Ibuprofen 800mg Tablets

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through the reversible inhibition of 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 immediately or seek emergency medical attention:

Allergic reactions: 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, fainting, numbness or tingling, or shortness of breath.
High blood pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological symptoms: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness: Feeling very tired or weak.
Other severe symptoms: Ringing in the ears, severe back pain, or changes in vision.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:

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, or swollen glands

Other Side Effects

Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, contact your doctor. 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 conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weakened heart)
+ Recent heart attack
Current use of other NSAIDs, salicylate medications like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluations, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or potential pregnancy. This medication can 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. They will help determine the safety of taking this medication with your other 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.

There is a risk of developing high blood pressure while taking this medication. Your doctor will likely advise you to have your blood pressure checked regularly. Additionally, it is crucial to discuss your alcohol consumption with your doctor before drinking. If you smoke, you should also talk to your doctor about the potential risks.

If you have asthma, you may be more sensitive to this medication, so it is vital to consult with your doctor. 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.

This medication may affect your blood's ability to clot, making you more prone to bleeding. To reduce the risk of injury, be cautious and use a soft toothbrush and an electric razor.

The use of this medication has been associated with an increased risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. It is essential to discuss these risks with your doctor. Additionally, people who have had a recent heart attack may be at a higher risk of heart attack and heart-related death when taking this medication. Your doctor can provide more information about these risks.

There is also a risk of developing a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.

In rare cases, this medication has been linked to liver problems, which can be life-threatening. If you notice any signs of liver problems, such as dark urine, fatigue, loss of appetite, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes, seek medical attention promptly.

If you are 60 years or older, you may be more susceptible to side effects from this medication. Your doctor can help you weigh the benefits and risks.

Women of childbearing age should be aware that this medication, like other NSAIDs, may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. If you are trying to conceive, discuss this with your doctor.

If you are breastfeeding, it is essential to consult with your doctor about the potential risks to your baby. Your doctor can help you make an informed decision about taking this medication while breastfeeding.

• Aspirin (high-dose, for antiplatelet effect, due to interference)
• Other NSAIDs (increased risk of GI and renal adverse effects)
• Ketorolac (concurrent use)

• Anticoagulants (e.g., Warfarin, Heparin, DOACs) - increased risk of bleeding
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low-dose) - increased risk of bleeding
• Corticosteroids - increased risk of GI ulceration/bleeding
• Diuretics (e.g., Furosemide, Hydrochlorothiazide) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs - reduced antihypertensive effects, increased risk of renal impairment and hyperkalemia
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased risk of nephrotoxicity
• Tacrolimus - increased risk of nephrotoxicity
• SSRIs/SNRIs - increased risk of GI bleeding

• Digoxin - increased digoxin levels
• Phenytoin - increased phenytoin levels
• Sulfonylureas - increased hypoglycemic effect
• Quinolone antibiotics - increased risk of seizures
• Alcohol - increased risk of GI irritation/bleeding

• Not readily categorized as minor for significant clinical impact; most interactions are moderate to major.

• Gastrointestinal symptoms (e.g., abdominal pain, dyspepsia, nausea, vomiting, heartburn)
• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground emesis; severe abdominal pain)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Changes in blood pressure
• Unusual bruising or bleeding

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn. Use during the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus, and only under strict medical supervision.

Ibuprofen is excreted in breast milk in very small amounts. It is generally considered compatible with breastfeeding when used at usual analgesic doses, as adverse effects in breastfed infants are unlikely. However, caution is advised, especially with high doses or prolonged use.

Ibuprofen 800mg tablets are generally not recommended for pediatric patients due to the high dose. Lower strengths (e.g., 50mg/1.25mL suspension, 100mg chewable tablets, 200mg tablets) are used for fever and pain in children based on weight and age. Use in infants under 6 months is generally not recommended without medical advice.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, 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 closely.

• Always advise patients to take ibuprofen with food or milk to minimize GI upset, even though it may slightly delay absorption.
• Emphasize the importance of staying hydrated, especially in patients at risk for renal impairment.
• Counsel patients on the signs and symptoms of GI bleeding and cardiovascular events, and when to seek immediate medical attention.
• Remind patients that ibuprofen is not a substitute for low-dose aspirin for cardiovascular protection; in fact, it can interfere with aspirin's antiplatelet effect if taken concurrently.
• For chronic use, consider co-prescribing a proton pump inhibitor (PPI) or H2 blocker for GI protection, especially in high-risk patients.
• Be mindful of the cumulative dose of NSAIDs if patients are taking multiple OTC products containing ibuprofen or other NSAIDs.

• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Other NSAIDs (e.g., Naproxen, Celecoxib, Diclofenac) - chosen based on patient factors, duration of action, and specific COX selectivity.
• Opioid analgesics (for severe pain, short-term use, with significant side effect profile)
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, massage, acupuncture, heat/cold therapy, exercise)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.