Prescription and over-the-counter medicine
Ibuprofen Brand names: Advil, Motrin, Caldolor, Ibu
Ibuprofen (Advil) is a prescription and over-the-counter medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 245 generic labelers, and pharmacies paid $0.0573 per ibuprofen 800 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ibuprofen FDA label on DailyMed (effective January 1, 2026, Savings Distributors LLC); the NDA 17463 record on Drugs@FDA; every ibuprofen label on DailyMed.
Highlights of the record
FDA label of January 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ).
This box is printed on the prescription label of ibuprofen; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usage■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever
Forms and strengths
- 100 mg
- 200 mg
- 256 mg
- 300 mg
- 400 mg
- 600 mg
- 800 mg
- 50 mg/1.25ml
- 100 mg/5ml
- 100 mg/10ml
- 100 mg/100ml
- 200 mg/1201
Film-coated tablet; tablet; suspension; liquid-filled capsule; coated tablet.
On the market
- Earliest approval on file
- September 19, 1974 Motrin, Mcneil Consumer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 163 first February 8, 1985; 65 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 250 of which 245 under generic applications, 9 under brand applications, repackagers included; 3 more under the over-the-counter monograph, without an application
- Last listed patent
- March 16, 2032 Caldolor injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0573 per tablet Ibuprofen 800 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 40 since 2013 1 Class I among all firms' recalls; latest March 2, 2026
- FAERS reports
- 270,516 through July 30, 2026
What is ibuprofen used for?
From the label: indications and usage■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever
Conditions named in the indications of ibuprofen's FDA labels, with every medicine labeled for each:
From other ibuprofen labelsFever: Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever
Osteoarthritis and Rheumatoid arthritis: Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Pain: Ibuprofen tablets are indicated for relief of mild to moderate pain.
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Motrin IB), NDA019012 (Kenvue Brands), as published by Savings Distributors LLC, effective January 1, 2026 (SPL set 56846774-8413-c306-e063-6394a90a2be8), via openFDA; the full label on DailyMed
What does the patient leaflet for ibuprofen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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
Source: FDA drug label (Ibuprofen), Granules Pharmaceuticals Inc., effective May 6, 2026 (SPL set 4aefcb3a-5dc8-b88e-e063-6294a90ac044), via openFDA; the full label on DailyMed
Is there a generic for ibuprofen (Advil)?
The FDA approved the first generic ibuprofen on February 8, 1985. 163 generic applications are approved; 65 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ibuprofen from 245 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Advil tablets; a patent listed only for Caldolor injection runs to March 16, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1974 earliest approval on file
- 1985 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ibuprofen (Advil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0573 per Ibuprofen 800 mg tablet, down 2% from $0.0587 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ibuprofen 800 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Children ibuprofen 100 mg/5 mL | Generic | $0.0301 per mL | n/a | +4% |
| Ft child ibuprofen 100 mg/5 mL | Generic | $0.0332 per mL | n/a | -2% |
| Ft ibuprofen 200 mg caplet | Generic | $0.0331 per unit | n/a | -9% |
| Ft ibuprofen 200 mg liquid gel | Generic | $0.0762 per unit | n/a | n/a |
| Ft ibuprofen 200 mg mini sfgl | Generic | $0.0762 per unit | n/a | -4% |
| Ft ibuprofen 200 mg softgel | Generic | $0.0762 per unit | n/a | -4% |
| Ft ibuprofen 200 mg tablet | Generic | $0.0331 per tablet | $0.994 | -9% |
| Ft ibuprofen ib 100 mg chewable tablet | Generic | $0.154 per tablet | $4.63 | +10% |
| Ft inf ibuprofen 50 mg/1.25 mL | Generic | $0.262 per mL | n/a | +1% |
| Gnp ibuprofen 100 mg chewable tablet | Generic | $0.154 per tablet | $4.63 | +10% |
| Gnp ibuprofen 200 mg mini sfgl | Generic | $0.0762 per unit | n/a | -4% |
| Gnp ibuprofen 200 mg softgel | Generic | $0.0762 per unit | n/a | -4% |
| Gnp ibuprofen 200 mg tablet | Generic | $0.0331 per tablet | $0.994 | -9% |
| Gs child ibuprofen 100 mg/5 mL | Generic | $0.0301 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ibuprofen been recalled?
The FDA's Enforcement Report lists 40 recalls naming ibuprofen since 2013: 1 Class I (the most serious), 37 Class II, 2 Class III; 7 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 2, 2026 | Class II | STRIDES PHARMA INC | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. |
| October 29, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Tablet/Capsule Specifications |
| August 9, 2024 | Class II | Direct Rx | Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. |
| August 8, 2024 | Class II | Preferred Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications - at 18-month Stability testing |
| August 6, 2024 | Class II | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| October 22, 2020 | Class III | Aurobindo Pharma USA Inc. | Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ibuprofen label say about other medicines?
The ibuprofen label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name ibuprofen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications (prescription label) | Ibuprofen tablets should not be given to patients who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Cimetidine | drug interactions (prescription label) | H-2 Antagonists In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of CALDOLOR and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of CALDOLOR and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of ibuprofen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see Warnings and Precautions () ]. Intervention: The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of CALDOLOR and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions (prescription label) | Diuretics Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions (prescription label) | Lithium Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CALDOLOR and pemetrexed, may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions (prescription label) | Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.) Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney … |
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CALDOLOR and pemetrexed, may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CALDOLOR and pemetrexed, may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of CALDOLOR and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Propranolol | drug interactions | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: During concomitant use of CALDOLOR and ACE-inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
Every other medicine the ibuprofen label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ranitidine | drug interactions (prescription label) | H-2 Antagonists In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. |
| Warfarin | drug interactions (prescription label) | 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. |
Other labels that name ibuprofen
Source: FDA drug label (Motrin IB), NDA019012 (Kenvue Brands), as published by Savings Distributors LLC, effective January 1, 2026 (SPL set 56846774-8413-c306-e063-6394a90a2be8), via openFDA; the full label on DailyMed
What do FAERS reports show for ibuprofen?
The FDA Adverse Event Reporting System holds 270,516 reports that list ibuprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,314 are coded as a death and 84,360 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibuprofen?
27 other medicines are given the same way (oral) and in the same FDA class as ibuprofen or labeled mainly for the same use (fever), the same class first. Fever lists all 8 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis, Cough and cold, Fever | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain, Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain, Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain, Cough and cold, Fever | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain, Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Nabumetone | Osteoarthritis, Rheumatoid arthritis | 28 labelers | $0.128 per tablet 500 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ibuprofen compare with medicines for the same use?
24 side-by-side pages set ibuprofen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ibuprofen
- 27 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Ibuprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other