Flurbiprofen STADA: Uses, Dosage & Side Effects
A non-steroidal anti-inflammatory drug (NSAID) for short-term relief of sore throat pain, available as lozenges and oromucosal spray
Flurbiprofen STADA is a locally acting non-steroidal anti-inflammatory drug (NSAID) used for the short-term symptomatic relief of sore throat pain. Available as 8.75 mg lozenges and a 16.2 mg/ml oromucosal spray solution, flurbiprofen works by inhibiting cyclooxygenase enzymes (COX-1 and COX-2) to reduce prostaglandin synthesis directly at the site of throat inflammation. It provides rapid pain relief, typically within 15–30 minutes, lasting up to 4–6 hours. Flurbiprofen STADA is intended for adults and adolescents aged 12 years and over, and should not be used for more than 3 days without medical advice.
Quick Facts: Flurbiprofen STADA
Key Takeaways
- Flurbiprofen STADA is an NSAID lozenge and spray that provides targeted anti-inflammatory pain relief for sore throats caused by pharyngitis and tonsillitis
- Pain relief typically begins within 15–30 minutes and lasts 4–6 hours per dose, with a maximum of 5 lozenges or 5 spray doses per day
- Not recommended for children under 12, during the third trimester of pregnancy, or for use beyond 3 consecutive days without medical supervision
- Avoid combining with other NSAIDs (including aspirin and ibuprofen) and use caution with anticoagulants such as warfarin due to increased bleeding risk
- Common side effects are generally mild and include taste disturbance, oral numbness, and gastrointestinal discomfort; serious reactions are rare at recommended doses
What Is Flurbiprofen STADA and What Is It Used For?
Flurbiprofen STADA contains the active ingredient flurbiprofen, a member of the propionic acid class of NSAIDs. Unlike systemic NSAID tablets taken for general pain relief, Flurbiprofen STADA is formulated specifically for local application to the oropharyngeal mucosa – the tissue lining the back of the throat. When you slowly dissolve a lozenge or apply the spray, the flurbiprofen is delivered directly to the inflamed tissue, providing targeted anti-inflammatory and analgesic (pain-relieving) effects at the site where you need it most.
The drug works by inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. These enzymes are responsible for producing prostaglandins, which are chemical messengers that play a key role in the inflammatory response. By blocking prostaglandin synthesis locally in the throat, flurbiprofen reduces the swelling, redness, and pain associated with sore throat conditions. Clinical studies have demonstrated that a single 8.75 mg flurbiprofen lozenge provides statistically significant pain relief compared to placebo within 15 minutes of administration, with the effect lasting between 4 and 6 hours.
Flurbiprofen STADA is indicated for the symptomatic relief of sore throat pain in adults and adolescents aged 12 years and over. It is effective for sore throat caused by viral pharyngitis (the most common cause of sore throat), bacterial pharyngitis, tonsillitis, and general upper respiratory tract infections. However, it is important to understand that Flurbiprofen STADA treats the symptom of pain only – it does not treat the underlying infection. If your sore throat is caused by a bacterial infection such as group A streptococcus, you may still require antibiotic treatment as prescribed by your doctor.
Flurbiprofen is approximately 5–10 times more potent than ibuprofen on a weight-for-weight basis, which explains why such a low dose (8.75 mg) can provide meaningful analgesic effects. For comparison, a typical ibuprofen tablet contains 200–400 mg of active ingredient. The low dose used in the lozenge and spray formulations results in minimal systemic absorption, which means the risk of typical NSAID-related systemic side effects (such as gastrointestinal ulceration or cardiovascular events) is considerably lower than with oral NSAID tablets taken for musculoskeletal pain.
What Should You Know Before Taking Flurbiprofen STADA?
Before using Flurbiprofen STADA, it is essential to consider several important safety factors. Although the locally applied low-dose formulation carries a more favourable safety profile than systemic NSAID tablets, the same fundamental precautions that apply to all NSAIDs should be respected. Understanding these contraindications and warnings will help you use the product safely and effectively.
Contraindications
You must not use Flurbiprofen STADA if any of the following apply to you:
- Hypersensitivity to flurbiprofen or any excipient – If you have ever had an allergic reaction to flurbiprofen or any of the inactive ingredients in the lozenge or spray, do not use this product.
- History of reactions to aspirin or other NSAIDs – Patients who have experienced asthma, urticaria (hives), rhinitis, or angioedema triggered by aspirin or any other NSAID must avoid flurbiprofen, as cross-reactivity is common within this drug class.
- Active peptic ulcer or gastrointestinal bleeding – Although the locally applied dose is very low, it is contraindicated in patients with active gastrointestinal ulceration or bleeding.
- Third trimester of pregnancy – All NSAIDs are contraindicated after the 28th week of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and inhibition of uterine contractions.
- Severe heart failure (NYHA Class IV) – NSAID use may worsen fluid retention and cardiac function in patients with severe heart failure.
- Severe hepatic or renal impairment – Patients with significantly compromised liver or kidney function should not use this product without specific medical advice.
Warnings and Precautions
Use Flurbiprofen STADA with caution and consult your doctor before use if you have any of the following conditions:
- History of gastrointestinal disease – Including Crohn’s disease, ulcerative colitis, or previous peptic ulcer. NSAIDs can potentially exacerbate these conditions, even at low doses.
- Cardiovascular disease – Including hypertension, ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease. Although the systemic exposure from lozenges is minimal, patients with significant cardiovascular risk should consult their physician.
- Asthma – Approximately 10–20% of adults with asthma may experience NSAID-exacerbated respiratory disease (NERD). If you have asthma, use flurbiprofen with caution and discontinue immediately if you notice any worsening of respiratory symptoms.
- Elderly patients – Older adults are at increased risk of NSAID-related adverse effects. While the low-dose topical formulation is generally well tolerated, elderly patients should use the minimum effective dose for the shortest duration necessary.
- Coagulation disorders – Flurbiprofen, like all NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Use with caution if you have a bleeding disorder or are taking anticoagulant medications.
Pregnancy and Breastfeeding
The use of Flurbiprofen STADA during pregnancy requires careful consideration depending on the trimester:
- First and second trimester – Use only if clearly necessary and as advised by your doctor. NSAIDs may be associated with an increased risk of miscarriage and malformations when used during early pregnancy, though evidence for low-dose topical formulations is limited.
- Third trimester – Absolutely contraindicated. All NSAIDs may cause premature closure of the ductus arteriosus in the fetus, inhibit uterine contractions (potentially prolonging labour), and increase the risk of maternal and fetal bleeding.
- Breastfeeding – Flurbiprofen is excreted in breast milk in very small quantities. Given the low systemic dose from lozenges, short-term use (up to 3 days) is generally considered compatible with breastfeeding by most clinical references, including the British National Formulary (BNF). However, you should consult your healthcare provider before use.
How Does Flurbiprofen STADA Interact with Other Drugs?
Drug interactions with flurbiprofen lozenges and spray are generally less clinically significant than those associated with systemic NSAID therapy, because the locally applied low dose results in considerably lower blood levels of the drug. However, it is important to be aware of potential interactions, especially if you take other medications regularly or have underlying health conditions. The table below summarizes the most important known interactions.
Major Interactions
The following drug combinations warrant particular caution and may require medical supervision:
| Interacting Drug | Risk | Recommendation |
|---|---|---|
| Warfarin / Anticoagulants | Increased risk of bleeding due to additive antiplatelet effects and potential displacement from protein binding | Avoid combination or use under close medical supervision with INR monitoring |
| Other NSAIDs (incl. aspirin) | Increased risk of gastrointestinal ulceration and bleeding; no additional analgesic benefit | Do not use Flurbiprofen STADA concurrently with other NSAIDs or aspirin (except low-dose aspirin for cardiovascular prophylaxis on medical advice) |
| Methotrexate | NSAIDs may reduce renal clearance of methotrexate, leading to increased toxicity | Consult your doctor; particularly relevant for patients on high-dose methotrexate therapy |
| Lithium | NSAIDs may decrease lithium renal excretion, leading to elevated plasma lithium levels and toxicity | Monitor lithium levels if concurrent use cannot be avoided |
Minor Interactions
The following interactions are less likely to be clinically significant with the low-dose topical formulation, but awareness is still important:
| Interacting Drug | Risk | Recommendation |
|---|---|---|
| SSRIs (e.g. sertraline, fluoxetine) | Slightly increased risk of gastrointestinal bleeding when combined with NSAIDs | Be aware of symptoms; short-term use is generally acceptable |
| Corticosteroids (e.g. prednisolone) | Increased risk of gastrointestinal ulceration and bleeding | Use with caution; consider gastroprotection if both are needed |
| ACE inhibitors / ARBs | NSAIDs may reduce the antihypertensive effect and potentially impair renal function | Unlikely to be significant at lozenge doses; inform your doctor if you take blood pressure medication |
| Diuretics | NSAIDs may reduce the diuretic and antihypertensive effect | Unlikely to be clinically relevant at topical doses; monitor blood pressure if concerned |
| Ciclosporin | Increased risk of nephrotoxicity | Consult your doctor before using any NSAID if you take ciclosporin |
Always inform your pharmacist or doctor about all medications you are taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. Even though the systemic exposure from flurbiprofen lozenges is low, drug interactions can still occur, particularly in patients who are elderly, have impaired kidney or liver function, or are taking multiple medications simultaneously.
What Is the Correct Dosage of Flurbiprofen STADA?
The correct dosage of Flurbiprofen STADA depends on the formulation being used. Both the lozenge and spray formulations deliver flurbiprofen locally to the throat, but the administration method and dosing intervals differ slightly. Always follow the instructions provided in the patient information leaflet, and do not exceed the recommended dose. Using the product correctly ensures optimal pain relief while minimising the risk of side effects.
Adults
Lozenge (8.75 mg)
Slowly dissolve one lozenge in the mouth every 3 to 6 hours as needed. Do not chew or swallow the lozenge whole – allow it to dissolve slowly to maximise local contact with the throat tissue. The maximum recommended dose is 5 lozenges per day (43.75 mg total daily dose of flurbiprofen). Use the lowest effective dose for the shortest duration necessary. Do not use for more than 3 consecutive days without consulting a healthcare professional.
Oromucosal Spray (16.2 mg/ml)
Direct 3 sprays (one dose) onto the back of the throat every 3 to 6 hours as needed. Each spray delivers approximately 0.27 ml of solution, providing around 4.4 mg of flurbiprofen per spray (approximately 13.2 mg per 3-spray dose). The maximum recommended frequency is 5 doses (15 sprays) per day. Do not inhale while spraying. Do not use for more than 3 consecutive days without consulting a healthcare professional.
Children
Children Under 12 Years
Flurbiprofen STADA lozenges and spray are not recommended for children under 12 years of age. There is insufficient clinical data on the safety and efficacy of flurbiprofen lozenges in this age group. For younger children with sore throat pain, consult a healthcare provider for age-appropriate alternatives, such as paracetamol (acetaminophen) or ibuprofen oral suspensions, which have well-established paediatric dosing.
Adolescents (12–17 Years)
The same dosing as adults applies: one lozenge every 3–6 hours or 3 sprays every 3–6 hours, with a maximum of 5 doses per day. Use should be under adult supervision. If symptoms persist beyond 3 days, a healthcare professional should be consulted.
Elderly
Patients Over 65 Years
No specific dose adjustment is required for elderly patients when using the lozenge or spray at the recommended doses. However, elderly individuals are at increased risk of NSAID-related adverse effects, including gastrointestinal bleeding and renal impairment. Elderly patients should use the lowest effective dose for the shortest duration possible. If you take other medications regularly, consult your doctor or pharmacist before use to check for potential interactions.
Missed Dose
Flurbiprofen STADA is used “as needed” for pain relief rather than on a fixed dosing schedule. There is no concept of a missed dose – simply use the next lozenge or spray dose when your sore throat pain returns. Ensure you maintain at least a 3-hour interval between doses and do not exceed 5 doses in any 24-hour period to compensate for a period without treatment.
Overdose
What Are the Side Effects of Flurbiprofen STADA?
Like all medicines, Flurbiprofen STADA can cause side effects, although not everybody experiences them. The locally applied low-dose formulation generally has a favourable safety profile compared to systemic NSAID tablets. In clinical trials involving flurbiprofen 8.75 mg lozenges, the overall incidence of adverse events was similar to placebo, with most reported effects being mild and transient. The side effects are categorised below by frequency, as defined by international pharmacovigilance standards.
Common
- Taste disturbance (dysgeusia) – unusual or unpleasant taste in the mouth
- Oral paraesthesia – numbness, tingling, or warming sensation in the mouth and throat
- Nausea
- Mouth ulcers or oral irritation
- Sore mouth or throat irritation at the application site
Uncommon
- Headache
- Dizziness
- Abdominal pain or discomfort
- Diarrhoea
- Dry mouth
- Bloating or flatulence
- Skin rash or itching (pruritus)
Rare
- Gastrointestinal bleeding (signs include dark or bloody stools, vomiting blood or material that looks like coffee grounds)
- Gastrointestinal ulceration
- Hypersensitivity reactions including urticaria (hives) and angioedema (swelling of face, lips, tongue, or throat)
- Bronchospasm (worsening of asthma symptoms)
- Severe skin reactions (Stevens-Johnson syndrome, erythema multiforme – extremely rare)
Not Known
- Exacerbation of colitis or Crohn’s disease in patients with existing inflammatory bowel disease
- Renal impairment (with prolonged use at higher systemic doses)
- Fluid retention and oedema (generally associated with systemic NSAID use, not topical)
The vast majority of patients who use Flurbiprofen STADA lozenges or spray at the recommended doses for the recommended duration (up to 3 days) will not experience any significant side effects. The most commonly reported effects – mild taste changes and transient oral numbness – are generally well tolerated and resolve quickly.
If you experience any side effect not listed here, or if any of the listed effects become bothersome or persistent, consult your doctor or pharmacist. You can also report suspected side effects to your national pharmacovigilance authority (such as the Yellow Card Scheme in the UK, MedWatch in the US, or the relevant agency in your country) to help monitor the safety of medicines.
How Should You Store Flurbiprofen STADA?
Proper storage of Flurbiprofen STADA ensures the product remains effective and safe throughout its shelf life. Follow these guidelines to maintain the quality of your medication:
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze the lozenges or spray solution.
- Packaging: Keep the lozenges in their original blister pack until ready to use. Store the spray bottle with the cap on when not in use. The original packaging protects the product from moisture and light.
- Children: Store all medications out of the reach and sight of children. Lozenges may look like confectionery and could be accidentally consumed by young children.
- Expiry date: Do not use the product after the expiry date (month/year) printed on the carton and blister/bottle. The expiry date refers to the last day of that month.
- Spray opening: Once the spray bottle has been opened, use within the timeframe specified by the manufacturer (typically 6 months, though check your specific product packaging).
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired medications to your pharmacy for safe disposal. This helps protect the environment.
If the lozenges show any change in appearance (such as discolouration, crumbling, or unusual odour), or if the spray solution appears cloudy or contains visible particles, do not use the product and return it to your pharmacy for replacement.
What Does Flurbiprofen STADA Contain?
Active Ingredient
The active ingredient in both formulations is flurbiprofen, a non-steroidal anti-inflammatory drug of the propionic acid class. Chemically, flurbiprofen is (RS)-2-(2-fluorobiphenyl-4-yl)propanoic acid. It is a racemic mixture, meaning it contains equal proportions of the R- and S-enantiomers. The S-enantiomer is primarily responsible for the COX-inhibiting anti-inflammatory activity, while the R-enantiomer also contributes to the analgesic effect through COX-independent mechanisms.
- Lozenge: Each lozenge contains 8.75 mg of flurbiprofen
- Oromucosal spray: Each ml of solution contains 16.2 mg of flurbiprofen. Each spray actuation delivers approximately 0.27 ml, equating to approximately 4.4 mg of flurbiprofen per spray
Inactive Ingredients (Excipients)
The excipients vary between formulations. Common inactive ingredients include:
Lozenge:
- Macrogol 300
- Potassium hydroxide
- Levomenthol
- Flavouring agents (e.g. honey-lemon, mint, or berry flavour depending on the variant)
- Sucralose (sweetener)
- Isomalt (E953)
Spray solution:
- Betadex (beta-cyclodextrin)
- Anhydrous citric acid
- Sodium hydroxide
- Methylparaben (E218, preservative)
- Flavouring agents (e.g. cherry-mint)
- Purified water
Appearance
Flurbiprofen STADA lozenges are typically round, flat tablets that are designed to dissolve slowly in the mouth. They may be off-white to light coloured, depending on the flavour variant. The oromucosal spray is a clear to slightly opalescent solution supplied in a multi-dose spray bottle with a pump mechanism and protective cap.
Frequently Asked Questions About Flurbiprofen STADA
Flurbiprofen STADA is used for the short-term symptomatic relief of sore throat pain. It is effective for pain caused by viral pharyngitis (the most common cause of sore throats), bacterial pharyngitis, tonsillitis, and general upper respiratory tract infections. The active ingredient flurbiprofen is an NSAID that reduces inflammation and pain directly in the throat tissue. It is available as 8.75 mg lozenges and as an oromucosal spray solution (16.2 mg/ml), designed for adults and adolescents over 12 years of age.
Flurbiprofen STADA typically begins to relieve sore throat pain within 15 to 30 minutes of use. In clinical trials, patients reported statistically significant pain relief compared to placebo as early as 15 minutes after dissolving a single 8.75 mg lozenge. The analgesic effect generally lasts between 4 and 6 hours per dose, making it one of the faster-acting sore throat treatments available. The spray formulation also provides rapid relief due to direct mucosal absorption.
Flurbiprofen STADA lozenges and spray are generally not recommended for children under 12 years of age due to insufficient safety and efficacy data for this age group. Adolescents aged 12 to 17 years can use the product at the same dose as adults (one lozenge or 3 sprays every 3–6 hours, maximum 5 doses per day), preferably under adult supervision. For younger children, healthcare providers typically recommend paracetamol (acetaminophen) or ibuprofen oral suspensions as safe and effective alternatives.
No, although flurbiprofen and ibuprofen are both propionic acid NSAIDs, they are different chemical compounds with distinct pharmacological properties. Flurbiprofen is considerably more potent than ibuprofen – approximately 5 to 10 times on a milligram-for-milligram basis – which is why the low dose of 8.75 mg in lozenges provides effective pain relief. Unlike standard ibuprofen tablets (200–400 mg), flurbiprofen lozenges deliver the drug directly to the inflamed throat tissue, resulting in high local concentrations but low systemic absorption. You should not use flurbiprofen lozenges and ibuprofen tablets at the same time, as combining NSAIDs increases the risk of side effects without providing additional benefit.
Flurbiprofen STADA is strictly contraindicated during the third trimester of pregnancy (from week 28 onwards) because all NSAIDs may cause premature closure of the ductus arteriosus in the fetus and inhibit uterine contractions. During the first and second trimesters, use should be avoided unless considered essential by your doctor. Regarding breastfeeding, flurbiprofen passes into breast milk in very small quantities; short-term use (up to 3 days) of the low-dose lozenge or spray is generally considered compatible with breastfeeding, but you should consult your healthcare provider before use.
Flurbiprofen STADA is intended for short-term use only, typically for a maximum of 3 consecutive days. If your sore throat symptoms have not improved after 3 days, or if they worsen at any point, you should stop using the product and consult a healthcare professional. Persistent sore throat may indicate a bacterial infection requiring antibiotics, peritonsillar abscess, or another condition that needs medical evaluation. Prolonged unsupervised NSAID use, even at low topical doses, increases the risk of adverse effects.
References
- European Medicines Agency (EMA). Flurbiprofen – Summary of Product Characteristics. Various marketing authorisation holders. Available from: EMA.
- British National Formulary (BNF). Flurbiprofen – Oropharyngeal use. NICE, 2025. Available from: BNF.
- Watson N, Nimmo WS, Christian J, et al. Relief of sore throat with the anti-inflammatory throat lozenge flurbiprofen 8.75 mg: a randomised, double-blind, placebo-controlled study of efficacy and safety. Int J Clin Pract. 2000;54(8):490–496.
- Benrimoj SI, Langford JH, Christian J, et al. Efficacy and tolerability of the anti-inflammatory throat lozenge flurbiprofen 8.75 mg in the treatment of sore throat. Clin Drug Investig. 2001;21(3):183–193.
- Schachtel B, Aspley S, Shephard A, et al. Onset of action of a lozenge containing flurbiprofen 8.75 mg: a randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity. Pain. 2014;155(2):422–428. doi:10.1016/j.pain.2013.11.001.
- NICE Clinical Knowledge Summaries. Sore throat – acute. National Institute for Health and Care Excellence, 2024. Available from: NICE CKS.
- Shephard A, Smith G, Aspley S, Schachtel BP. Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinical features of the sore throat condition in general practice. Int J Clin Pract. 2015;69(1):59–71. doi:10.1111/ijcp.12536.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Rainsford KD. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology. 2009;17(6):275–342. doi:10.1007/s10787-009-0016-x.
- Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002;133(7):861–871.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in clinical pharmacology, ENT medicine, and primary care.
Medical Content
iMedic Pharmacology Editorial Team – specialist physicians in clinical pharmacology with expertise in NSAID therapeutics and pain management
Medical Review
iMedic Medical Review Board – independent panel verifying accuracy against EMA SmPC, BNF, and NICE guidelines
Pharmacology Review
iMedic Clinical Pharmacology Team – specialists in drug interactions, pharmacokinetics, and medication safety
Accessibility & SEO
iMedic Digital Health Team – ensuring WCAG 2.2 AAA compliance and optimal search visibility
All content follows the GRADE evidence framework and is reviewed according to international medical guidelines. iMedic receives no commercial funding from pharmaceutical companies.