What is the information on the Ibuprofen (Non-Steroidal Anti-Inflammatory Drug (NSAID)) leaflet?

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Last updated: March 31, 2025View editorial policy

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From the Guidelines

Ibuprofen should be taken at a dose of 400-800 mg every six hours, with a maximal initial dose of 800 mg and a maximal daily dosage of 2.4 g, to minimize the risk of gastrointestinal complications and other adverse effects, as recommended by recent guidelines 1.

Important Considerations

When taking ibuprofen, it is essential to be aware of the potential risks and benefits. The medication can cause stomach upset, heartburn, and dizziness, and more serious but rare side effects include stomach bleeding, kidney problems, and increased risk of heart attack or stroke with prolonged use 1.

Contraindications and Interactions

Ibuprofen should be avoided by those with certain conditions, including aspirin allergy, advanced kidney disease, heart failure, or during the last trimester of pregnancy 1. It may interact with blood thinners, certain blood pressure medications, and other NSAIDs, so it is crucial to consult a healthcare provider if taking other medications 1.

Mechanism of Action

Ibuprofen works by blocking enzymes called cyclooxygenases that produce prostaglandins, chemicals involved in inflammation and pain signaling, which explains its effectiveness in reducing pain and inflammation 1.

Gastrointestinal Risks

The use of ibuprofen can increase the risk of gastrointestinal complications, including dyspepsia, abdominal pain, and GI bleeding, especially when combined with other medications such as aspirin or anticoagulants 1.

Prevention of GI Complications

To minimize the risk of GI complications, it is recommended to take ibuprofen with food or milk, and to use the lowest effective dose for the shortest duration necessary 1. Additionally, patients at high risk of GI complications may benefit from gastroprotective therapy, such as proton pump inhibitors or misoprostol 1.

From the FDA Drug Label

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Ibuprofen (eye" bue proe' fen) Tablets, USP What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can 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 NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG). ” Avoid taking NSAIDs 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 NSAIDs 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: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed

The key information about ibuprofen from the leaflet includes:

  • Serious side effects: Increased risk of heart attack, stroke, bleeding, ulcers, and tears in the esophagus, stomach, and intestines.
  • Contraindications: Do not take NSAIDs if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs, or right before or after heart bypass surgery.
  • Precautions: Tell your healthcare provider about all of your medical conditions, including liver or kidney problems, high blood pressure, asthma, and pregnancy or breastfeeding.
  • Interactions: NSAIDs can interact with other medicines, including prescription or over-the-counter medicines, vitamins, or herbal supplements.
  • Side effects: NSAIDs can cause serious side effects, including new or worse high blood pressure, heart failure, liver problems, kidney problems, low red blood cells, life-threatening skin reactions, and life-threatening allergic reactions 2.

From the Research

Ibuprofen Leaflet Information

  • Ibuprofen is a widely used oral over-the-counter (OTC) analgesic for treating pain, including acute and chronic pain conditions 3.
  • The efficacy of ibuprofen has been compared to other analgesics, such as paracetamol (acetaminophen), in various studies. One overview review found that ibuprofen was consistently superior to paracetamol at conventional doses in a range of painful conditions, including acute post-operative pain, dysmenorrhoea, and osteoarthritis 4.
  • Ibuprofen can be used in combination with other analgesics, such as acetaminophen and aspirin, to achieve additive or synergistic pain relief with minimal adverse consequences 5.
  • The safety and efficacy of ibuprofen have been evaluated in various studies, including a pooled analysis of five studies that compared the efficacy and safety of OTC doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea 6.
  • Ibuprofen has also been studied in combination with selective serotonin reuptake inhibitors (SSRIs) for the treatment of depression, with some studies suggesting that concomitant use of ibuprofen and SSRIs may be associated with reduced risk of psychiatric contacts 7.

Key Findings

  • Ibuprofen is generally considered safe and effective for treating pain, but inappropriate use can lead to injury 3.
  • Ibuprofen is usually superior to paracetamol in producing pain relief in various painful conditions 4.
  • Combination analgesics, including ibuprofen, can be effective for pain management, but patient-specific cautions are necessary to minimize adverse consequences 5.
  • Ibuprofen has been shown to be effective in relieving pain and symptoms of primary dysmenorrhea, with a good safety profile 6.
  • Concomitant use of ibuprofen and SSRIs may be associated with reduced risk of psychiatric contacts, but further research is needed to fully understand the effects of this combination 7.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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