Sarecycline
Sarecycline is a tetracycline-class antibiotic used to treat inflammatory acne lesions in people 9 and older with moderate to severe non-nodular acne vulgaris.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sarecycline (Seysara) is a tetracycline-class antibiotic for the inflamed pimples of moderate to severe non-nodular acne in people 9 and older, working by stopping acne bacteria from making the proteins they need to grow; on the market since about 2018, it is a newer, less familiar option than doxycycline or minocycline. Most people tolerate it well, and nausea is what they notice most, with vaginal yeast infections less common. Watch for headache with blurred vision or vision changes, which can signal raised pressure around the brain, and report severe or lasting diarrhea, even weeks after finishing. Avoid it in pregnancy and breastfeeding, and protect your skin from the sun.
Clinical pearls
- Swallow it with plenty of water, with or without food, to protect your esophagus from irritation and ulcers.
- Antacids, iron products and bismuth subsalicylate (Pepto-Bismol) can block its absorption, so take them at a different time.
- Do not combine it with isotretinoin or acitretin, because both can raise pressure around the brain.
- If you take a blood thinner or digoxin, tell that prescriber you started sarecycline so doses or levels can be checked.
Patient information guide A plain-language walkthrough of Sarecycline, written from its FDA label.
What Sarecycline is used for
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Sarecycline is an antibiotic used for acne.
- Seysara tablets treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years and older.
- It has not been evaluated for treating infections.
- Effectiveness beyond 12 weeks and safety beyond 12 months are not established.
How Sarecycline works
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Sarecycline is an aminomethylcycline, a type of tetracycline antibiotic. In lab studies, it binds to part of the bacterial ribosome (the cell's protein-making machinery) in P. acnes. This blocks protein production and stops bacterial growth.
How this relates to acne improvement is not known. Lab studies showed a low tendency for resistance to develop in P. acnes.
Sarecycline dosage
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Seysara is a tablet taken by mouth once daily, with or without food. The tablet strength is chosen by body weight. Drink plenty of fluid with it to protect your esophagus. Follow your prescriber's and the label's directions.
Dosing details from the FDA-approved label
From the Sarecycline prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Patients who weigh 33 to 54 kg
- 60 mg tablet once daily, with or without food
- Administer with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration; if no improvement after 12 weeks, reassess treatment
- Patients who weigh 55 to 84 kg
- 100 mg tablet once daily, with or without food
- Administer with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration; if no improvement after 12 weeks, reassess treatment
- Patients who weigh 85 to 136 kg
- 150 mg tablet once daily, with or without food
- Administer with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration; if no improvement after 12 weeks, reassess treatment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dosage of SEYSARA is based on body weight described in Table 1 . If there is no improvement after 12 weeks, reassess treatment with SEYSARA. Table 1: Dosing Table for SEYSARA Body Weight (kg) Tablet Strength 33 to 54 kg 60 mg tablet 55 to 84 kg 100 mg tablet 85 to 136 kg 150 mg tablet Take SEYSARA once daily, with or without food. To reduce the risk of esophageal irritation and ulceration, administer SEYSARA with adequate amounts of fluid. The recommended dosage of SEYSARA is once daily with or without food ( 2 ): 60 mg for patients who weigh 33-54 kg, 100 mg for patients who weigh 55-84 kg, 150 mg for patients who weigh 85-136 kg.
Read the full Dosage and Administration section on DailyMed →
Sarecycline side effects
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In clinical trials, the most common side effect was nausea.
Common side effects
- Nausea
- Vaginal yeast infections (less common, in females)
- Vaginal yeast infections in under 1% of females
When to get medical help
- Severe or lasting diarrhea, which could be antibiotic-associated colitis. This can happen even weeks to months after treatment.
- Headache, blurred vision or other vision changes, which could signal increased pressure around the brain (intracranial hypertension)
- Dizziness, light-headedness or vertigo, especially before driving or using machinery
- Severe sunburn after sun or tanning bed exposure
- New fungal or other overgrowth infections (superinfection)
- If you become pregnant while taking it, tell your doctor right away
Sarecycline warnings and precautions
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- Pregnancy and teeth: can harm a fetus and permanently discolor developing teeth.
- Intracranial hypertension: headache, blurred vision and swelling of the optic nerve; vision loss can be permanent.
- Diarrhea: antibiotic-associated colitis can range from mild to fatal and may occur months later.
- Sun sensitivity: exaggerated sunburn; avoid tanning beds and UV treatment, and wear protective clothing.
- Dizziness: use caution driving or using machinery.
- Overgrowth and resistance: fungal overgrowth and drug-resistant bacteria can occur.
Sarecycline interactions
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Several medicines can interact with sarecycline.
- Oral retinoids (isotretinoin, acitretin): both can raise brain pressure; avoid.
- Antacids, bismuth subsalicylate and iron: reduce absorption; separate doses.
- Penicillin: may interfere with its killing action; avoid.
- Anticoagulants: bleeding risk may rise; dose may need to be lowered.
- Digoxin and other P-gp substrates: levels may rise; monitoring needed.
Interactions listed in the FDA-approved label
From the Sarecycline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Oral retinoids (including isotretinoin and acitretin): Tetracyclines may cause increased intracranial pressure as do oral retinoids. Avoid coadministration of SEYSARA with oral retinoids.
- Antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations: Coadministration may impair absorption of SEYSARA, similar to other tetracyclines, which may decrease its efficacy. Separate dosing of SEYSARA from these products.
- Penicillin: SEYSARA may interfere with the bactericidal action of penicillin, similar to other tetracyclines. Avoid coadministration of SEYSARA with penicillin.
- Anticoagulants: SEYSARA may depress plasma prothrombin activity, which may increase the risk of bleeding in patients on anticoagulant therapy, similar to other tetracyclines. Decrease anticoagulant dosage when coadministered with SEYSARA as appropriate.
- P-glycoprotein (P-gp) substrates (e.g. digoxin): Concomitant use of SEYSARA may increase concentrations of concomitantly administered P-gp substrates. Monitor for toxicities of drugs that are P-gp substrates and may require dosage reduction when given concurrently with SEYSARA.
- Oral hormonal contraceptives (ethinyl estradiol and norethindrone acetate): There is no clinically significant effect of SEYSARA on the efficacy of oral contraceptives containing ethinyl estradiol and norethindrone acetate.
Read the label’s full interactions text
7 DRUG INTERACTIONS Oral retinoids: avoid coadministration. ( 5.4 , 7.1 ) Antacids and iron preparations: separate dosing of SEYSARA. ( 7.1 ) Penicillin: avoid coadministration. ( 7.2 ) Anticoagulants: decrease anticoagulant dosage as appropriate. ( 7.2 ) P-glycoprotein substrates: monitor for toxicities of drugs that may require dosage reduction. ( 7.2 ) 7.1 Effect of Other 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 )] . Avoid coadministration of SEYSARA with oral retinoids. 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. Separate dosing of SEYSARA from antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations. 7.2 Effect of SEYSARA on Other Drugs Penicillin Similar to other tetracyclines, SEYSARA may interfere with the bactericidal action of penicillin. Avoid coadministration of SEYSARA with penicillin. Anticoagulants Similar to other tetracyclines, SEYSARA may depress plasma prothrombin activity, which may increase the risk of bleeding in patients who are on anticoagulant therapy. Decrease anticoagulant dosage when coadministered with SEYSARA as appropriate. P-Glycoprotein (P-gp) Substrates Concomitant use of SEYSARA may increase concentrations of concomitantly administered P-gp substrates (e.g. digoxin). Monitor for toxicities of drugs that are P-gp substrates and may require dosage reduction when given concurrently with SEYSARA [see Clinical Pharmacology ( 12.3 )] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sarecycline
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- Do not use if allergic to any tetracycline.
- Avoid during pregnancy; stop if you become pregnant.
- Breastfeeding is not recommended.
- Not recommended under age 8; not established under age 9.
- Men trying to conceive should avoid it.
- Tell your doctor about vision problems.
- Not enough data in people 65 and older.
- Effects in end-stage kidney disease or severe liver impairment are not known.
Sarecycline overdose
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If too much is taken, stop the medicine and get medical help. Treatment is symptom-based and supportive. Dialysis would not help.
What Sarecycline does in the body
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How sarecycline affects acne in the body is unknown. At about 3 times the maximum recommended dose, it did not prolong the QT interval (a heart rhythm measure) to a clinically relevant degree.
How your body processes Sarecycline
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Sarecycline reaches peak blood levels about 1.5 to 2 hours after a dose. A high-fat meal with milk lowered absorption somewhat. Steady levels are reached by about day 7, and the half-life is about 21 to 22 hours.
Little is broken down by the liver. It leaves the body in both stool and urine. Age, weight, sex, kidney impairment and mild to moderate liver impairment made no clinically significant difference.
How to store Sarecycline
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Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) . Protect from moisture and excessive heat.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Sarecycline
17 supplements and herbal products have documented interactions with Sarecycline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Sarecycline: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sarecycline — the kind of thing our pharmacy team would talk through with you at the counter.
What is Seysara for?
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How should I take it?
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What side effects should I expect?
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Do I need to worry about the sun?
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What should I avoid taking with it?
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Is it safe in pregnancy?
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Is Sarecycline available over the counter?
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When was Sarecycline first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sarecycline on HelloPharmacist
Sarecycline forms and strengths (how it comes)
Sarecycline is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sarecycline inactive ingredients by manufacturer.
Tablet
How this form is used
- Seysara is used for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years and older.
- Seysara is taken once daily, with or without food.
- Seysara tablet strength is chosen by body weight.
- Take Seysara with adequate fluid to lower the risk of esophageal irritation and ulcers.
- Seysara should be reassessed if there is no improvement after 12 weeks.
Sarecycline on the U.S. market: products, makers and brands
How Sarecycline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Sarecycline product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Seysara; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Sarecycline products
A representative set of FDA-listed product records for Sarecycline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 60 mg | Oral | Almirall, LLC | NDA | View NDC → |
| 100 mg | Oral | Almirall, LLC | NDA | View NDC → |
| 150 mg | Oral | Almirall, LLC | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Sarecycline NDCs →
Sarecycline side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sarecycline — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sarecycline in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sarecycline FDA approval history
How Sarecycline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sarecycline recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sarecycline recalls since July 2021.
✅No Sarecycline recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2059018 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2059022In current FDA listings
Look up RxCUI 2059018 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sarecycline supply and shortage status
Whether Sarecycline is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sarecycline brand names
Sarecycline is sold under one brand name in the FDA directory — Seysara. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sarecycline: manufacturers and labelers
One company lists Sarecycline products with the FDA. By number of product records, the largest are Almirall, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sarecycline drug class (RxNorm)
Sarecycline belongs to the Tetracycline-class Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sarecycline page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Almirall, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →