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Vyscoxa (Celecoxib): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
10 mg/mL
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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 - Vyscoxa

What is the most important information I should know about VYSCOXA, and medicines called nonsteroidal anti-inflammatory drugs (NSAIDs)?

VYSCOXA may cause serious side effects, including:

  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

    • with increasing doses of NSAIDs
    • with longer use of NSAIDs

Do not take VYSCOXA right before or after a heart surgery called a “coronary artery bypass graft (CABG)".

Avoid taking VYSCOXA after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take VYSCOXA after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:

    • anytime during use
    • without warning symptoms
    • that may cause death

  • The risk of getting an ulcer or bleeding increases with:

    • history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
    • taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “selective serotonin reuptake inhibitors (SSRIs)”, or “serotonin norepinephrine reuptake inhibitors (SNRIs)”
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems

  • VYSCOXA should only be used:

    • exactly as prescribed
    • at the lowest dose possible for your treatment
    • for the shortest time needed

What is VYSCOXA?

VYSCOXA is a prescription medicine used:

  • for management of the signs and symptoms of osteoarthritis in adults
  • for management of the signs and symptoms of rheumatoid arthritis in adults
  • for management of the signs and symptoms of ankylosing spondylitis in adults
  • for management of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in children 2 years of age and older

VYSCOXA is not used for management of the signs and symptoms of short-term pain or treatment of menstrual cramps.

It is not known if VYSCOXA is safe and effective in children with JRA less than 2 years of age, with a body weight less than 22 pounds (10 kg), and with active signs and symptoms.

It is not known if VYSCOXA is safe and effective in children with osteoarthritis or ankylosing spondylitis.

Do not take VYSCOXA:

  • if you are allergic to celecoxib or to any of the ingredients in VYSCOXA. See the end of this Medication Guide for a complete list of ingredients in VYSCOXA.
  • if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs
  • right before or after heart bypass surgery
  • if you have a history of allergic reactions to sulfonamides medicines. Ask your healthcare provider if you are not sure.

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

  • have heart problems
  • have bleeding problems
  • have had ulcers
  • have liver or kidney problems
  • have high blood pressure
  • have asthma

  • are pregnant or plan to become pregnant. Taking VYSCOXA at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take VYSCOXA for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take VYSCOXA after about 30 weeks of pregnancy.

  • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with VYSCOXA.

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

VYSCOXA and some other medicines can interact with each other and cause serious side effects.

Do not start taking any new medicine without talking to your healthcare provider first.

How should I take VYSCOXA?

  • Take VYSCOXA exactly as your healthcare provider tells you to take it.
  • If you take too much VYSCOXA, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What are the possible side effects of VYSCOXA?

VYSCOXA can cause serious side effects, including:

See “What is the most important information I should know about VYSCOXA, and medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

  • liver problems including liver failure
  • new or worse high blood pressure
  • heart failure
  • kidney problems including kidney failure
  • increase in blood potassium level (hyperkalemia)
  • life-threatening allergic reactions
  • asthma attacks in people who have asthma
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • Other side effects of VYSCOXA include stomach pain, constipation, diarrhea, indigestion, nausea, vomiting, dizziness and rash.

Get emergency help right away if you get any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop taking your VYSCOXA and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet

These are not all the possible side effects of VYSCOXA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

How should I store VYSCOXA?

  • Store VYSCOXA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the VYSCOXA bottles tightly closed and away from light. Shake the bottle well before use.
  • Throw (discard) the VYSCOXA bottle away 21 days after opening.

Keep VYSCOXA and all medicines out of the reach of children.

General information about the safe and effective use of VYSCOXA.

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

What are the ingredients in VYSCOXA?

Active ingredient: celecoxib

Inactive ingredients: anhydrous citric acid, glycerin, magnesium aluminometasilicate, methylparaben, propylparaben, purified water, sodium citrate dihydrate, sucralose, and xanthan gum.

Manufactured for and Distributed by: Carwin Pharmaceutical Associates, LLC, Hazlet, NJ 07730

For more information, go to www.carwinpharma.com or call: 844-700-5011

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 211759 · View the label on DailyMed

Revision date stated in the text: July 2025

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 Vyscoxa

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Nonsteroidal Anti-inflammatory Drug
Active ingredient Celecoxib 10 mg/mL
Dosage form Suspension
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) CARWIN PHARM ASSOC
FDA approval NDA 211759New Drug Application (NDA) Approved July 29, 2025
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
10 mg/mL – 473 ml in 1 bottle NDC 15370-501-16

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.