Excedrin Migraine

Migraine Treatment

Excedrin Migraine is primarily used for the temporary relief of pain caused by migraine headaches. It is designed to treat the headache and help individuals return to their normal activities.

Associated Symptoms

This medication is also used to manage other symptoms that often occur during a migraine attack, including:

• Nausea
• Sensitivity to light
• Sensitivity to sound

The combination of ingredients is intended to address the specific type of pain and functional impairment associated with migraines in adults.

How the Ingredients Work Together

This medication combines three different components that work in unique ways to address migraine symptoms:

• Acetaminophen is a pain reliever and fever reducer. It is thought to work by elevating the body's overall pain threshold, which helps the brain process pain signals differently.
• Aspirin is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking the production of prostaglandins, which are chemicals in the body that cause inflammation and trigger pain signals.
• Caffeine acts as an adjuvant, which means it helps the aspirin and acetaminophen work more effectively. It also helps narrow blood vessels in the brain that may be dilated during a migraine, potentially reducing the throbbing sensation.

By combining these ingredients, the medication addresses both the chemical signals of pain and the physical inflammation associated with migraine headaches.

Common Side Effects

Some people may experience mild side effects while taking this medication. These often relate to the caffeine or aspirin content and may include:

• Nervousness or jitteriness
• Difficulty sleeping (insomnia)
• Upset stomach or heartburn
• Dizziness
• Rapid heartbeat

Serious Side Effects

Stop using the medication and contact a healthcare provider immediately if you notice any of the following serious symptoms:

• Signs of stomach bleeding: Feeling faint, vomiting blood, or passing bloody, black, or tarry stools.
• Severe skin reactions: Reddening of the skin, rash, blisters, or skin peeling. These reactions can occur even if you have taken the medication before without issues.
• Allergic reactions: Hives, swelling of the face or throat, wheezing, or difficulty breathing.
• Liver problems: Yellowing of the eyes or skin (jaundice), dark urine, or persistent pain in the upper right side of the stomach.
• Hearing changes: Ringing in the ears or a sudden loss of hearing.

If you experience symptoms of a stroke or heart attack, such as chest pain, slurred speech, or weakness on one side of the body, seek emergency medical help right away.

Reye's Syndrome

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this medication. If changes in behavior with nausea and vomiting occur, a healthcare provider should be consulted immediately, as these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if:

• More than the recommended dose is taken in a 24-hour period.
• It is taken with other drugs containing acetaminophen.
• Three or more alcoholic drinks are consumed every day while using this product.

Stomach Bleeding Warning

This product contains aspirin, a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The risk is higher for individuals who:

• Are age 60 or older.
• Have had stomach ulcers or bleeding problems.
• Take a blood thinning or steroid drug.
• Take other drugs containing prescription or nonprescription NSAIDs, such as ibuprofen or naproxen.
• Have three or more alcoholic drinks every day while using this product.

Allergy and Skin Reactions

Aspirin may cause a severe allergic reaction, which may include hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may cause rare but serious skin reactions. If a skin rash, reddening, or blister occurs, use should be stopped immediately.

Caffeine Sensitivity

The recommended dose of this medicine contains about as much caffeine as a cup of coffee. Limiting the use of other caffeine-containing medications, foods, or drinks while taking this product is advised, as too much caffeine may cause nervousness, irritability, sleeplessness, and rapid heartbeat.

Pregnancy and Breastfeeding

Aspirin should not be used during the last three months of pregnancy unless directed by a doctor, as it may cause problems in the unborn child or complications during delivery. Those who are pregnant or breastfeeding should consult a healthcare professional before use.

Pregnancy

Excedrin Migraine contains aspirin, which is a nonsteroidal anti-inflammatory drug (NSAID). Using NSAIDs at 20 weeks or later in pregnancy can cause serious kidney problems in an unborn baby, which may lead to low levels of amniotic fluid. It is especially important to avoid using aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may cause bleeding problems or other complications for both the person giving birth and the baby during delivery.

Breastfeeding

The ingredients in Excedrin Migraine, including aspirin and caffeine, can pass into breast milk. Aspirin is generally not recommended for use while breastfeeding due to potential risks to the infant, such as Reye's syndrome. Caffeine may also cause irritability or sleep disturbances in a nursing baby. Healthcare providers typically recommend discussing the risks and benefits of this medication before using it while breastfeeding.

Available Forms

Excedrin Migraine is provided as an oral medication in two primary forms:

• Film-coated tablets: Round, solid oral units.
• Film-coated caplets: Capsule-shaped solid oral units designed for easier swallowing.

Strengths

Each tablet or caplet contains a fixed-dose combination of three active ingredients:

• Acetaminophen
• Aspirin (an NSAID)
• Caffeine

FDA Approval and Indications

Excedrin Migraine was approved by the FDA in 1998 as the first over-the-counter (OTC) medication for the treatment of migraine symptoms. It is indicated for the temporary relief of mild to moderate pain associated with migraine headaches, including sensitivity to light and sound and nausea.

Regulatory Warnings

As an OTC product containing acetaminophen and aspirin, Excedrin Migraine must comply with FDA labeling requirements for internal analgesic products. These include:

• Liver Warning: A warning regarding severe liver damage if more than the recommended dose is taken or if used with alcohol.
• Stomach Bleeding Warning: A warning regarding the risk of stomach bleeding associated with aspirin, particularly in individuals over age 60 or those with a history of stomach ulcers.
• Serious Skin Reactions: The FDA has issued safety communications warning that acetaminophen may cause rare but serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

There are currently no Risk Evaluation and Mitigation Strategies (REMS) or boxed warnings specifically assigned to this combination product beyond the standard OTC labeling requirements.

Caffeine Withdrawal

Excedrin Migraine contains caffeine as an active ingredient. If you use this medication daily or frequently and then suddenly stop, you may experience caffeine withdrawal symptoms. These symptoms typically include:

• Severe headaches
• Fatigue or drowsiness
• Irritability
• Difficulty concentrating
• Nausea

Medication Overuse Headache

Frequent use of combination pain relievers like Excedrin Migraine can lead to a condition known as medication overuse headache, or rebound headache. This occurs when the medication is used more than 10 days per month. When the medication wears off, the headache returns, often more severely, which can lead to a cycle of increased drug use. Stopping the medication to break this cycle may cause a temporary increase in headache frequency and intensity.

Managing Withdrawal

To reduce the risk of withdrawal symptoms and rebound headaches, it is generally recommended to limit the use of Excedrin Migraine to no more than two days per week. If you have been using the medication frequently, consult a healthcare provider for guidance on how to safely reduce your intake. They may suggest a gradual tapering of the dose rather than stopping abruptly to minimize discomfort.