Ibuprofen 400mg Tablets

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its analgesic, anti-inflammatory, and antipyretic effects by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling very tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or changes in vision.

Severe Skin Reactions: This medication can cause rare but serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. These conditions can be life-threatening and may affect other organs. Seek immediate medical help if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Common Side Effects

Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects, including:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Dizziness

If you experience any of these side effects or any other symptoms that concern you or do not resolve, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Certain health issues, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weak heart)
+ Recent heart attack
Current use of other NSAIDs, salicylate medications like aspirin, or pemetrexed.
Fertility issues, including difficulty getting pregnant or ongoing fertility evaluations.
* Pregnancy, planned pregnancy, or potential pregnancy. This medication may harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

You should also have your blood pressure checked regularly, as directed by your doctor, since medications like this one can cause high blood pressure. Additionally, discuss your alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks. If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse effects. Furthermore, do not take this medication for longer than your doctor has instructed.

Be aware that this medication may increase your risk of bleeding easily. To avoid injury, be cautious and use a soft toothbrush and an electric razor.

The use of medications like this one can increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor. Additionally, people who have had a recent heart attack and take medications like this one may have a higher risk of heart attack and heart-related death. They may also be more likely to die in the year following the heart attack compared to those not taking this type of medication. Talk to your doctor about these potential risks.

This medication may also increase the risk of a severe brain problem called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe stomach upset, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.

In rare cases, medications like this one can cause liver problems, which can be fatal. If you notice signs of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes, contact your doctor right away.

If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that NSAIDs like this medication may affect ovulation, which can impact fertility. However, this effect is reversible when the medication is stopped. Discuss this with your doctor.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect; increased risk of renal impairment, especially in elderly or volume-depleted patients.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
• Digoxin: May increase serum digoxin levels.

• Sulfonylureas: May enhance hypoglycemic effect.
• Phenytoin: May increase serum phenytoin levels.
• Beta-blockers: Reduced antihypertensive effect.
• Cholestyramine: May reduce ibuprofen absorption (administer ibuprofen 1 hour before or 4-6 hours after cholestyramine).

• Not available

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of kidney problems (decreased urination, swelling in ankles/feet, unusual fatigue)
• Unusual weight gain or swelling (fluid retention)
• Severe skin reactions (rash, blistering, peeling skin)

Use is generally not recommended during pregnancy, especially in the third trimester. Consult a healthcare provider.

Considered compatible with breastfeeding. Ibuprofen is excreted into breast milk in very small amounts, which are generally considered clinically insignificant.

Generally safe and effective for fever and pain in children 6 months and older when dosed appropriately by weight. Not recommended for infants under 6 months without medical supervision. Risk of Reye's syndrome is not associated with ibuprofen (unlike aspirin).

Increased risk of adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and for signs of GI bleeding more closely.

• Always take ibuprofen with food, milk, or a full glass of water to minimize gastrointestinal upset.
• Advise patients to avoid concomitant use of other NSAIDs (including aspirin for pain relief, but not low-dose aspirin for cardiac protection unless advised by a doctor) to prevent additive side effects.
• Educate patients on the signs of GI bleeding and cardiovascular events, and to seek immediate medical attention if they occur.
• For patients on low-dose aspirin for cardiac protection, ibuprofen may interfere with aspirin's antiplatelet effect. Advise taking ibuprofen at least 8 hours before or 30 minutes after immediate-release aspirin.
• Long-term use, especially at high doses, increases the risk of serious adverse effects.

• Acetaminophen (Tylenol) - for pain and fever, but no anti-inflammatory effect.
• Other NSAIDs (e.g., Naproxen, Celecoxib, Diclofenac) - for pain, fever, and inflammation.
• Opioid analgesics (for severe pain, short-term use, with caution)
• Topical analgesics (e.g., Lidocaine patches, topical NSAIDs)
• Non-pharmacological therapies (e.g., RICE method for injuries, physical therapy, heat/cold therapy, massage, acupuncture)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.