Prescription medicine
Sarecycline Brand names: Seysara
Sarecycline (Seysara) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sarecycline FDA label on DailyMed (effective June 5, 2024, Almirall, LLC); the NDA 209521 record on Drugs@FDA; every sarecycline label on DailyMed.
Highlights of the record
FDA label of June 5, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Forms and strengths
- 60 mg
- 100 mg
- 150 mg
Coated tablet.
On the market
- Earliest approval on file
- October 1, 2018 Seysara, Almirall; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 9, 2033 Seysara tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 191 through July 30, 2026
What is sarecycline used for?
From the label: indications and usageSEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )]. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )]. […]
FDA pharmacologic class: Tetracycline-class Drug.
Source: FDA drug label (Seysara), Almirall, LLC, effective June 5, 2024 (SPL set b200957c-3004-4988-be97-9fd619a83649), via openFDA; the full label on DailyMed
What does the patient leaflet for sarecycline say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid during treatment with SEYSARA?Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop taking SEYSARA if you get sunburn. You should not drive or operate dangerous machinery until you know how SEYSARA affects you. Tetracyclines may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).
From the patient leaflet: How should I store SEYSARA?Store SEYSARA at room temperature between 68°F to 77°F (20°C to 25°C). Keep SEYSARA away from moisture and excessive heat. Keep SEYSARA and all medicines out of the reach of children.
Source: FDA drug label (Seysara), Almirall, LLC, effective June 5, 2024 (SPL set b200957c-3004-4988-be97-9fd619a83649), via openFDA; the full label on DailyMed
Is there a generic for sarecycline (Seysara)?
No generic sarecycline is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Seysara tablets: the compound patent runs to February 9, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sarecycline label say about other medicines?
The sarecycline label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acitretin | drug interactions | Drugs on SEYSARA Oral Retinoids Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin [see Warnings and Precautions ( 5.4 )]. |
| Bismuth subsalicylate | drug interactions | Antacids and Iron Preparations Coadministration with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations may impair absorption of SEYSARA, similar to other tetracyclines, which may decrease its efficacy. |
| Digoxin | drug interactions | P-Glycoprotein (P-gp) Substrates Concomitant use of SEYSARA may increase concentrations of concomitantly administered P-gp substrates (e.g. digoxin). |
| Isotretinoin | drug interactions | Drugs on SEYSARA Oral Retinoids Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin [see Warnings and Precautions ( 5.4 )]. |
| Norethindrone | drug interactions | Oral Hormonal Contraceptives There is no clinically significant effect of SEYSARA on the efficacy of oral contraceptives containing ethinyl estradiol and norethindrone acetate [see Clinical Pharmacology ( 12.3 )]. |
| Tetracycline | warnings and precautions | … Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. |
Source: FDA drug label (Seysara), Almirall, LLC, effective June 5, 2024 (SPL set b200957c-3004-4988-be97-9fd619a83649), via openFDA; the full label on DailyMed
What do FAERS reports show for sarecycline?
The FDA Adverse Event Reporting System holds 191 reports that list sarecycline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other tetracyclines
- the pharmacologic class, with prices and generics
- Sarecycline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other