Ibuprofen
Generic name: ibuprofen · Brand names: Advil, Motrin, Motrin IB, Midol
Quick facts
Drug class
Section
DESCRIPTION
Source
DailyMed Granules label; MedlinePlus: 'Ibuprofen is in a class of medications called NSAIDs.'
Source text (exact source wording)
Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration.
Forms and strengths
Section
HOW SUPPLIED
Source text (exact source wording)
Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg (white to off-white, oval, 'I 6' debossing on one side and plain on the other side) 600 mg (white to off-white, caplet, 'I 7' debossing on one side and plain on the other side) 800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side)
Generic available
Value
The chosen label is a generic ibuprofen label from Granules India Limited (marketing category not shown in the text read)
Source
DailyMed Granules label
Common use one line
Used for arthritis symptoms, mild to moderate pain and menstrual pain (Rx label).
What it is used for
Ibuprofen tablets relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis, relieve mild to moderate pain, and treat primary dysmenorrhea (painful periods).
Section
INDICATIONS AND USAGE
Source text (exact source wording)
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
How it works
Ibuprofen relieves pain and lowers fever. How it works is not completely understood, but it may be related to blocking prostaglandin synthetase.
Section
CLINICAL PHARMACOLOGY
Source text (exact source wording)
Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.
Dosage: adults
The label says not to exceed 3,200 mg total daily dose. For arthritis the suggested dosage is 1,200 mg to 3,200 mg daily. For mild to moderate pain it is 400 mg every 4 to 6 hours as necessary. For painful periods it is 400 mg every 4 hours as necessary. If you get stomach complaints, take it with meals or milk.
Section
DOSAGE AND ADMINISTRATION
Source text (exact source wording)
Do not exceed 3,200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1,200 mg to 3,200 mg daily (300 mg four times a day, 400 mg, 600 mg or 800 mg three times a day or four times a day). Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
Dosage: children
Safety and effectiveness of these ibuprofen tablets in children have not been established.
Section
Pediatric Use; INDICATIONS AND USAGE
Source text (exact source wording)
Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Dosage adjustments
Kidney
Treatment is not recommended in advanced kidney disease. If it must be started, kidney function should be closely monitored.
Section
WARNINGS, Advanced Renal Disease
Source text (exact source wording)
No information is available from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease. Therefore, treatment with ibuprofen tablets is not recommended in these patients with advanced renal disease. If ibuprofen tablet therapy must be initiated, close monitoring of the patients renal function is advisable.
Elderly
Use caution in people 65 years and older.
Section
Geriatric Use
Source text (exact source wording)
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
Missed dose
MedlinePlus says to take a missed dose when you remember unless it is almost time for the next one, and not to double up.
Medlineplus source text (exact source wording)
If you are taking ibuprofen on a regular basis, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In an acute overdose, doctors may empty the stomach and give supportive care and oral activated charcoal. Call poison control at 1-800-222-1222.
MedlinePlus lists extreme tiredness, drowsiness, stomach pain, nausea, vomiting, slow or difficult breathing, dizziness, uncontrolled fast eye movements and a blue color around the lips, mouth and nose.
Section
OVERDOSAGE
Source text (exact source wording)
In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.
Medlineplus source text (exact source wording)
Symptoms of overdosage may include: extreme tiredness drowsiness stomach pain nausea vomiting slow or difficult breathing dizziness fast eye movements that you cannot control blue color around the lips, mouth, and nose
Storage
Store at 20º to 25ºC (68º to 77ºF). Avoid excessive heat above 40ºC (104ºF). This is Granules-specific wording.
Section
HOW SUPPLIED
Source text (exact source wording)
Store at 20º to 25ºC (68º to 77ºF). [see USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF).
Medlineplus source text (exact source wording)
Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Boxed warning
NSAIDs raise the risk of serious heart and blood vessel clotting events, including heart attack and stroke, which can be fatal. This risk may occur early and may increase with duration of use. Ibuprofen must not be used around coronary artery bypass graft (CABG) surgery. NSAIDs also raise the risk of serious stomach and intestine bleeding, ulcers and holes, which can be fatal and can happen without warning. Older patients are at greater risk.
Section
BOXED WARNING
Source text (exact source wording)
Cardiovascular Thrombotic Events: Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS) . Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS) . Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal 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. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
Contraindications
Do not use if you are known to be allergic to ibuprofen.
Section
CONTRAINDICATIONS
Source text (exact source wording)
Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen.
Do not use if aspirin or other NSAIDs have caused asthma, hives or allergic-type reactions.
Section
CONTRAINDICATIONS
Source text (exact source wording)
Ibuprofen tablets should not be given to patients who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients
Do not use in the setting of coronary artery bypass graft (CABG) surgery.
Section
CONTRAINDICATIONS
Source text (exact source wording)
Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Warnings and precautions
Use the lowest effective dose for the shortest time. Avoid use right after a heart attack unless benefits outweigh the risk.
Heading
Cardiovascular Thrombotic Events
Source text (exact source wording)
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Avoid the use of Ibuprofen Tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.
NSAIDs can cause new high blood pressure or make it worse.
Heading
Hypertension
Source text (exact source wording)
NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.
Avoid in severe heart failure unless benefits outweigh the risk.
Heading
Heart Failure and Edema
Source text (exact source wording)
Avoid the use of Ibuprofen Tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
Ibuprofen can cause serious stomach and intestine bleeding, ulcers and holes, with or without warning symptoms.
Heading
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
Source text (exact source wording)
NSAIDs, including ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Long-term NSAID use has caused kidney injury.
Heading
Renal Effects
Source text (exact source wording)
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Seek emergency help if a severe allergic-type reaction occurs.
Heading
Anaphylactoid Reactions
Source text (exact source wording)
Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Serious skin reactions can be fatal. Stop ibuprofen at the first appearance of a skin rash or other sign of allergy.
Heading
Serious Skin Reactions
Source text (exact source wording)
NSAIDs, including ibuprofen, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of ibuprofen tablets at the first appearance of skin rash or any other sign of hypersensitivity.
A reaction called DRESS has been reported. It usually shows with fever, rash, swollen lymph nodes and/or facial swelling.
Heading
DRESS
Source text (exact source wording)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as ibuprofen tablets. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling.
Avoid at about 30 weeks of pregnancy and later because of the risk of premature closure of a baby's ductus arteriosus.
Heading
Fetal Toxicity
Source text (exact source wording)
Avoid use of NSAIDs, including ibuprofen tablets, in pregnant women at about 30 weeks gestation and later. NSAIDs including ibuprofen tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Liver tests may rise in up to 15% of patients taking NSAIDs.
Heading
Hepatic effects
Source text (exact source wording)
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including ibuprofen tablets.
Anemia is sometimes seen with NSAIDs.
Heading
Hematological effects
Source text (exact source wording)
Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen tablets.
Rarely, aseptic meningitis with fever and coma has occurred.
Heading
Aseptic Meningitis
Source text (exact source wording)
Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy.
Pregnancy and breastfeeding
Limit dose and length of use between about 20 and 30 weeks of pregnancy and avoid use at about 30 weeks and later. It is not known whether ibuprofen passes into breast milk, so a decision should be made about stopping nursing or the drug.
Section
PRECAUTIONS, Pregnancy; Nursing Mothers
Source text (exact source wording)
Because of these risks, limit dose and duration of ibuprofen tablets use between about 20 and 30 weeks of gestation, and avoid ibuprofen tablets use at about 30 weeks of gestation and later in pregnancy [ see WARNINGS; Fetal Toxicity]. [Pregnancy, Risk Summary] It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. [Nursing Mothers]
Side effects
Common
The most frequent type of side effect is stomach and gut related, reported by 4% to 16% of patients in controlled trials. Nausea, epigastric pain, heartburn, dizziness and rash each occurred in 3% to 9% of patients. Other reactions above 1% include diarrhea, indigestion, constipation, bloating, headache, nervousness, itching, ringing in the ears, decreased appetite, edema and fluid retention.
Threshold
Label: reactions at an incidence greater than 1% in controlled trials (those marked * occur in 3% to 9% of patients). Label does not give a single 'most common' percentage list other than the GI range.
Section
ADVERSE REACTIONS
Source text (exact source wording)
The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. Incidence Greater than 1% (but less than 3%), Probable Causal Relationship: GASTROINTESTINAL Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gl tract (bloating and flatulence). CENTRAL NERVOUS SYSTEM Dizziness*, headache, nervousness. DERMATOLOGIC Rash*, (including maculopapular type), pruritus. SPECIAL SENSES Tinnitus. METABOLIC/ENDOCRINE Decreased appetite. CARDIOVASCULAR Edema, fluid retention. MISCELLANEOUS (see label). * Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked).
Less common
Reactions occurring less frequently than 1 in 100 include stomach or duodenal ulcer with bleeding, gastrointestinal bleeding, gastritis, hepatitis, jaundice, depression, insomnia, confusion, hives, hair loss and hearing loss.
Section
ADVERSE REACTIONS
Source text (exact source wording)
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. [Examples listed in the label table, Probable Causal Relationship, incidence unknown but less than 1%:] Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis. Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma. Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia. Hearing loss, amblyopia.
Serious
Serious reactions include heart attack, stroke, stomach or intestine bleeding, and serious skin reactions. MedlinePlus says to call your doctor right away for unexplained weight gain, trouble breathing, swelling, fever with rash, blisters or peeling skin, hives, swelling of the face or throat, yellowing of the skin or eyes, bloody urine, vision changes, or headache with stiff neck and fever.
Label source text (exact source wording)
Postmarketing Experience - Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE). [see also Boxed Warning and WARNINGS]
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ibuprofen until you speak to your doctor. unexplained weight gain shortness of breath or difficulty breathing swelling of the abdomen, feet, ankles, or lower legs diarrhea fever, rash, blisters, or peeling skin itching hives swelling of the eyes, face, throat, arms, or hands difficulty breathing or swallowing hoarseness excessive tiredness pain in the upper right part of the stomach nausea loss of appetite yellowing of the skin or eyes flu-like symptoms pale skin fast heartbeat cloudy, discolored, or bloody urine back pain difficult or painful urination blurred vision, changes in color vision, or other vision problems headache, stiff neck, fever
Interactions
Drugs
NSAIDs may weaken the blood-pressure effect of ACE inhibitors.
Name
ACE inhibitors
Section
DRUG INTERACTION
Source text (exact source wording)
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Ibuprofen can interfere with the antiplatelet effect of low-dose aspirin. Taking both together is not generally recommended.
Name
Aspirin
Section
DRUG INTERACTION
Source text (exact source wording)
Pharmacodynamic studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric coated low-dose aspirin. concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Ibuprofen can reduce the effect of furosemide and thiazide diuretics in some patients.
Name
Diuretics
Section
DRUG INTERACTION
Source text (exact source wording)
Clinical studies, as well as postmarketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients.
Ibuprofen raised lithium levels in a study, so watch for signs of lithium toxicity.
Name
Lithium
Section
DRUG INTERACTION
Source text (exact source wording)
Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Use caution with methotrexate because NSAIDs may enhance its toxicity.
Name
Methotrexate
Section
DRUG INTERACTION
Source text (exact source wording)
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Using warfarin and an NSAID together carries a higher risk of serious GI bleeding than either alone.
Name
Warfarin-type anticoagulants
Section
DRUG INTERACTION
Source text (exact source wording)
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Cimetidine or ranitidine had no substantive effect on ibuprofen levels.
Name
H-2 antagonists
Section
DRUG INTERACTION
Source text (exact source wording)
In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
Food and alcohol
If you get stomach complaints, take ibuprofen with meals or milk.
Name
Food or milk
Section
DOSAGE AND ADMINISTRATION; CLINICAL PHARMACOLOGY
Source text (exact source wording)
If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. When ibuprofen tablets are administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption.
Use of alcohol is one of the factors that raise the risk of stomach bleeding with NSAIDs.
Name
Alcohol
Section
WARNINGS, Gastrointestinal
Source text (exact source wording)
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.
Patient tips
Read the NSAID Medication Guide. Watch for chest pain, shortness of breath, weakness or slurred speech and report them right away. Stop ibuprofen and call your provider if you get any rash or fever. MedlinePlus says to swallow the tablet whole and that it may be taken with food or milk to prevent stomach upset.
Label section
PRECAUTIONS, Information for Patients
Source
MedlinePlus https://medlineplus.gov/druginfo/meds/a682159.html
Label source text (exact source wording)
Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately. Advise patients to stop taking ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.
Medlineplus source text (exact source wording)
Swallow the tablet whole; do not chew or crush it. Ibuprofen may be taken with food or milk to prevent stomach upset.
Alternatives
Class
nonsteroidal anti-inflammatory drug (NSAID)
Class source
DailyMed Granules label DESCRIPTION; MedlinePlus: 'Ibuprofen is in a class of medications called NSAIDs.'
Note
No recommendation made.
Frequently asked questions
Question
What is ibuprofen used for?
Answer
The Rx tablets relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis, mild to moderate pain, and primary dysmenorrhea.
Source section
INDICATIONS AND USAGE
Source
DailyMed Granules Rx label
Question
Should I take ibuprofen with food?
Answer
If gastrointestinal complaints occur, take ibuprofen tablets with meals or milk.
Source section
DOSAGE AND ADMINISTRATION
Source
DailyMed Granules Rx label
Question
What is the most I can take in a day?
Answer
The Rx label says not to exceed 3,200 mg total daily dose. Your own dose comes from your prescriber.
Source section
DOSAGE AND ADMINISTRATION
Source
DailyMed Granules Rx label
Question
What are the most common side effects?
Answer
The most frequent type is gastrointestinal, reported by 4% to 16% of patients in controlled trials. Nausea, epigastric pain, heartburn, dizziness and rash each occurred in 3% to 9% of patients.
Source section
ADVERSE REACTIONS
Source
DailyMed Granules Rx label
Question
What serious risks does ibuprofen carry?
Answer
NSAIDs raise the risk of serious heart attack and stroke, which can be fatal, and of serious stomach and intestine bleeding, ulcers and holes. These can happen without warning symptoms.
Source section
BOXED WARNING
Source
DailyMed Granules Rx label
Question
Can I take ibuprofen while pregnant or breastfeeding?
Answer
Avoid use at about 30 weeks of pregnancy and later, and limit dose and duration between about 20 and 30 weeks. It is not known whether it passes into breast milk, so a decision should be made whether to stop nursing or the drug.
Source section
PRECAUTIONS, Pregnancy; Nursing Mothers
Source
DailyMed Granules Rx label
Question
What should I not combine with ibuprofen?
Answer
The label discusses ACE inhibitors, aspirin, diuretics such as furosemide and thiazides, lithium, methotrexate and warfarin-type anticoagulants. Taking ibuprofen with aspirin is not generally recommended.
Source section
DRUG INTERACTION
Source
DailyMed Granules Rx label
Question
What if I miss a dose?
Answer
MedlinePlus says if you take it regularly, take the missed dose as soon as you remember unless it is almost time for the next dose. Do not take a double dose.
Source section
What should I do if I forget a dose?
Source
MedlinePlus
Sources
- DailyMed Ibuprofen Rx Tablets, Granules India Limited (chosen)
Set id: 8804564c-9e1b-43c1-8b58-fd6ace645f00 · Label effective or revised date: Rev: July, 2024 (as printed at the end of the label; no 'Revised:' line was found) · Dailymed version date: DailyMed published date Oct 09, 2026 (from spls.json list) · Fetched at: 2026-11-02 · Sections used: Boxed Warning, Description, Clinical Pharmacology, Indications, Contraindications, Warnings, Precautions, Drug Interaction, Adverse Reactions, Overdosage, Dosage and Administration, How Supplied (page capped at 50,000 of 59,699 characters; end of Medication Guide not read) - MedlinePlus Ibuprofen
Label effective or revised date: Last Revised - 09/15/2023 · Fetched at: 2026-11-02 - DailyMed list API
Fetched at: 2026-11-02
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug