Naproxen

Common Uses

Naproxen is primarily used to treat pain and inflammation. Over-the-counter versions are typically used for short-term relief of minor aches and pains, while prescription-strength versions are used for more severe or chronic conditions.

Pain and Fever Relief

Naproxen is effective for managing several types of everyday pain, including:

• Headaches and migraines
• Muscle aches and backaches
• Dental pain
• Menstrual cramps
• Pain from the common cold
• Fever reduction

Inflammatory Conditions

Because it reduces inflammation, naproxen is frequently prescribed for long-term management of joint and soft tissue conditions, such as:

• Arthritis: This includes osteoarthritis, rheumatoid arthritis, and juvenile arthritis.
• Ankylosing spondylitis: A type of arthritis that affects the spine.
• Gout: It is used to treat the sudden, intense pain and swelling of acute gout attacks.
• Tendonitis and Bursitis: It helps relieve inflammation in the tendons or the fluid-filled sacs that cushion the joints.

Mechanism of Action

Naproxen works by inhibiting the activity of enzymes called cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). These enzymes are responsible for the production of prostaglandins, which are hormone-like chemicals that the body releases in response to injury or illness.

Prostaglandins play a central role in how the body experiences certain symptoms:

• Pain: They sensitize nerve endings, making them more responsive to pain signals.
• Inflammation: They cause blood vessels to widen, leading to redness and swelling in affected tissues.
• Fever: They act on the area of the brain that regulates body temperature.

By reducing the overall levels of prostaglandins, naproxen helps to decrease swelling, lower a fever, and alleviate various types of pain. Because it targets the chemical processes that lead to inflammation, it is frequently used for conditions involving joint or muscle discomfort.

Common Side Effects

Some side effects of naproxen are common and may go away as your body adjusts to the medication. These include:

• Constipation, gas, or stomach pain
• Headache, dizziness, or drowsiness
• Lightheadedness or a spinning sensation
• Ringing in the ears or hearing changes
• Excessive thirst
• Difficulty falling asleep or staying asleep
• Burning or tingling sensations in the arms or legs

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Allergic reactions: Skin rash, hives, itching, or swelling of the face, lips, tongue, or throat.
• Breathing issues: Shortness of breath, difficulty breathing, or wheezing.
• Vision changes: Blurred vision or other changes in eyesight.
• Fluid retention: Unexplained weight gain or swelling in the abdomen, feet, ankles, or lower legs.
• Liver or kidney problems: Yellowing of the skin or eyes (jaundice), dark urine, pain in the upper right stomach, or changes in urination.
• Flu-like symptoms: Fever, chills, sore throat, or extreme fatigue.
• Skin issues: Blistering, peeling, or purple spots under the skin.
• Heart symptoms: Fast heartbeat or chest pain.

Serious Cardiovascular Risks

Nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen, increase the risk of serious cardiovascular thrombotic events, such as heart attack and stroke, which can be fatal. This risk may occur early in treatment and may increase with longer duration of use.

Naproxen is contraindicated for the treatment of pain before or after coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risks

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines. These conditions can occur at any time during use without warning symptoms and may be fatal.

Factors that increase the risk of GI bleeding include:

• A history of stomach ulcers or GI bleeding.
• Longer duration of NSAID therapy.
• Concurrent use of oral corticosteroids, aspirin, or anticoagulants.
• Older age or poor health status.
• Consumption of alcohol while taking the medication.

Pregnancy Warnings

Use of naproxen at 20 weeks of pregnancy or later may cause rare but serious kidney problems in the unborn baby, leading to low amniotic fluid. It is generally recommended to avoid naproxen starting at 30 weeks of pregnancy because it may cause premature closure of a heart vessel in the fetus.

Other Precautions

Severe Allergic and Skin Reactions

Naproxen can cause serious allergic reactions (anaphylaxis) and serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. These conditions can be life-threatening and may occur without warning.

Kidney and Liver Function

Long-term use of NSAIDs can result in kidney injury. Naproxen is not recommended for individuals with advanced kidney disease. Additionally, elevations in liver enzymes may occur, and rare, severe liver reactions have been reported.

Fluid Retention

Naproxen may cause fluid retention and edema. It should be used with caution in individuals with heart failure or high blood pressure.

Pregnancy

Using naproxen during pregnancy can cause serious complications for the developing fetus. Healthcare providers generally advise against using this medication starting at 20 weeks of pregnancy because it may cause:

• Kidney problems in the unborn baby.
• Low levels of amniotic fluid (oligohydramnios).
• Heart problems, such as the premature closure of a vital blood vessel called the ductus arteriosus, if taken at 30 weeks or later.

Naproxen may also delay or prolong labor and delivery. If you are pregnant or planning to become pregnant, it is important to discuss pain management options with a healthcare professional.

Fertility

Nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen may temporarily interfere with ovulation. This can make it more difficult for some individuals to conceive while using the medication. These effects are usually reversible once the medication is stopped.

Breastfeeding

Naproxen passes into breast milk. Because of the potential for adverse effects on a nursing infant, its use is generally not recommended while breastfeeding. Consult a healthcare provider to determine if naproxen is appropriate for your situation or if an alternative treatment is safer.

Oral Tablet Forms

Naproxen is most commonly available in various tablet formulations designed to release the medication at different rates:

• Immediate-release tablets: These are standard tablets that release the medication into the system shortly after ingestion.
• Delayed-release tablets: These tablets often feature an enteric coating, which is designed to prevent the medication from dissolving in the stomach so it can be released in the small intestine instead.
• Extended-release tablets: These formulations are designed to release the medication slowly over a longer period, which may allow for less frequent dosing.

Capsules and Liquids

For those who prefer alternatives to standard tablets, naproxen is also available in the following forms:

• Capsules: This includes liquid-filled capsules and softgels.
• Oral suspension: This is a liquid form of the medication, which is often used for patients who have difficulty swallowing solid pills.

FDA Approval and Indications

Naproxen was first approved by the FDA in 1976. It is indicated for the management of pain, primary dysmenorrhea (menstrual cramps), and various inflammatory conditions, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute gout.

Boxed Warnings

The FDA requires a boxed warning for all prescription nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen, highlighting two major risks:

• Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (heart attack), and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Safety Communications

In 2015, the FDA strengthened existing warnings that non-aspirin NSAIDs increase the chance of a heart attack or stroke. The agency noted that these risks can occur within the first few weeks of using an NSAID and the risk may increase the longer the medicine is taken. The FDA also clarified that while the risk is present for all NSAIDs, it is unclear if the risk of a specific NSAID is higher or lower than another.

Regulatory Classification

Naproxen is available in several forms. Lower-strength formulations (such as naproxen sodium 220 mg) are available over-the-counter for temporary relief of minor aches and pains. Higher strengths and delayed-release formulations require a prescription.

Stomach and Intestinal Risks

Naproxen belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Using alcohol while taking NSAIDs can irritate the lining of the stomach and digestive tract. This combination increases the likelihood of developing ulcers or experiencing gastrointestinal bleeding.

Daily Alcohol Consumption

The risk of internal bleeding is particularly high for individuals who consume three or more alcoholic drinks every day while using naproxen. This complication can occur at any time during treatment and may happen without warning symptoms.

Symptoms to Watch For

It is important to monitor for signs of a serious gastrointestinal interaction. Seek medical attention immediately if you experience:

• Black, bloody, or tarry stools
• Coughing up blood or vomit that looks like coffee grounds
• Severe or persistent stomach pain