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.
The Food and Drug Administration (FDA) has issued an alert regarding the increased availability and use of products containing tianeptine, an unapproved substance associated with serious adverse events, including death. Commonly referred to as “gas station heroin,” tianeptine is being sold as a dietary supplement, nootropic, or research chemical in gas stations, convenience stores, vape shops, and online platforms under brand names such as Tianaa, Zaza, Neptune’s Fix, Pegasus, and TD Red.
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. In the U.S., reported ingestion has ranged from 50 mg to 10,000 mg daily.
Adverse events associated with tianeptine include agitation, tachycardia, nausea, vomiting, respiratory depression, confusion, drowsiness, coma, and death. Withdrawal symptoms that resemble opioid discontinuation (e.g., myalgias, diaphoresis, craving) have been documented. Tianeptine may not be detected on routine drug screens.
A 2024 cluster of severe illnesses in New Jersey linked to Neptune’s Fix—found to contain both tianeptine and synthetic cannabinoids—highlighted the potential for compounded toxicity. Events included QT prolongation, hypotension, seizures, and death.
The FDA has issued consumer warnings, sent enforcement letters, and placed related products on import alert. Clinicians are advised to counsel patients to avoid products that contain tianeptine and consider evidence-based therapies for mood, anxiety, pain, or substance use disorders. For suspected tianeptine-related adverse events, clinicians should contact Poison Control (1-800-222-1222) and report as many product details as available to the FDA MedWatch system.
Source: FDA