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Emrosi: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
40 mg
Other brand names:
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

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

What is EMROSI?

EMROSI is a prescription medicine used to treat adults with pimples and bumps (inflammatory lesions) caused by a condition called rosacea.

It is not known if EMROSI is:

  • safe and effective for the treatment of infections
  • safe and effective in children under the age of 18 years

Who should not take EMROSI?

Do not take EMROSIif you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

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

  • have diarrhea or watery stools
  • have liver problems
  • have kidney problems
  • have had increased pressure around your brain that may have cause vision problems

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

  • are breastfeeding or plan to breastfeed. EMROSI passes into your milk and may harm your baby. Do not breastfeed during treatment with EMROSI and for 4 days after your final dose

Tell your healthcare provider about all the other medicines you take,including prescription and over-the counter medicines, vitamins and herbal supplements.

EMROSI and other medicines may affect each other and cause serious side effects. EMROSI may affect the way other medicines work, and other medicines may affect how EMROSI works.

Especially tell your healthcare provider if you take:

  • a blood thinner medicine
  • penicillin antibiotic medicine
  • antacids that contain aluminum, calcium, or magnesium or iron-containing medicines
  • an acne medicine that contains isotretinoin

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take EMROSI?

  • Take EMROSI exactly as your healthcare provider tells you

  • Take EMROSI 1 time per day with or without food. Taking EMROSI with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach

  • Swallow EMROSI whole. Do not chew or crush the capsules

If you take too much EMROSI, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking EMROSI?

  • You should not drive or operate dangerous machinery until you know how EMROSI affects you. EMROSI may cause you to feel dizzy or lightheaded or have a spinning feeling (vertigo)
  • Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with EMROSI. EMROSI can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with EMROSI

What are the possible side effects of EMROSI?

EMROSI may cause serious side effects, including:

  • Serious skin and allergic reactionshave happened during treatment with minocycline. EMROSI may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking EMROSI and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including:

    • skin redness, rash, hives, sores in your mouth, or your skin blisters and peels
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble swallowing or breathing
    • blood in your urine
    • fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine
    • pain on the right side of the stomach area (abdominal pain)
    • chest pain or abnormal heartbeats
    • swelling in your legs, ankles, and feet
  • Permanent tooth discoloration and problems with tooth enamel.EMROSI may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. EMROSI may cause tooth enamel to not develop properly. You should not use EMROSI during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. See “Before taking EMROSI, tell your healthcare provider about all your medical conditions, including if you:”
  • Slow bone growth.EMROSI may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with EMROSI.
  • Diarrhea (antibiotic associated colitis).Antibiotic associated colitis can happen with most antibiotics, including EMROSI. This type of diarrhea may be caused by an infection ( Clostridioides difficile) in your intestines and can be severe and lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.

  • Liver problems.EMROSI may cause serious liver problems that can lead to death.Stop taking EMROSI and call your healthcare provider right away if you get any of the following symptoms of liver problems:

    • loss of appetite
    • tiredness
    • diarrhea
    • yellowing of your skin or the whites of your eyes
    • unexplained bleeding or bleeding easily than normal
    • confusion
    • sleepiness
  • Central nervous system effects.See “ What should I avoid while taking EMROSI?” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with EMROSI or if treatment is stopped.
  • Increased pressure around the brain (idiopathic intracranial hypertension).This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking EMROSI and tell your healthcare provider right away if you have unusual headaches, blurred vision, double vision, and vision loss.
  • Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis).Using EMROSI for a long time to treat acne may cause immune system reactions. Stop taking EMROSI and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.
  • Sensitivity to sunlight (photosensitivity).See “ What should I avoid while taking EMROSI?”
  • Discoloration (tissue hyperpigmentation).EMROSI may cause darkening of your nails, bone, skin, eyes, teeth, gums, scars, and internal organs.

The most common side effects of EMROSI includestomach upset or burning (dyspepsia) after eating or drinking.

Your healthcare provider may do blood tests and check you for side effects during treatment with EMROSI and may stop treatment if you develop certain side effects.

These are not all the side effects with EMROSI.

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 Journey Medical Corporation at 1-855-531-1859.

How should I store EMROSI?

  • Store EMROSI at room temperature between 68°F to 77°F (20°C to 25°C)
  • EMROSI comes in a child-resistant package
  • Keep EMROSI container tightly closed
  • Keep EMROSI away from light, moisture, and excessive heat
  • Do not eat desiccant

Keep EMROSI out of the reach of children

General information about the safe and effective use of EMROSI.

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

What are the ingredients in EMROSI?

Active ingredient: minocycline hydrochloride

Inactive ingredients:ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry clear, polyethylene glycol, triethyl citrate, and talc

Manufactured for:

Journey Medical Corporation

Scottsdale, AZ 85258

For more information, go to www.journeymedicalcorp.comor call 1-855-531-1859

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 11/2024

EMR-P02-R01

EMROSI is a trademark of Journey Medical Corporation.

All other trademarks are the properties of their respective owners.

Copyright © 2024, Journey Medical Corporation. All rights reserved.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 219015 · View the label on DailyMed

Revision date stated in the text: November 2024

Found a mistake? Write to us via the contact page.

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

Drug information for Emrosi

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 Minocycline hydrochloride 40 mg
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) JOURNEY
FDA approval NDA 219015New Drug Application (NDA) Approved November 1, 2024
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
40 mg – 30 in 1 bottle NDC 69489-131-30
40 mg – 7 in 1 bottle NDC 69489-131-07

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.