Ibuprofen
1. Disclaimer
This information is provided for educational and informational purposes only and is not intended to replace the official product information, prescribing information, patient information leaflet, or advice of a qualified healthcare professional. Product composition, strengths, indications, dosing recommendations, contraindications, warnings, availability, and regulatory status may differ between countries, formulations, and manufacturers.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
The information below refers primarily to ibuprofen-containing Brufen formulations and should not automatically be applied to combination products marketed under the Brufen name, such as Brufen Cold and Brufen Flu, which contain ibuprofen together with pseudoephedrine and therefore have additional indications, contraindications, precautions, and interactions. Current Egyptian pharmacy listings confirm the presence of such combination products.
2. Summary
Brufen® is a brand name used for medicinal products containing ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) of the propionic-acid derivative class.
Ibuprofen has analgesic, antipyretic, and anti-inflammatory properties. Its principal pharmacological action is inhibition of cyclooxygenase (COX) enzymes, resulting in reduced prostaglandin synthesis.
Brufen products are available in several oral formulations and strengths. Current Egyptian listings identify, among others, Brufen 100 mg/5 mL oral suspension, 200 mg tablets, 400 mg tablets, 600 mg tablets, 600 mg effervescent granules/sachets, and Brufen Retard 800 mg modified-release tablets. Egyptian pharmacy listings also show Brufen Cold and Brufen Flu products, but these are ibuprofen/pseudoephedrine combination products and should be considered separately.
Ibuprofen is used for the symptomatic treatment of pain, inflammation, and fever and for a number of rheumatological and musculoskeletal conditions, depending on the specific formulation and approved product information.
3. Brand Name
Brufen®
Active ingredient: Ibuprofen.
The Brufen brand is represented by several formulations and strengths in the Egyptian market, including:
- Brufen 100 mg/5 mL oral suspension, 150 mL.
- Brufen 200 mg tablets.
- Brufen 400 mg tablets.
- Brufen 600 mg tablets.
- Brufen 600 mg effervescent granules/sachets, including 10- and 20-sachet presentations.
- Brufen Retard 800 mg modified-release tablets.
Current Egyptian pharmacy listings support the continued availability of several of these presentations.
Important: Brufen Cold and Brufen Flu should not be treated as simple alternative presentations of ibuprofen because they contain ibuprofen + pseudoephedrine.
4. Category
Pharmacological class:
- Non-steroidal anti-inflammatory drug (NSAID).
- Propionic acid derivative.
- Analgesic.
- Antipyretic.
- Anti-inflammatory.
Ibuprofen exerts its principal therapeutic effects through inhibition of prostaglandin synthesis via cyclooxygenase inhibition.
5. Active Ingredient
Ibuprofen
Ibuprofen is the active pharmaceutical ingredient in the standard Brufen formulations addressed in this monograph.
The active ingredient should not be confused with the combination formulations marketed as Brufen Cold or Brufen Flu, where pseudoephedrine is also present.
6. Pharmaceutical Form & Strength
Documented Brufen formulations include:
| Formulation | Strength |
|---|---|
| Oral suspension | 100 mg/5 mL |
| Tablets | 200 mg |
| Tablets | 400 mg |
| Film-coated tablets | 600 mg |
| Effervescent granules/sachets | 600 mg |
| Modified/sustained-release tablets (Brufen Retard) | 800 mg |
Current Egyptian listings support the presence of 100 mg/5 mL suspension, 200 mg, 400 mg, 600 mg, 600 mg sachets, and 800 mg modified-release products.
The exact excipients, packaging, shelf life, and approved indications may vary between individual formulations and markets.
7. Manufacturer & Marketing Authorization Holder
The supplied Egyptian market data identifies the manufacturing chain as:
Kahira Pharmaceuticals & Chemical Industries Company — under licence of Abbott Laboratories, USA.
Contemporary Egyptian drug listings continue to identify Brufen products with the manufacturer designation Kahira > Abbott Laboratories.
However, manufacturer, licence holder, brand owner, and legal Marketing Authorization Holder (MAH) are not necessarily interchangeable regulatory terms. The available public Egyptian sources reviewed do not provide sufficient evidence to independently establish the exact current legal MAH for every Brufen presentation.
Therefore, the official Egyptian registration record or current package leaflet should be used when an exact regulatory MAH statement is required.
8. Mechanism of Action
Ibuprofen is a non-selective cyclooxygenase inhibitor.
It inhibits COX-mediated prostaglandin synthesis, reducing the production of prostaglandins involved in pain, inflammation, and fever.
This pharmacological activity accounts for its:
- Analgesic effect.
- Anti-inflammatory effect.
- Antipyretic effect.
Ibuprofen also affects platelet aggregation and can prolong bleeding time, although its antiplatelet effect is less persistent than that of aspirin.
9. Spectrum of Activity
Not applicable in the antimicrobial sense.
Brufen/ibuprofen is not an antibacterial, antiviral, antifungal, or antiparasitic medicine, and therefore it does not have an antimicrobial "spectrum of activity."
Its pharmacological activity is directed toward the symptomatic modulation of:
- Pain.
- Fever.
- Inflammation.
It may reduce symptoms associated with a variety of inflammatory, musculoskeletal, rheumatological, and painful conditions, but it does not eradicate the underlying infectious organism when an infection is present.
10. Pharmacokinetics
Ibuprofen is rapidly absorbed following oral administration.
For conventional oral formulations:
- Peak serum/plasma concentrations are generally reached approximately 1–2 hours after administration.
- The elimination half-life is approximately 2 hours, although values can vary somewhat according to formulation and patient characteristics.
- Ibuprofen is extensively bound to plasma proteins.
- It undergoes hepatic metabolism to pharmacologically inactive metabolites.
- Metabolites, together with a small amount of unchanged drug, are eliminated predominantly through the kidneys.
Food may delay the attainment of peak plasma concentrations without necessarily preventing absorption.
Modified-release formulations such as Brufen Retard 800 mg have a different release profile and should not be assumed to have identical pharmacokinetic characteristics to immediate-release ibuprofen tablets.
11. Indications
Depending on the specific formulation and approved product information, ibuprofen is indicated for symptomatic treatment of conditions including:
- Rheumatoid arthritis.
- Juvenile idiopathic/rheumatoid arthritis in appropriate patients.
- Ankylosing spondylitis.
- Osteoarthritis.
- Other inflammatory or non-rheumatoid musculoskeletal conditions.
- Acute gout.
- Periarticular conditions such as bursitis, tendinitis, tenosynovitis, and frozen shoulder.
- Low-back pain.
- Soft-tissue injuries such as sprains and strains.
- Mild-to-moderate pain.
- Dental pain.
- Post-operative pain.
- Dysmenorrhoea.
- Headache and migraine.
- Fever and other painful inflammatory conditions where ibuprofen is an approved treatment.
The exact approved indication set depends on the individual product, strength, formulation, and jurisdiction; therefore, the relevant official product information should be checked before attributing a particular indication to every Brufen presentation.
12. Administration
Brufen is administered orally in the formulations covered here.
General administration principles include:
- Use the lowest effective dose for the shortest duration necessary to control symptoms.
- Conventional tablets should be taken with sufficient fluid.
- In patients with sensitive stomachs, administration with or after food may be preferable, although food may delay absorption.
- Modified-release tablets should be administered according to their specific product instructions and should not be treated as equivalent to immediate-release tablets.
For adult prescription-strength Brufen formulations, the exact dose depends on the indication and formulation. Current Brufen SmPC information for 400 mg tablets describes individualized dosing within the approved range, while the maximum daily dose for the prescription-strength regimen may reach 2400 mg/day under appropriate medical supervision.
Children: dosing must be based on the specific pediatric formulation, age, and body weight. The 600 mg and 800 mg formulations are not interchangeable with pediatric suspension dosing. Current Brufen information states that conventional Brufen tablets are not suitable for children under 12 years, while pediatric formulations may be used according to weight and product-specific instructions.
13. Method of Preparation
For Brufen oral suspension, the product should be used according to the instructions supplied with the marketed formulation.
For Brufen 600 mg effervescent granules/sachets, the granules are intended to be dispersed/dissolved in water according to the product instructions before oral administration.
The exact preparation method, volume of water, shaking requirements, and administration instructions should be taken from the current package leaflet for the specific Egyptian presentation, because these instructions are formulation-specific.
Do not extrapolate preparation instructions from one Brufen formulation to another.
14. Contraindications
Ibuprofen-containing Brufen products are contraindicated or should not be used in patients with relevant conditions including:
- Hypersensitivity to ibuprofen or any formulation-specific excipient.
- Previous hypersensitivity reactions such as asthma, urticaria, angioedema, or rhinitis triggered by aspirin or other NSAIDs.
- Previous NSAID-associated gastrointestinal bleeding or perforation.
- Active or recurrent peptic ulcer disease or gastrointestinal haemorrhage, including patients with two or more distinct documented episodes.
- Conditions associated with significant bleeding tendency.
- Severe heart failure, particularly NYHA class IV in the cited Brufen SmPC.
- Severe renal failure.
- Severe hepatic failure.
- Active significant bleeding where specified by the applicable product information.
- The last trimester of pregnancy.
Brufen is also contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Contraindications can differ slightly between formulations and jurisdictions; the current product-specific prescribing information should therefore be regarded as controlling.
15. Warnings & Precautions
Important precautions associated with ibuprofen include:
Gastrointestinal risk
NSAIDs can cause gastrointestinal ulceration, bleeding, and perforation, potentially without warning symptoms. Risk increases with higher doses, prolonged treatment, older age, and a history of peptic ulcer disease or gastrointestinal bleeding.
Cardiovascular risk
NSAIDs may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. Risk may increase with dose and duration of treatment. Patients with cardiovascular disease or cardiovascular risk factors require particular caution.
Renal effects
Ibuprofen can reduce renal prostaglandin synthesis and may precipitate renal impairment, particularly in patients who are dehydrated or who have renal impairment, heart failure, hepatic dysfunction, or are receiving medicines that affect renal perfusion.
Hypertension and fluid retention
NSAIDs may cause fluid retention and oedema and may worsen hypertension or heart failure.
Asthma and hypersensitivity
Bronchospasm and other hypersensitivity reactions may occur, particularly in patients with NSAID-exacerbated respiratory disease.
Skin reactions
Rare but serious cutaneous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Treatment should be discontinued when appropriate if serious skin or mucosal reactions occur.
Masking of infection
Like other NSAIDs, ibuprofen may mask signs and symptoms of infection.
Bleeding
Ibuprofen can inhibit platelet aggregation and prolong bleeding time, increasing concern in patients with bleeding disorders or concomitant medicines that increase bleeding risk.
Medication-overuse headache
Frequent or prolonged use of analgesics for headache may contribute to medication-overuse headache; increasing the analgesic dose is not an appropriate response to such a pattern.
16. Drug Interactions
Clinically relevant interactions include:
- Other NSAIDs / COX-2 inhibitors: increased risk of gastrointestinal and other NSAID-related adverse effects; concomitant use should generally be avoided.
- Aspirin: ibuprofen may interfere with the antiplatelet effect of low-dose aspirin when administered concomitantly.
- Anticoagulants, including warfarin: increased risk of bleeding.
- Antiplatelet agents: increased bleeding risk.
- SSRIs: increased gastrointestinal bleeding risk.
- Corticosteroids: increased risk of gastrointestinal ulceration and bleeding.
- ACE inhibitors, ARBs, beta-blockers, and diuretics: NSAIDs may reduce antihypertensive effects and may increase renal risk in susceptible patients.
- Lithium: NSAIDs may reduce lithium elimination and increase lithium exposure.
- Methotrexate: NSAIDs may reduce methotrexate clearance and increase toxicity risk.
- Cyclosporine and tacrolimus: increased risk of nephrotoxicity.
- Cardiac glycosides: NSAIDs may worsen cardiac failure, reduce renal function, and increase glycoside concentrations.
- Aminoglycosides: NSAIDs may reduce renal elimination of aminoglycosides.
- Sulfonylureas: possible potentiation of hypoglycaemic effects.
- Zidovudine: increased risk of haematological toxicity and bleeding complications in certain patients.
- Quinolone antibiotics: NSAIDs may increase the risk of convulsions.
- CYP2C9 inhibitors: potent inhibitors such as fluconazole or voriconazole can increase ibuprofen exposure; dose adjustment may need to be considered, particularly with high-dose ibuprofen.
The interaction profile must also be evaluated against the patient's complete medication list and the specific Brufen formulation.
17. Side Effects
Reported adverse effects include:
Gastrointestinal
- Dyspepsia.
- Abdominal pain.
- Nausea.
- Vomiting.
- Diarrhoea.
- Constipation.
- Flatulence.
- Gastritis.
- Peptic ulceration.
- Gastrointestinal bleeding.
- Gastrointestinal perforation.
- Rare pancreatitis.
Hypersensitivity / respiratory
- Rash.
- Pruritus.
- Urticaria.
- Angioedema.
- Bronchospasm.
- Asthma exacerbation.
- Dyspnoea.
- Anaphylactic reactions.
Nervous system
- Headache.
- Dizziness.
- Somnolence.
- Paraesthesia.
- Rare aseptic meningitis.
Renal
- Renal impairment.
- Interstitial nephritis.
- Nephrotic syndrome.
- Renal failure.
- Other forms of NSAID-associated nephrotoxicity.
Hepatic
- Abnormal liver function.
- Hepatitis.
- Jaundice.
- Rare hepatic failure.
Haematological
- Thrombocytopenia.
- Leukopenia.
- Neutropenia.
- Agranulocytosis.
- Aplastic anaemia.
- Haemolytic anaemia.
Cardiovascular
- Oedema.
- Hypertension or worsening of hypertension.
- Heart failure exacerbation.
- Increased risk of arterial thrombotic events with NSAID use, particularly at higher doses and with prolonged treatment.
Dermatological
Rare serious reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and other severe cutaneous adverse reactions.
The frequency and severity of adverse reactions vary with dose, duration, patient characteristics, and concomitant medicines.
18. Use in Special Populations
Pregnancy
Ibuprofen and other NSAIDs require particular caution during pregnancy.
Current regulatory safety information recommends avoiding NSAIDs at 20 weeks of gestation or later unless specifically justified by a healthcare professional because fetal renal dysfunction and oligohydramnios can occur. NSAIDs should generally be avoided from around 30 weeks onward because of the additional risk of premature closure of the fetal ductus arteriosus.
The cited Brufen SmPC contraindicates use during the last trimester. Therefore, pregnancy information should not be reduced to the older statement that ibuprofen is simply "contraindicated in the third trimester"; contemporary safety guidance is more nuanced and introduces important precautions from 20 weeks onward.
Breastfeeding
Ibuprofen appears in breast milk in very low concentrations. Available product information generally considers exposure through breast milk to be low; however, the decision to use ibuprofen during lactation should consider the individual clinical situation and the current product information rather than using an absolute statement that it is universally contraindicated.
Children
Pediatric dosing is weight- and formulation-dependent. Brufen pediatric suspension is distinct from high-strength tablets and modified-release formulations. Brufen Retard 800 mg is not recommended for children under 12 years according to its SmPC.
Elderly
Older adults have a higher risk of serious NSAID adverse effects, particularly gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular complications. The lowest effective dose for the shortest appropriate duration should generally be considered.
Renal impairment
Ibuprofen should be used cautiously in renal impairment. Severe renal failure is a contraindication in the cited Brufen product information.
Hepatic impairment
Dose and treatment appropriateness should be assessed carefully in hepatic impairment; severe hepatic failure is contraindicated in the cited Brufen information.
Cardiovascular disease
Patients with hypertension, heart failure, ischemic heart disease, cerebrovascular disease, or other cardiovascular risk factors require careful assessment because NSAIDs can cause fluid retention and increase cardiovascular risk.
19. Storage Conditions
Storage requirements are formulation-specific and should not be generalized across every Brufen presentation.
For example, the current Brufen 400 mg SmPC specifies storage in the original package at a temperature not exceeding 25°C.
Brufen 600 mg granules are also listed with storage below 25°C in the cited SmPC.
Therefore, the safest professional wording is:
- Store according to the temperature specified on the current package/leaflet.
- Keep the medicine in its original packaging where specified.
- Protect the product from unsuitable environmental conditions according to the individual formulation.
- Keep out of the reach of children.
- Do not use after the stated expiry date.
Correction to the original text: the blanket statement "store at a temperature not exceeding 30°C" should not be retained as a universal storage instruction for all Brufen formulations.
20. Additional Sections
Overdose
Ibuprofen overdose can produce gastrointestinal symptoms such as nausea, vomiting, and abdominal pain, together with neurological manifestations such as dizziness, drowsiness, headache, tinnitus, or, in severe cases, seizures and loss of consciousness.
Severe poisoning may involve:
- Gastrointestinal bleeding.
- Metabolic acidosis.
- Renal impairment or renal failure.
- Hypotension.
- Bradycardia or tachycardia.
- Respiratory or CNS depression.
- Coma.
There is no specific antidote for ibuprofen poisoning. Management is supportive and should be guided by the severity of exposure and appropriate toxicological/poison-control advice.
The original text's statement that gastric emptying should routinely be performed above a specific dose threshold should not be retained as a general self-contained treatment instruction. Management of overdose should follow current toxicology guidance and local poison-control recommendations.
Effects on Driving and Machinery
Dizziness, drowsiness, visual disturbances, or other CNS effects may occur in some patients. Individuals experiencing such effects should avoid driving or operating machinery requiring full alertness.
Fertility
NSAIDs including ibuprofen may affect female fertility by inhibiting prostaglandin synthesis and may interfere with ovulation. This effect is generally reversible after discontinuation. Women experiencing difficulty conceiving or undergoing infertility investigation should discuss prolonged NSAID use with a healthcare professional.
21. Frequently Asked Questions (FAQ)
What is Brufen?
Brufen is a brand name used for medicinal products containing ibuprofen, an NSAID with analgesic, antipyretic, and anti-inflammatory activity.
What is the active ingredient in Brufen?
The active ingredient in standard Brufen formulations is ibuprofen.
Is Brufen an antibiotic?
No. Ibuprofen is not an antibiotic and does not treat bacterial infections.
What is Brufen used for?
Depending on the formulation and approved indication, it is used to relieve pain, reduce fever, and treat inflammatory and rheumatological or musculoskeletal conditions.
Are all Brufen products the same?
No. Brufen is marketed in different strengths and dosage forms. Brufen Cold and Brufen Flu also contain pseudoephedrine and therefore have a different pharmacological and safety profile from ibuprofen-only Brufen products.
Can Brufen be used during pregnancy?
Ibuprofen requires particular caution during pregnancy. Current FDA safety guidance recommends avoiding NSAIDs from 20 weeks of pregnancy unless specifically advised by a healthcare professional, with avoidance generally recommended from 30 weeks because of additional fetal risks.
Can ibuprofen be used while breastfeeding?
Ibuprofen enters breast milk in very low concentrations. However, use during breastfeeding should still be assessed in the context of the individual patient and current product information.
Can Brufen be taken with aspirin?
Concomitant use requires caution because ibuprofen can interfere with the antiplatelet effect of low-dose aspirin and may also increase adverse-effect risk.
Can Brufen be taken with another NSAID?
Combining ibuprofen with another NSAID is generally discouraged because it can increase NSAID-related adverse effects, particularly gastrointestinal toxicity.
Does Brufen have anti-inflammatory activity?
Yes. Ibuprofen inhibits cyclooxygenase-mediated prostaglandin synthesis and consequently has anti-inflammatory activity.
Does Brufen cause stomach problems?
Yes. NSAIDs including ibuprofen can cause dyspepsia, ulceration, gastrointestinal bleeding, and, rarely, perforation. The risk increases with dose and duration and in susceptible patients.
22. References
- Electronic Medicines Compendium (emc) — Brufen 400 mg Tablets, Summary of Product Characteristics. Current version reviewed/updated April 2026.
- Electronic Medicines Compendium (emc) — Brufen Retard 800 mg, Summary of Product Characteristics. Current version reviewed/updated October 2025.
- Electronic Medicines Compendium (emc) — Brufen 600 mg Granules, Summary of Product Characteristics.
- U.S. Food and Drug Administration (FDA) — NSAID use in pregnancy from 20 weeks onward.
- U.S. Food and Drug Administration (FDA) — Information about taking ibuprofen and aspirin together.
- Current Egyptian pharmacy/drug listings documenting Brufen formulations available in Egypt, including 100 mg/5 mL suspension, 200 mg, 400 mg, 600 mg, 600 mg sachets, and 800 mg modified-release products.
- Egyptian pharmacy listings for Brufen Cold and Brufen Flu, confirming that these are ibuprofen/pseudoephedrine combination products and should be distinguished from ibuprofen-only Brufen formulations.
Verification note: Public Egyptian pharmacy listings can demonstrate current market presence, but they should not be treated as the definitive regulatory register. For definitive Egyptian registration status, legal MAH information, exact approved indications, current package sizes, and current regulatory wording, the latest official Egyptian Drug Authority record and the current manufacturer-approved package leaflet should take precedence.