Ibuprofen
Active ingredient · 5 therapeutic classes
Sold as Advil · Pedea · Dolex Flex · Ibuwin Forte · Medique Iprin
- Drug class
- Propionic Acid Derivatives
- Availability
- Prescription and OTC
- Routes
- Oral, Topical
- Markets covered
- 4
- Products on record
- 400
- FDA reports (12 mo)
- 12,556
Overview
Plain-language summary, compiled from the cited regulatory records
Ibuprofen is a medication belonging to the drug class of Other Cardiac Preparations [1]. It is approved for the temporary relief of minor aches and pains associated with conditions such as headache, toothache, backache, and menstrual cramps [1]. Ibuprofen is also indicated for relieving symptoms of the common cold, muscular aches, and minor pain due to arthritis [1]. Additionally, it temporarily reduces fever [1].
This active ingredient is available under various brand names, including Ibuprofen Dye Free, care one ibuprofen, and Ibuprofen [1]. In the past 12 months, there have been 12,600 adverse event reports associated with this ingredient [2]. The most frequently reported adverse events include claims of the drug being ineffective, off-label use, fatigue, nausea, and headache [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 230 | May 29, 2026 |
| CA Canada | Health Canada | 94 | May 27, 2026 |
| US United States | FDA | 74 | May 22, 2026 |
| EU European Union | EMA | 2 | February 16, 2026 |
GBUnited Kingdom· MHRA
230 products
Uses
This medicine (which contains codeine) is indicated in patients older than 12 years of age. g. paracetamol, ibuprofen or aspirin) alone, such as: rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea.
How to take
CACanada· Health Canada
94 products
Uses
SUDAFED® SINUS ADVANCE (Ibuprofen/Pseudoephedrine Hydrochloride) is indicated: • for temporary relief of symptoms associated with the common cold, sinusitis or flu including nasal congestion, headache, fever, body aches and pains. 1 Pediatrics Pediatrics (< 12 years of age): Based on the data submitted, the safety and efficacy of SUDAFED® SINUS ADVANCE is indicated in pediatric patients ≥ 12 years of age for the treatment of symptoms of colds including nasal congestion, sinus pain, headache, fever, body aches and pains (see 14 CLINICAL TRIALS).
The safety and efficacy of SUDAFED® SINUS ADVANCE in pediatric patients < 12 years of age have not been established. 2 Geriatrics Geriatrics (> 60 years of age): Caution should be observed in elderly patients, due to increased susceptibility to effects of sympathomimetic amines and increased risk of toxicity with ibuprofen, and patients with diminished renal function.
USUnited States· FDA
74 products
Uses
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
How to take
EUEuropean Union· EMA
2 products
Uses
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
How to take
Drug interactions
Known interactions involving Ibuprofen. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL000140662 · revised May 29, 2026
- [2]Health Canada (DPD) · 02242217 · revised May 20, 2026
- [3]FDA DailyMed · 121b13c8-0b1a-4c… · revised May 22, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/006129 · revised February 16, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.