.
- Medical journals and reports to the FDA suggest that bad effects may occur when tianeptine is taken at doses higher than those prescribed in the countries where the drug has been approved.
- Some people take tianeptine with opioids, alcohol or other drugs to heighten the effects.
- Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers.
- These reports describe U.S. consumers taking daily doses between 1.3 and 250 times the daily tianeptine dose typically recommended in products approved in other countries.
- Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately.
Let’s be proactive in understanding and addressing the use of tianeptine products, which are available even to our nation’s youth. Calls to poison control centers increased 525% between 2018 and 2023, according to a data analysis published earlier this year. In about 40% of cases, the person had to seek medical care, with more than half of them needing critical care. Some people may have difficulty stopping using tianeptine and may experience withdrawal symptoms. The clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal, according to the Centers for Disease Control and Prevention.
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Tianeptine is sometimes misused to self-treat withdrawal symptoms from alcohol and other substances. People with a history of substance misuse are at a higher risk of misusing tianeptine. Although tianeptine is not approved in the U.S., it can be bought online and at small stores. Tianeptine may be referred to as “gas station heroin.” In some places it is labeled as a dietary supplement that enhances cognition and stabilizes mood. Tianeptine also may be labeled to help with pain, decrease appetite and increase sexual performance.
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Super Chill Products include cherry, lemon, and chocolate tianeptine products linked to harm vanilla flavors. Still, under-the-radar firms sell tianeptine in various formulas, often with brand names like Zaza, Tianaa, Pegasus and TD Red. Although that is technically illegal, the FDA does not preapprove ingredients added to supplements and beverages.
When taken in small doses, tianeptine may help with symptoms of anxiety, depression and irritable bowel syndrome. When taken at higher doses, tianeptine can cause a high or a feeling of euphoria. While tianeptine is not an opioid, the drug binds to some of the same receptors in the brain, which can temporarily produce effects akin to oxycodone and other opioids. Tianeptine also carries some of the same physiological risks of opioids, including the potential to dangerously depress breathing. Tianeptine is not included in the federal Controlled Substances Act, which bans or restricts drugs that have no medical use or have a high potential for abuse, such as heroin, LSD and PCP. But about a dozen states have passed laws prohibiting or restricting tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee.
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Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. Medical journals and reports to the FDA suggest that bad effects may occur when tianeptine is taken at doses higher than those prescribed in the countries where the drug has been approved. These reports describe U.S. consumers taking daily doses between 1.3 and 250 times the daily tianeptine dose typically recommended in products approved in other countries.
Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers. FDA recommends that health care professionals encourage patients to avoid all products containing tianeptine, including those claiming to treat an ailment or disorder. While tianeptine may help treat depression, anxiety and irritable bowel syndrome, the risks often outweigh the benefits. Tianeptine is usually sold as a dietary supplement that can help with energy, mood, pain, sexual performance and appetite control.
- 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.
- People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine.
- We also have issued import alerts to help detain tianeptine shipments at our borders.
- One explanation for the rise in calls is simply that more Americans are using the products.
- Until recently, Alabama had the highest rate of tianeptine-related calls in the southern U.S., which increased more than 1,400% between 2018 to 2021.
In some cases, those laws have led to more cases of withdrawal among users of tianeptine, which can be chemically addictive. But state data also shows some success in reducing harm tied to the drug. One explanation for the rise in calls is simply that more Americans are using the products. Experts aren’t sure but national figures show a big rise in emergency calls involving the drug. Send a note of thanks to Mayo Clinic researchers who are revolutionizing healthcare and improving patient outcomes.