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Seysara: Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Seysara

What is SEYSARA?

  • SEYSARA is a prescription medicine used to treat moderate to severe acne vulgaris in people 9 years and older.
  • SEYSARA should not be used for the treatment or prevention of infections

It is not known if SEYSARA is safe and effective for use for longer than 12 weeks.

It is not known if SEYSARA is safe and effective in children under 9 years of age.

Do not take SEYSARA:

  • if you are allergic to medicines in the tetracycline-class. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

What should I tell my healthcare provider before taking SEYSARA?

Before taking SEYSARA, tell your healthcare provider about all of your medical conditions, including if you:

  • have diarrhea or watery stools
  • have vision problems

  • are pregnant or plan to become pregnant. SEYSARA may harm your unborn baby. Taking SEYSARA during the second and third trimesters of pregnancy may cause serious side effects on the growth of bone and teeth of your baby. Stop taking SEYSARA and call your healthcare provider right away if you become pregnant during your treatment with SEYSARA.

  • are breastfeeding or plan to breastfeed. SEYSARA can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SEYSARA. You should not breastfeed during treatment with SEYSARA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEYSARA and other medicines can affect each other causing serious side effects.

Especially tell your healthcare provider if you take:

  • a blood thinner
  • a penicillin antibiotic medicine
  • antacids that contain aluminum, calcium or magnesium or iron-containing products
  • an acne medication taken by mouth that contains isotretinoin or acitretin

How should I take SEYSARA?

  • Take SEYSARA exactly as your healthcare provider tells you.

  • Skipping doses or not taking all doses of SEYSARA may:

    • make the treatment not work as well.
    • increase the chance that the bacteria will become resistant to SEYSARA.

  • Take SEYSARA 1 time a day with or without food.

  • Take SEYSARA with enough fluid to completely swallow the tablet and to lower your risk of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • If you take too much SEYSARA, stop taking SEYSARA and call your healthcare provider right away or go to the nearest hospital emergency room.

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).

What are the possible side effects of SEYSARA?

SEYSARA may cause serious side effects, including:

  • Harm to an unborn baby. See “What should I tell my healthcare provider before taking SEYSARA?”
  • Permanent teeth discoloration. SEYSARA may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use SEYSARA during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth to 8 years of age.
  • Slow bone growth. SEYSARA may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with SEYSARA.
  • Diarrhea. Diarrhea can happen with most antibiotics, including SEYSARA. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools.
  • Central nervous system effects. See “What should I avoid while taking SEYSARA?” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with SEYSARA or if treatment is stopped. Call your healthcare provider if these symptoms do not go away.
  • Increased pressure around the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You may be more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop taking SEYSARA and tell your healthcare provider right away if you have blurred vision, vision loss, or headaches.
  • Sensitivity to sunlight (photosensitivity). See “What should I avoid during treatment with SEYSARA?”

The most common side effect of SEYSARA is nausea.

SEYSARA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of SEYSARA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Almirall at 1-866-665-2782.

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.

General information about the safe and effective use of SEYSARA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SEYSARA for a condition for which it was not prescribed. Do not give SEYSARA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about SEYSARA that is written for health professionals.

What are the ingredients in SEYSARA?

Active ingredient: sarecycline hydrochloride

Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titanium dioxide.

© 2019 Almirall, LLC. All rights reserved. ALMIRALL

ALMIRALL

SEYSARA® is a registered trademark of Almirall, LLC.

Almirall® and its design are trademarks of Almirall, LLC.

Distributed by Almirall, LLC

Malvern, PA 19355, USA

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 209521 · View the label on DailyMed

Revision date stated in the text: July 2019

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Seysara

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Tetracycline-class Drug
Active ingredient Sarecycline hydrochloride
Dosage form Tablet, coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) ALMIRALL
FDA approval NDA 209521New Drug Application (NDA) Approved October 1, 2018
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
60 mg – 30 in 1 bottle NDC 16110-245-30
100 mg – 30 in 1 bottle NDC 16110-246-30
150 mg – 30 in 1 bottle NDC 16110-247-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.