Chemical formula: C₂₁H₂₅ClN₂O₄S Molecular mass: 436.952 g/mol PubChem compound: 68870
In a peri- and postnatal study, increased post-implantation and postnatal losses were observed in rats at a maternotoxic dose. There are no or limited data (less than 300 pregnancy outcomes) from the use of tianeptine in pregnant women.
Therefore, it is preferable not to use tianeptine during pregnancy whatever the term.
It is preferable to maintain a balanced maternal psychic equilibrium throughout pregnancy. If tianeptine is necessary to ensure this balance, treatment should be initiated or continued at the necessary dose throughout pregnancy and if possible as monotherapy and the pharmacological profile of the molecule should be taken into account when monitoring the newborn baby.
Dysgalactia in the dams was observed in rats at a maternotoxic dose. Tricyclic antidepressants are excreted into breast milk, and thus breast feeding is not recommended during treatment.
In rats, a fertility study showed decreased reproductive performances (increase in pre-implantation losses) at a maternotoxic dose.
In humans, no clinical data are available.
Some patients may experience diminished alertness. The attention of drivers and machine-operators should thus be drawn to the risk of somnolence with this product.
Side effects reported with tianeptine in clinical trials are of mild intensity. They consist mainly in nausea, constipation, abdominal pain, somnolence, headaches, dry mouth and dizziness.
The following adverse reactions have been reported during clinical trials and/or post marketing use with tianeptine and are ranked using the following frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
| System Organ Class | Frequency | Preferred Term |
|---|---|---|
| Metabolism and nutrition disorders | Common | Anorexia |
| Not known* | Hyponatremia | |
| Psychiatric disorders | Common | Nightmare |
| Uncommon | Drug abuse and dependence, in particular in subjects less than 50 years old with a history of alcohol or drug dependence | |
| Not known* | Cases of suicidal thought or behaviour have been reported during treatment with tianeptine or shortly after discontinuation Confusional state, hallucination | |
| Nervous system disorders | Common | Insomnia Somnolence Dizziness Headache Lipothymia Tremor |
| Not known* | Extrapyramidal disorder Dyskinesia | |
| Cardiac disorders | Common | Tachycardia Extrasystoles Chest pain |
| Vascular disorders | Common | Hot flush |
| Respiratory disorders | Common | Dyspnoea |
| Gastrointestinal disorders | Common | Gastralgia Abdominal pain Dry mouth Nausea Vomiting Constipation Flatulence |
| Skin disorders | Uncommon | Maculopapular or erythematous rash Pruritus Urticaria |
| Not known* | Acne Dermatitis bullous in exceptional cases | |
| Musculoskeletal disorders | Common | Myalgia Lumbar pain |
| General disorders | Common | Asthenia Lump feeling in throat |
| Hepato-biliary disorders | Not known* | Increased liver enzymes Hepatitis that can, in exceptional cases, be severe |
* Post-marketing experience
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