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FDA Approves OTC Celebrex for Pain Relief

Written byReviewed byLast Updated on: 05/20/2025()by|Published on April 22nd, 2025

Celebrex is a prescription medicine used to treat arthritis pain. Celebrex is a prescription medicine, and it is prescribed for people who do not respond to other nonsteroidal anti-inflammatory drugs (NSAIDs) that have the same active ingredient as Celebrex.

Celebrex, known by the brand name Celebrex, belongs to a class of drugs called nonselective NSAIDs, and it is used to treat pain, swelling, and stiffness in conditions like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. The drug is also used to treat pain and fever due to ankylosing spondylitis, and also to reduce the symptoms of osteoarthritis.

Celebrex is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking the production of prostaglandins, which are chemicals in the body that cause inflammation. When prostaglandins are released, they cause pain and swelling in the body, and the body may respond by increasing the body’s sensitivity to pain.

It is important to note that Celebrex should only be used under the guidance and supervision of a health care professional, and there is a need for safety data, including that of the manufacturer, to ensure that the medicine is safe for use. The safety data of Celebrex is not well established, and it is not recommended for use in children.

Common Side Effects of Celebrex

The common side effects of Celebrex include:

  • swelling of the face, lips, tongue, or throat
  • reduced appetite or weight loss
  • headache

Some individuals may also experience gastrointestinal discomfort or indigestion while taking Celebrex.

It is important to note that Celebrex is not a cure for arthritis pain and is not used to treat other types of pain. Celebrex can cause a range of side effects, and some people may experience some side effects.

If you experience any of these side effects, speak with your doctor or healthcare professional. If you have any questions about Celebrex, speak with your doctor or healthcare professional.

Serious Side Effects of Celebrex

If you experience any serious side effects, such as severe stomach pain, allergic reaction, or difficulty breathing, seek medical attention immediately.

If you have any symptoms of an allergic reaction, such as swelling of your lips, tongue, or face, seek medical help right away.

If you experience any severe side effects, such as chest pain, severe stomach pain, difficulty breathing, or signs of a serious allergic reaction, seek medical help right away.

How Celebrex Can Be Taken

Celebrex is available as an oral capsule, and it can be taken either alone or with food.

Oral capsule is usually taken once a day, but it is important to take it consistently at the same time every day. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose.

Celebrex is available in tablet form and is usually taken once a day. It may be taken with or without food.

For more information on Celebrex, please see the label on your medicine.

Take Celebrex exactly as it was prescribed for you. Do not take your medicine in different doses or for the same number of times. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets. Swallow the medicine in a large glass of water before swallowing it. If you are not sure what to do, talk to your doctor or pharmacist.

If you miss a dose, take it as soon as you remember, and then continue your regular dosing schedule. If it is almost time for your next dose, skip the missed dose and continue your usual dosing schedule.

Celebrex 100mg Tablet contains the active ingredient Celecoxib. It belongs to the family known as non-steroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors. It is used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. In conditions like rheumatoid arthritis and osteoarthritis, excess production of prostaglandins by your body can lead to pain and inflammation. Celebrex 100mg Tablet works by decreasing the production of prostaglandins, effectively reducing pain and inflammation.

Do not take Celebrex 100mg Tablet if you are allergic to Celebrex 100mg Tablet or any of its ingredients. Inform your doctor if you had reactions to sulfonamide medicines, suffer from ulcers or bleeding in the stomach or intestines, or experienced adverse reactions to NSAID medications like aspirin.

Before starting the treatment, inform your doctor because it is recommended to not take this medicine if you are pregnant or are breastfeeding. Do not take this medicine if you have severe liver or kidney disease, have inflammatory intestinal conditions, or have heart-related issues such as heart failure, heart disease, or circulation problems. Additionally, if you have had surgeries on leg arteries or have a history of blood circulation problems, this medicine usage should be avoided. Celebrex 100mg Tablet contains lactose. If you are sugar intolerant, consult your doctor before using this product. This medicine is for adults only, it is not for use in children.

Inform your doctor about if you have a history of stomach or intestinal ulcers or bleeding (avoid if currently present), are on acetylsalicylic acid or antiplatelet therapies, use blood clotting or corticosteroid medications, or simultaneously use other non-acetylsalicylic NSAIDs like ibuprofen.

Report your doctor if you have conditions such as smoking, diabetes, high blood pressure, high cholesterol, compromised heart, liver, or kidney function, fluid retention, dehydration, past severe allergic reactions to medications, ongoing infections, or are over 65 years old. Monitoring may be necessary. Notably, Celebrex 100mg Tablet could mask fever or infection signs. Remember, alcohol combined with NSAIDs may increase gastrointestinal risks.

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Celebrex is a selective COX-2 inhibitor for the treatment of acute and chronic pain syndromes. It reduces inflammation, pain, and fever by inhibiting the Cox-2 isoform. The clinical experience of Celebrex is that it has a low risk of serious adverse cardiovascular events such as myocardial infarction, stroke, or ventricular arrhythmia.

Situational Benefits

Celebrex has been extensively studied and evaluated for the treatment of acute, moderate, and chronic pain for over a decade. It has been demonstrated that Celebrex is effective at reducing the pain associated with the following conditions:

  • Headache
  • Muscular Pain
  • Dental Pain
  • Dyspepsia (Dysminor periodontal disease)

In a double-blind, placebo-controlled clinical trial, 22 patients (18-30 years of age) with chronic, moderate-to-severe pain were randomized to Celebrex (200 mg/d) or placebo for 4 weeks. At week 4, patients taking Celebrex reported significantly more relief from the following primary and secondary outcomes:

  • Pain control (pain reduction)
  • Pain intensity
  • Tenderness and swelling
  • Fever (with a mean decrease of 38% at week 4).

Patients with osteoarthritis and rheumatoid arthritis were also randomized. Celebrex significantly improved the primary and secondary outcomes, with the decrease in pain intensity at week 4 being significantly better than placebo. The mean change in pain intensity was greater with Celebrex than with placebo. Celebrex significantly reduced fever, tenderness, and swelling, as well as pain control, tenderness, and swelling.

Overall, Celebrex was well tolerated. However, the increased risk of cardiovascular events was noted with respect to celecoxib. Celebrex is not recommended for patients with a body mass index (BMI) greater than 30 kg/m2.

Who Should Not Use Celebrex?

There are no contraindications for the use of celecoxib in patients with a BMI greater than 30 kg/m2. In addition, patients with kidney problems, anemia, and an elevated creatinine kinase (CK) should not take celecoxib.

Alternatives to Celebrex

For patients with severe pain associated with acute and chronic pain, celecoxib may be considered. However, the benefits of celecoxib over other nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors in the treatment of pain and inflammation have not been well established. Non-selective NSAIDs such as ibuprofen have been used for decades to treat acute and chronic pain, including primary and chronic musculoskeletal pain. NSAIDs are the most common class of anti-inflammatory drugs, and they are also the preferred choice for patients with chronic musculoskeletal pain (e.g., osteoarthritis or rheumatoid arthritis). However, they can cause side effects such as gastrointestinal disturbances, heartburn, and rash, and they can also cause renal dysfunction. Therefore, celecoxib should not be used in patients with severe pain with acute or chronic musculoskeletal pain. NSAIDs should be used with caution in patients with renal impairment because they can cause severe kidney impairment.

For patients with renal impairment, it is recommended that patients who are unable to metabolize their renal metabolites should not take celecoxib. In addition, patients with severe renal impairment should avoid taking celecoxib because it can increase the risk of bleeding, ulceration, and other serious adverse effects. Patients who have severe renal insufficiency should not take celecoxib. Patients with a history of bleeding or blood clotting disorders should not take celecoxib.

For patients with moderate to severe acute pain, a non-selective NSAID such as ibuprofen or naproxen can be used. However, the benefits of NSAIDs in the treatment of pain and inflammation have not been well established. NSAIDs can cause renal dysfunction in patients with mild to moderate renal impairment and can increase the risk of bleeding, ulceration, and other serious adverse effects. Therefore, patients with renal impairment should avoid taking celecoxib.

For patients with severe acute pain, a non-selective NSAID such as aspirin or ibuprofen can be used.

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WASHINGTON, Nov. 30, 2013 /PRNewswire-FirstCall via COMTEX News Network/ -- The Drug Enforcement Administration is advising consumers not to purchase or use Celebrex, a prescription medicine sold under the brand name Celebrex, and other similar products.

The FDA on Tuesday announced that it has received reports of children suffering from severe headaches, toothache, and arthritis from taking the prescription medicine.

The FDA said the drug is being used to treat a variety of conditions, including but not limited to pain associated with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The FDA also said that it has received information about the possibility of children experiencing toothaches from taking the drug.

The FDA said that it has determined that the safety and effectiveness of Celebrex in children has not been confirmed.

The FDA also said that a pediatric study involving more than 3,000 children, ages 6 and older, has shown that Celebrex can lead to the development of certain types of arthritis in children. The drug is being sold under the brand name Celecoxib under the brand name Celebrex.

The FDA said that it has determined that the safety and effectiveness of the drug has not been confirmed.

The FDA said that the information regarding the potential for children experiencing toothaches from taking the drug has not been made public.

The FDA said that the FDA has determined that the safety and effectiveness of the drug has not been confirmed.

The FDA said that the FDA has determined that the information regarding the potential for children experiencing toothaches from taking the drug has not been made public.