Flurbiprofen

Non-steroidal anti-inflammatory drug, propionic acid derivative, for topical throat treatment

ATC code: R02AX01

Brand names: Strepsils Intensive, Ansaid

Updated 24 Sep 2026 · Methodology

Indications

Sore throat

Second line

Flurbiprofen 8.75 mg is the best studied throat lozenge. The randomized trial by Watson and colleagues (Int J Clin Pract 2000) showed that the lozenge relieved sore throat markedly better than placebo, with the effect starting in the first minutes of sucking. The AEMPS ficha técnica allows the product for adults and adolescents from 12 years in short courses: the spray up to 5 applications a day at 3 to 6 hour intervals. In Spain these are Strefen and Bucopro. Flurbiprofen is a full NSAID and the systemic cautions remain: it is not used in peptic ulcer disease, severe heart failure or the third trimester of pregnancy, and bronchospasm is possible in asthma. The ficha also warns about something rare but important: if signs of bacterial infection appear or worsen during treatment, urgent assessment is needed – cases of necrotizing fasciitis have been reported.

Sources

ICD-10: R07.0

Streptococcal pharyngitis

Adjunct

A flurbiprofen lozenge is often used instead of a doctor's visit when the throat hurts badly and there is exudate. It has no antimicrobial action: flurbiprofen relieves pain and inflammation while group A streptococcus stays. Worse, the ficha técnica warns directly that an NSAID in this setting masks a developing bacterial infection, and names cases of necrotizing fasciitis during treatment. When streptococcal tonsillopharyngitis is suspected, the decision rests on examination and a rapid test: some patients need an antibiotic, others are not prescribed one, and the analgesic is an add-on here. The rule of thumb is simple: pain worse than an ordinary cold, fever above 38, tonsillar exudate, enlarged neck nodes and no cough – that is a reason to see a doctor rather than buy another pack of lozenges.

Sources

AEMPS: Ficha técnica de flurbiprofeno (2023)

ICD-10: J02.0 · ICD-11: 1B51

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Common cold

Not recommended

The «cold remedy» positioning of flurbiprofen lozenges rests on a feeling: the throat stopped hurting, so treatment must be working. The product does not affect the duration of a cold. The 2014 Cochrane review of over-the-counter cough medicines found no convincing data in favor of pharmacy cold remedies in adults or children, and the Spanish Guía-ABE chapter on upper respiratory catarrh states plainly that no such drug provides meaningful symptom relief. There is also an age limit: throat flurbiprofen is contraindicated in children under 12. A cold resolves in 5 to 10 days and no lozenge speeds that up – it is there precisely to make the pain easier to bear. If flurbiprofen was recommended as a course «so you do not fall ill», consider seeking a second opinion.

Sources

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

A propionic acid derivative, a relative of ibuprofen and ketoprofen. It blocks cyclooxygenase and cuts off the synthesis of prostaglandins that make inflamed throat mucosa hurt and swell. The AEMPS ficha técnica gives the specifics: a dose of 8.75 mg dissolved in artificial saliva reduces prostaglandin synthesis in cultured human respiratory cells. In a lozenge or spray the substance stays on the mucosa where the effect is needed, but part of the dose is absorbed, and the systemic properties of an NSAID do not disappear – hence the warnings about the stomach, blood pressure and asthma. That is why the short course is not a formality here: in Spain throat flurbiprofen is allowed for adults and adolescents from 12 years, at most 5 applications a day, and not as a standing remedy.

Safety

Contraindications

Hypersensitivity to flurbiprofen, acetylsalicylic acid or other NSAIDs
Past bronchospasm, urticaria or rhinitis in response to acetylsalicylic acid or other NSAIDs
Active peptic ulcer or gastrointestinal bleeding
Severe heart failure
Third trimester of pregnancy
Children under 12 years

Serious adverse effects

Anaphylaxis and other severe hypersensitivity reactions
Bronchospasm and worsening of asthma
Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome and toxic epidermal necrolysis
Worsening of infectious inflammation, with reported cases of necrotizing fasciitis
Gastrointestinal bleeding

Common adverse effects

Irritation and numbness of the mouth and throat lining
Taste disturbance
Dry mouth
Dizziness and headache
Nausea, diarrhea, abdominal pain

Pregnancy: can you take Flurbiprofen?

NSAIDs are contraindicated in the third trimester: they close the fetal ductus arteriosus, depress the kidneys, prolong bleeding time and delay delivery. In the first and second trimesters throat flurbiprofen is used only when nothing else will do, and for the shortest possible time.

Breastfeeding: can you take Flurbiprofen?

Flurbiprofen passes into breast milk in small amounts. It is not used while breastfeeding because safety for the infant has not been established.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions22 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

MajorAcetylsalicylic acid
«Ácido acetilsalicílico (dosis bajas): El flurbiprofeno debe emplearse con precaución en combinación con:»
AEMPS, section 4.5 · Open on CIMA
MajorAINEclass named in the label
«Mifepristona: Como los AINEs pueden reducir el efecto de la mifepristona, no deben utilizarse en los 8-12 días posteriores a la administración de la mifepristona.»
AEMPS, section 4.5 · Open on CIMA
MajorMifepristone
«Mifepristona: Como los AINEs pueden reducir el efecto de la mifepristona, no deben utilizarse en los 8-12 días posteriores a la administración de la mifepristona.»
AEMPS, section 4.5 · Open on CIMA
Moderateantiagregantesclass named in the label
«Efectos gastrointestinales: Debe aconsejarse precaución en los pacientes que reciban medicamentos concomitantes que puedan aumentar el riesgo de ulceración o hemorragia, como corticosteroides orales…»
AEMPS, section 4.4 · Open on CIMA
Moderateanticoagulantesclass named in the label
«Efectos gastrointestinales: Debe aconsejarse precaución en los pacientes que reciban medicamentos concomitantes que puedan aumentar el riesgo de ulceración o hemorragia, como corticosteroides orales…»
AEMPS, section 4.4 · Open on CIMA
Moderatecorticosteroidesclass named in the label
«Efectos gastrointestinales: Debe aconsejarse precaución en los pacientes que reciban medicamentos concomitantes que puedan aumentar el riesgo de ulceración o hemorragia, como corticosteroides orales…»
AEMPS, section 4.4 · Open on CIMA
Moderatedigitálicosclass named in the label
«Glucósidos cardíacos: Los AINEs pueden exacerbar la insuficiencia cardíaca, reducir la tasa de filtración glomerular y aumentar los niveles de glucósidos plasmáticos; se recomienda un control…»
AEMPS, section 4.5 · Open on CIMA
ModerateISRSclass named in the label
«Efectos gastrointestinales: Debe aconsejarse precaución en los pacientes que reciban medicamentos concomitantes que puedan aumentar el riesgo de ulceración o hemorragia, como corticosteroides orales…»
AEMPS, section 4.4 · Open on CIMA
ModerateLithium
«Litio: Puede aumentar los niveles séricos de litio; se recomienda un control adecuado y, en caso necesario, un ajuste de la dosis.»
AEMPS, section 4.5 · Open on CIMA
ModeratePhenytoin
«Fenitoína: Puede aumentar los niveles séricos de fenitoína; se recomienda un control adecuado y, en caso necesario, un ajuste de la dosis.»
AEMPS, section 4.5 · Open on CIMA
ModerateWarfarin
«Efectos gastrointestinales: Debe aconsejarse precaución en los pacientes que reciban medicamentos concomitantes que puedan aumentar el riesgo de ulceración o hemorragia, como corticosteroides orales…»
AEMPS, section 4.4 · Open on CIMA
antidiabéticosclass named in the label
«Antidiabéticos orales: Se han notificado alteración de los niveles sanguíneos de glucosa (se recomienda comprobar los niveles de forma más frecuente).»
AEMPS, section 4.5 · Open on CIMA
antidiabéticos oralesclass named in the label
«Antidiabéticos orales: Se han notificado alteración de los niveles sanguíneos de glucosa (se recomienda comprobar los niveles de forma más frecuente).»
AEMPS, section 4.5 · Open on CIMA
Ciclosporin
«Ciclosporina: Aumento del riesgo de nefrotoxicidad.»
AEMPS, section 4.5 · Open on CIMA
diuréticosclass named in the label
«Fármacos antihipertensores (diuréticos, IECA, antagonistas de la angiotensina II)»
AEMPS, section 4.5 · Open on CIMA
diuréticos ahorradores de potasioclass named in the label
«Diuréticos ahorradores de potasio: El uso concomitante puede causar hiperpotasemia.»
AEMPS, section 4.5 · Open on CIMA
inhibidores de la ECAclass named in the label
«Fármacos antihipertensores (diuréticos, IECA, antagonistas de la angiotensina II)»
AEMPS, section 4.5 · Open on CIMA
Methotrexate
«Metotrexato: La administración de AINEs en las 24 horas previas o posteriores a la administración de metotrexato puede elevar las concentraciones de este fármaco y aumentar sus efectos tóxicos.»
AEMPS, section 4.5 · Open on CIMA
quinolonasclass named in the label
«Antibióticos quinolonas: Los datos obtenidos en animales sugieren que los AINEs pueden aumentar el riesgo de convulsiones asociadas a las quinolonas. Los pacientes que toman AINEs y quinolonas pueden…»
AEMPS, section 4.5 · Open on CIMA
Tacrolimus
«Tacrolimus: Posible aumento del riesgo de nefrotoxicidad cuando los AINEs se administran con tacrolimus.»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

Eltrombopag
«Sustratos del citocromo P450: La administración de 75 mg de eltrombopag una vez al día, durante 7 días, a 24 varones sanos, no inhibió o indujo el metabolismo de los sustratos de investigación para…»
AEMPS, section 4.5 · Open on CIMA
Fluconazole
«Antiinflamatorios no esteroideos (AINEs): La C máx y el AUC de flurbiprofeno aumentaron un 23% y un 81% respectivamente cuando se administra concomitantemente con fluconazol, comparado con la…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Flurbiprofen used for?

Flurbiprofen is evaluated for the following indications with varying evidence strength: Sore throat (evidence tier B), Streptococcal pharyngitis (evidence tier D), Common cold (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Flurbiprofen?

Common side effects of Flurbiprofen (≥ 1 in 100): Irritation and numbness of the mouth and throat lining, Taste disturbance, Dry mouth, Dizziness and headache, Nausea, diarrhea, abdominal pain. See the Safety section for uncommon and serious reactions.

Is Flurbiprofen safe during pregnancy?

Is Flurbiprofen compatible with breastfeeding?

Flurbiprofen passes into breast milk in small amounts. It is not used while breastfeeding because safety for the infant has not been established.

Who should not take Flurbiprofen?

Flurbiprofen is contraindicated in: Hypersensitivity to flurbiprofen, acetylsalicylic acid or other NSAIDs; Past bronchospasm, urticaria or rhinitis in response to acetylsalicylic acid or other NSAIDs; Active peptic ulcer or gastrointestinal bleeding; Severe heart failure; Third trimester of pregnancy. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 08/17/2026

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