ADDYI
As listed in the register: ADDYI
100 mg · tablet
- Prescription only
- Urinary and reproductive system, hormones
- Active substance
- Flibanserin
- Made by
- Sprout Pharmaceuticals Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (ADDYI). It describes the substance, not this exact product.
The mechanism of action of ADDYI in the treatment of women less than 65 years of age with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty (not due a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance) is not known.
Flibanserin is primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19.
Effect of Food Food increased the extent of absorption and slowed the rate of absorption of a 50 mg dose of flibanserin (one half the recommended dosage).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-22
Safety of the active substance
From the US prescribing label for the same active substance (ADDYI). It describes the substance, not this exact product.
WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ].
- ADDYI is contraindicated in patients:.
- Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2) ]..
- With hepatic impairment [see Boxed Warning and Warnings and Precautions (5.5) ]..
- With known hypersensitivity to ADDYI or any of its components.
Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Details
| Made by | Sprout Pharmaceuticals Inc |
|---|---|
| Active substance | Flibanserin |
| Used in | Urinary and reproductive system, hormones |
| Strength | 100 mg |
| Form | tablet |
| Classification | G02CX02 · Urinary and reproductive system, hormones |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02473550 |
| DPD drug code | 96294 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.