Tianeptine Products Linked to Serious Harm, Overdoses, Death

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People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine products, which have been associated with serious health risks and even death.

Tianeptine, a drug, is not approved by the U.S. Food and Drug Administration for any medical use. 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.

Although the FDA has warned consumers about tianeptine, vendors continue to market and sell tianeptine for medical uses. The FDA is aware that tianeptine has been sold online – in pill, liquid and  powder forms.

Tianeptine Isn’t FDA Approved for Any Medical Use

Tianeptine is not approved as a drug in the U.S. Although other countries have approved tianeptine to treat depression and anxiety, some have restricted how tianeptine is prescribed or dispensed, or warned of possible addiction.

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.

Tianeptine Has Safety Risks and Can Be Abused

Cases described in medical journals, in calls to U.S. poison control centers and in reports to the FDA suggest that tianeptine has a potential for abuse. People with a history of opioid use disorder or dependence may be at particular risk of abusing tianeptine.

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.

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.

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.

The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive. In addition, tianeptine is not a dietary ingredient.

The FDA has issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs. We also have issued import alerts to help detain tianeptine shipments at our borders.

How to Protect Yourself and Your Family

Consumers should avoid all products containing tianeptine, including those claiming to treat an ailment or disorder. Talk to your health care provider if you need help with opioid dependence, depression, anxiety, pain, or other ailments. There are approved treatments for those and related conditions. 
Help is available to treat opioid or other substance use disorders. Find state-licensed providers who specialize in treating substance use disorders and addiction at www.findtreatment.gov. Or call 1-800-662-HELP (4357).

The FDA will continue to take regulatory action to address the importation, distribution and sale of unlawful tianeptine products. In the meantime, you can report an adverse event involving tianeptine by using the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form sent to you in the mail, then complete and return to the address on the form, or submit it by fax to 1-800-FDA-0178.

If you have a question about a medication, call your pharmacist or the FDA. The FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email at druginfo@fda.hhs.gov, and by phone, at 1-855-543-DRUG (3784) and 301-796-3400.

Call the poison help line at 1-800-222-1222 if you suspect poisoning from tianeptine.