Tradil (Dexibuprofen): Uses, Dosage & Side Effects
A prescription NSAID for osteoarthritis, menstrual pain, and mild to moderate pain relief
Tradil contains dexibuprofen, the pharmacologically active form of ibuprofen. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and is prescribed for adults to relieve pain and inflammation from osteoarthritis, menstrual cramps, and mild to moderate pain such as muscle aches, joint pain, and toothache. As the active enantiomer of ibuprofen, dexibuprofen provides equivalent efficacy at a lower dose, potentially offering better gastrointestinal tolerability.
Quick Facts
Key Takeaways
- Dexibuprofen is the active S(+)-enantiomer of ibuprofen, providing equivalent pain relief at roughly half the dose of racemic ibuprofen.
- Tradil is approved for osteoarthritis pain, menstrual cramps, and mild to moderate pain including muscle, joint, and dental pain.
- The maximum recommended dose is 1200 mg per day (four 300 mg tablets), and the lowest effective dose should be used for the shortest possible time.
- Like all NSAIDs, Tradil carries risks of gastrointestinal bleeding, cardiovascular events, and kidney problems, especially with prolonged use.
- Tradil must not be used in the last trimester of pregnancy and should be avoided in patients with active peptic ulcers, severe heart failure, or severe kidney or liver disease.
What Is Tradil and What Is It Used For?
Dexibuprofen, the active ingredient in Tradil, belongs to a class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by blocking the cyclooxygenase (COX) enzymes, which are responsible for producing prostaglandins — chemical messengers that play a central role in promoting inflammation, pain, and fever throughout the body. By reducing prostaglandin production, dexibuprofen effectively alleviates pain and decreases inflammation at the site of injury or disease.
What distinguishes dexibuprofen from the more widely known ibuprofen is its molecular structure. Ibuprofen exists as a racemic mixture of two mirror-image molecules (enantiomers): the S(+)-enantiomer and the R(-)-enantiomer. Only the S(+)-enantiomer — which is dexibuprofen — possesses the pharmacological activity responsible for pain relief and anti-inflammatory effects. The R(-)-enantiomer is essentially inactive and must be converted to the S(+) form in the body before it can contribute to the therapeutic effect. By using the pure active enantiomer, Tradil can achieve the same clinical benefits at approximately half the dose of racemic ibuprofen, which may translate into a reduced burden on the gastrointestinal system.
Tradil is approved for use in adults to treat the following conditions:
- Osteoarthritis: Pain and inflammation associated with degenerative joint disease, including stiffness and swelling of affected joints.
- Menstrual pain (dysmenorrhoea): Painful menstrual cramps caused by uterine prostaglandin release during menstruation.
- Mild to moderate pain: Including muscle aches, joint pain, toothache, headache, and post-procedural discomfort.
Clinical studies have demonstrated that dexibuprofen at doses of 200–400 mg provides comparable analgesic efficacy to 400–800 mg of racemic ibuprofen, with some evidence suggesting improved gastrointestinal tolerability. A systematic review published in the British Journal of Clinical Pharmacology confirmed that dexibuprofen offers a favourable benefit-risk profile for short-term pain management, particularly when gastrointestinal concerns are relevant.
It is important to note that Tradil is intended for symptom management and does not cure the underlying condition causing pain or inflammation. The lowest effective dose should always be used for the shortest duration necessary to control symptoms, in accordance with current international prescribing guidelines from the European Medicines Agency (EMA) and the World Health Organization (WHO).
What Should You Know Before Taking Tradil?
Contraindications
There are several situations in which Tradil must not be taken. Understanding these contraindications is essential for safe use. Do not take Tradil if you:
- Are allergic to dexibuprofen or any of the other ingredients in the tablet (hypromellos, microcrystalline cellulose, carmellose calcium, colloidal anhydrous silica, talc, titanium dioxide E171, triacetin, macrogol 6000).
- Have experienced allergic reactions to aspirin (acetylsalicylic acid) or other NSAIDs, including symptoms such as breathing difficulties, asthma, runny nose, skin rash, or facial swelling.
- Have previously experienced gastrointestinal bleeding or perforation caused by NSAID treatment.
- Have, or have had, recurrent peptic ulcers (stomach or duodenal ulcers), including signs such as bloody vomiting, black stools, or bloody diarrhoea.
- Have had cerebrovascular bleeding (brain haemorrhage) or any other active bleeding disorder.
- Have recently experienced a flare-up of inflammatory bowel disease such as ulcerative colitis or Crohn's disease.
- Suffer from severe dehydration caused by vomiting, diarrhoea, or inadequate fluid intake.
- Have severe heart failure, severe liver disease, or severe kidney disease.
- Are in the last three months of pregnancy.
- Have a condition of unknown origin resulting in abnormal blood cell formation.
Warnings and Precautions
Before starting Tradil, speak with your doctor or pharmacist if any of the following apply to you, as additional monitoring or dose adjustments may be necessary:
- History of stomach or duodenal ulcers, or inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- Liver or kidney disease, or alcohol dependence.
- Blood clotting disorders.
- Oedema (fluid retention in body tissues).
- Heart disease, high blood pressure, or a history of stroke or transient ischaemic attack (TIA).
- High cholesterol, diabetes, smoking, or a family history of heart disease or stroke.
- Systemic lupus erythematosus (SLE) or mixed connective tissue disease.
- Asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease (COPD) — as there is an increased risk of bronchospasm and allergic reactions.
- Recent major surgery.
- Hereditary blood formation disorders such as acute intermittent porphyria.
- Active infection — Tradil can mask signs of infection such as fever and pain, potentially delaying appropriate treatment.
Anti-inflammatory and analgesic medications such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses or for prolonged periods. Do not exceed the recommended dose or treatment duration. Discuss your cardiovascular risk factors with your doctor before starting treatment.
Gastrointestinal bleeding, ulceration, or perforation, which can be life-threatening, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms. The risk increases with higher doses, longer treatment duration, elderly patients, and those with a history of peptic ulcers. If GI bleeding or ulceration occurs, stop treatment immediately. Your doctor may prescribe a gastroprotective agent (e.g., a proton pump inhibitor or misoprostol) if you are at increased risk.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, and acute generalised exanthematous pustulosis (AGEP) have been reported in association with NSAID treatment. Stop taking Tradil immediately and seek medical attention if you develop any widespread rash, blisters, skin peeling, or rash with fever and swollen lymph nodes.
Tradil can mask signs of infection such as fever and pain. If you are taking this medicine while you have an infection and your symptoms persist or worsen, contact your doctor immediately. Avoid taking Tradil if you have chickenpox (varicella) or shingles (herpes zoster), as serious skin complications have been reported.
Pregnancy, Fertility, and Breastfeeding
Pregnancy: Tradil must not be used during the last three months (third trimester) of pregnancy, as it can cause serious harm to the unborn baby even at very low doses. Potential risks include kidney and heart problems in the foetus, effects on maternal and foetal bleeding tendency, and delayed or prolonged labour. During the first six months of pregnancy, Tradil should only be used if absolutely necessary and recommended by your doctor, at the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, even short-term use can cause kidney problems in the foetus, potentially leading to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Fertility: Tradil should not be used if you are planning to become pregnant, as it may make it more difficult to conceive. In rare cases, NSAIDs can affect female fertility. Fertility returns to normal after discontinuation.
Breastfeeding: Only small amounts of dexibuprofen pass into breast milk. However, you should not use Tradil for prolonged periods or at high doses while breastfeeding. Consult your doctor for advice.
Food, Drink, and Alcohol
Tradil can be taken without food, but taking it with a meal is recommended as this can help prevent stomach discomfort, particularly during long-term treatment. Tradil works faster when taken on an empty stomach. You should avoid or limit alcohol consumption while taking Tradil, as alcohol can worsen gastrointestinal side effects and increase the risk of stomach bleeding.
Driving and Operating Machinery
If you experience side effects such as dizziness, drowsiness, vertigo, or visual disturbances after taking Tradil, you should not drive or operate machinery. You are responsible for assessing your own fitness to drive or perform tasks requiring alertness.
How Does Tradil Interact with Other Drugs?
Drug interactions can alter the effectiveness of your medications or increase the risk of serious side effects. Tradil, like other NSAIDs, has a broad interaction profile. It is essential to inform your healthcare provider about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medications and herbal supplements.
Major Interactions — Avoid Concurrent Use
| Drug / Drug Class | Interaction Effect | Clinical Significance |
|---|---|---|
| Other NSAIDs (ibuprofen, naproxen, diclofenac) | Increased risk of gastrointestinal ulcers and bleeding | Do not combine; use only one NSAID at a time |
| Anticoagulants (warfarin, rivaroxaban, apixaban, dabigatran) | Prolonged bleeding time, increased bleeding risk | Close monitoring of INR and bleeding signs required |
| Low-dose aspirin (acetylsalicylic acid) | Increased GI bleeding risk; may reduce cardioprotective effect of aspirin | Use gastroprotective agent if combination unavoidable |
| Methotrexate | Reduced methotrexate clearance, increased toxicity | Requires close monitoring of blood counts and renal function |
Moderate Interactions — Use with Caution
| Drug / Drug Class | Interaction Effect | Clinical Significance |
|---|---|---|
| ACE inhibitors (e.g., captopril, enalapril) | Reduced antihypertensive effect; increased risk of kidney impairment | Monitor blood pressure and renal function |
| Beta-blockers (e.g., atenolol, metoprolol) | Reduced antihypertensive effect | Monitor blood pressure |
| ARBs (e.g., losartan, valsartan) | Reduced antihypertensive effect; increased risk of kidney impairment | Monitor blood pressure and renal function |
| Diuretics | Reduced diuretic effect; potassium-sparing diuretics may cause hyperkalaemia | Monitor electrolytes and renal function |
| Lithium | Increased lithium plasma levels | Monitor lithium levels closely |
| Corticosteroids | Increased risk of gastrointestinal ulceration and bleeding | Consider gastroprotective agent |
| SSRIs (e.g., fluoxetine, sertraline) | Increased risk of gastrointestinal bleeding | Monitor for signs of GI bleeding |
| Digoxin | Increased digoxin plasma levels | Monitor digoxin levels |
| Cyclosporine / Tacrolimus | Increased risk of nephrotoxicity | Monitor renal function closely |
| Phenytoin | Increased phenytoin plasma levels | Monitor phenytoin levels |
| Quinolone antibiotics | Increased risk of seizures | Use with caution in patients with seizure history |
| Voriconazole / Fluconazole (CYP2C9 inhibitors) | Increased dexibuprofen exposure | May require dose reduction of Tradil |
| Zidovudine | Increased risk of joint bleeding or haematoma | Monitor for bleeding signs |
This list is not exhaustive. Always tell your doctor or pharmacist about all medications you are taking, including supplements and herbal products. Sulfinpyrazone and probenecid (used for gout) may delay the excretion of dexibuprofen. Baclofen (a muscle relaxant) side effects may be increased when taken with Tradil. Pemetrexed (a cancer treatment) levels may be elevated when used concurrently with NSAIDs.
What Is the Correct Dosage of Tradil?
Always use Tradil exactly as your doctor has prescribed. Take the tablet with a glass of water or another liquid. Tradil works faster when taken on an empty stomach, but taking it with food is recommended to reduce the risk of gastrointestinal side effects, especially during prolonged treatment.
Adults
Osteoarthritis
The recommended dose is one tablet of Tradil 300 mg, two to three times daily (600–900 mg/day). During acute flare-ups, your doctor may increase the dose to a maximum of four tablets per day (1200 mg/day).
Menstrual Pain
The recommended dose is one tablet of Tradil 300 mg, two to three times daily (600–900 mg/day).
Mild to Moderate Pain
The recommended dose is one tablet of Tradil 300 mg, two times daily (600 mg/day). If higher doses are needed, your doctor may prescribe up to four tablets per day (1200 mg/day).
| Indication | Standard Dose | Maximum Daily Dose |
|---|---|---|
| Osteoarthritis | 300 mg 2–3 times/day | 1200 mg (4 tablets) |
| Menstrual pain | 300 mg 2–3 times/day | 900 mg (3 tablets) |
| Mild to moderate pain | 300 mg 2 times/day | 1200 mg (4 tablets) |
Children and Adolescents
Tradil is not recommended for use in children and adolescents under 18 years of age due to insufficient clinical experience in this population. If pain relief is needed for a child, consult your doctor for an appropriate alternative such as paracetamol (acetaminophen) or ibuprofen in paediatric formulations with well-established paediatric dosing.
Elderly Patients
If you are over 60 years of age, your doctor may prescribe a lower dose than usual. Elderly patients are at increased risk for gastrointestinal bleeding, ulceration, and perforation, as well as cardiovascular and renal side effects. If you tolerate the medication well, your doctor may consider increasing the dose. The lowest effective dose for the shortest duration should always be used in older adults.
Patients with Liver or Kidney Disease
Your doctor may prescribe a lower dose if you have liver or kidney impairment. Do not exceed the dose prescribed by your doctor. Kidney and liver function should be monitored regularly during treatment.
Missed Dose
If you forget to take a dose, do not take a double dose to make up for the missed tablet. Simply take your next dose at the usual time and continue your regular dosing schedule.
Overdose
If you take too many Tradil tablets, or if a child accidentally ingests the medication, contact your doctor, hospital emergency department, or poison control centre immediately. Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears (tinnitus), confusion, involuntary eye movements, and lack of coordination. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood pressure, chills, and breathing difficulties have been reported.
What Are the Side Effects of Tradil?
Like all medicines, Tradil can cause side effects, although not everybody gets them. Side effects are generally dose-dependent and vary between patients. Elderly patients are at increased risk of experiencing side effects. The risk of gastrointestinal adverse events is particularly dependent on dose and duration of treatment.
- Severe stomach pain, especially when you first start treatment
- Black stools, bloody diarrhoea, or vomiting blood
- Chest pain (potentially a sign of Kounis syndrome, a serious allergic reaction)
- Skin rash with blisters, skin peeling, mouth ulcers (signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
- Widespread rash with fever and swollen lymph nodes (DRESS syndrome)
- Red, scaly rash with bumps under the skin and blisters with fever (AGEP)
- Swelling of the face, tongue, or throat, difficulty breathing (angioedema)
- Yellowing of the skin and eyes (jaundice)
- Reduced urine output, swelling, or cloudy urine (signs of kidney damage)
Very Common
- Stomach pain and discomfort
- Nausea
- Indigestion (dyspepsia)
- Diarrhoea
- Flatulence (gas)
- Constipation
- Heartburn
- Vomiting
- Minor gastrointestinal blood loss (which may rarely cause anaemia)
Common
- Gastrointestinal ulcers, sometimes with bleeding and perforation
- Black stools (melaena)
- Blood-stained vomiting (haematemesis)
- Mouth ulcers and inflammation (ulcerative stomatitis)
- Colitis (inflammation of the large intestine)
- Worsening of inflammatory bowel disease
- Headache, dizziness
- Insomnia, agitation, irritability
- Drowsiness, vertigo, fatigue
Uncommon
- Gastritis
- Visual disturbances
- Hypersensitivity reactions (urticaria, itching, purpura, eczema)
- Asthma attacks (possibly with blood pressure drop)
- Swelling of face or throat (angioedema)
- Anxiety
- Tinnitus (ringing in the ears)
- Rhinitis (runny nose)
- Skin rash
- Oedema (fluid retention), especially in patients with hypertension or kidney problems
Rare and Very Rare
- Psychotic reactions, depression, confusion, hallucinations
- Visual loss (toxic amblyopia)
- Hearing impairment
- Kidney damage (papillary necrosis), renal failure
- Liver function problems, hepatitis, jaundice, liver failure
- Oesophageal or pancreatic inflammation
- Intestinal strictures (membrane-like narrowing)
- High blood pressure, vasculitis, palpitations, heart failure
- Blood disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis)
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP)
- Aseptic meningitis (especially in patients with autoimmune conditions)
- Worsening of infection-related inflammation (e.g., necrotising fasciitis)
- Severe generalised allergic reactions (anaphylactic shock)
- Photosensitivity reactions
- Hair loss (alopecia)
Medicines like Tradil may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed here. Reporting suspected adverse reactions after authorisation of the medicine is important for ongoing monitoring of the medicine's benefit-risk balance.
How Should You Store Tradil?
Proper storage of medication is important to maintain its effectiveness and safety. Follow these guidelines for storing Tradil:
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze.
- Keep out of reach: Store out of the sight and reach of children at all times.
- Expiry date: Do not use Tradil after the expiry date (marked "EXP" on the carton and blister pack). The expiry date refers to the last day of the stated month.
- Original packaging: Keep the tablets in the original blister packaging to protect from moisture and light.
- Disposal: Do not dispose of medications in wastewater or household waste. Return unused medicines to your pharmacy for safe disposal to protect the environment.
What Does Tradil Contain?
Understanding what your medication contains can help you identify potential allergens and understand its formulation.
Active Substance
Each film-coated tablet contains 300 mg dexibuprofen.
Inactive Ingredients (Excipients)
Tablet core: Hypromellose, microcrystalline cellulose, carmellose calcium, colloidal anhydrous silica, talc.
Film coating: Hypromellose, titanium dioxide (E 171), triacetin, talc, macrogol 6000.
Appearance and Pack Sizes
Tradil 300 mg tablets are white, round film-coated tablets with an approximate diameter of 11.2 mm and height of 5.2 mm. They are available in transparent, colourless PVC/PVDC/aluminium blister packs in cartons of 10, 20, 30, 50, 60, 90, and 100 tablets. Not all pack sizes may be marketed in every country.
International Brand Names
Dexibuprofen is marketed under different brand names in various countries across the European Economic Area:
- Austria: Dexibuprofen "Gebro" 300/400 mg
- Portugal: Seractil 300/400 mg
- Denmark: Seractiv 300/400 mg
- Spain: Seractil 400 mg
- Germany: Dolomagon 300/400 mg
- Italy: Seractil 300/400 mg
- Greece: Seractil 400 mg
Frequently Asked Questions About Tradil
Dexibuprofen is the pharmacologically active S(+)-enantiomer of ibuprofen. Standard ibuprofen (racemic ibuprofen) contains equal parts of two mirror-image molecules: the active S(+) form and the inactive R(-) form. Since only the S(+) enantiomer provides anti-inflammatory and analgesic effects, dexibuprofen achieves equivalent pain relief at approximately half the dose of racemic ibuprofen. For example, 300 mg of dexibuprofen provides similar efficacy to approximately 600 mg of ibuprofen. This lower dosing may result in fewer gastrointestinal side effects, though both medications carry similar NSAID-class risks.
No. Tradil (dexibuprofen) is classified as a prescription-only medication in most countries where it is marketed. This means you need a valid prescription from a doctor or other authorised healthcare provider. Your doctor will evaluate whether dexibuprofen is appropriate for your condition, taking into account your medical history, other medications, and risk factors for NSAID-related complications.
Tradil typically begins to relieve pain within 30 to 60 minutes after taking a tablet. The onset of action is faster when taken on an empty stomach. Maximum plasma concentrations of dexibuprofen are usually reached within 1 to 2 hours. For chronic conditions like osteoarthritis, you may notice the full anti-inflammatory benefit after several days of regular use, as prostaglandin suppression reaches a steady state.
Tradil must not be taken during the last three months (third trimester) of pregnancy. Even at very low doses, it can cause kidney and heart problems in the unborn baby, affect bleeding tendency, and delay or prolong labour. During the first six months, it should only be used when absolutely necessary and under medical supervision. From week 20 onwards, even short-term use can affect foetal kidney function. If you are pregnant, planning to become pregnant, or breastfeeding, always consult your doctor before taking any NSAID.
If you experience mild stomach discomfort, try taking Tradil with food and avoid alcohol. However, if you develop severe stomach pain, notice black or tarry stools, bloody diarrhoea, or vomit blood, stop taking Tradil immediately and seek emergency medical attention. These may be signs of gastrointestinal bleeding or ulceration, which can be life-threatening. Your doctor may prescribe a proton pump inhibitor (PPI) to protect your stomach lining if continued NSAID therapy is necessary.
You should avoid or significantly limit alcohol consumption while taking Tradil. Both alcohol and NSAIDs independently irritate the stomach lining and increase the risk of gastrointestinal bleeding. When used together, the risk is compounded, particularly with prolonged use. If you choose to drink alcohol, do so in moderation and be vigilant for signs of stomach irritation such as abdominal pain, nausea, or dark stools.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). Summary of Product Characteristics: Dexibuprofen film-coated tablets. European Public Assessment Reports. Available at: www.ema.europa.eu.
- Kaehler ST, Gust R, Engel T. Dexibuprofen: pharmacology, therapeutic uses, and safety profile. Drug Safety. 2003;26(3):185-195.
- Hawel R, Klein G, Singer F, et al. Comparison of the efficacy and tolerability of dexibuprofen and ibuprofen in the treatment of osteoarthritis of the hip. International Journal of Clinical Pharmacology and Therapeutics. 2003;41(4):153-164.
- Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. Circulation. 2008;118(18):1894-1909.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd List. 2023. Available at: www.who.int.
- British National Formulary (BNF). Non-steroidal anti-inflammatory drugs: prescribing information. NICE Evidence Services. Available at: bnf.nice.org.uk.
- Coxib and traditional NSAID Trialists' (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. The Lancet. 2013;382(9894):769-779.
- U.S. Food and Drug Administration (FDA). Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). 2023. Available at: www.fda.gov.
Medical Editorial Team
This article has been written and reviewed by iMedic's medical editorial team, comprising licensed physicians specialising in clinical pharmacology and internal medicine. All content follows the GRADE evidence framework and adheres to international guidelines from the EMA, WHO, and BNF.
All drug information is independently reviewed by board-certified clinical pharmacologists with no commercial affiliations.
Content is based on Level 1A evidence from systematic reviews, randomised controlled trials, and official regulatory documents (EMA SmPC, FDA labelling).
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