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Benzydamine

AEMPS

Non-steroidal anti-inflammatory agent for topical use in the mouth and throat

ATC code: R02AX03

Brand names: Difflam

Updated · Methodology

Indications

B

Sore throat

Second line

Benzydamine is a topical anti-inflammatory for the throat. The AEMPS ficha técnica gives it a single indication: symptomatic treatment of acute sore throat in adults and children over 6 years, for no longer than 7 days and one lozenge three times a day. The effect is local: the substance accumulates in inflamed mucosa and removes pain and redness while the viral infection runs its course. A 2018 meta-analysis in Anaesthesia confirms the same mechanism from the operating room side: benzydamine gargling before intubation reduced the rate of sore throat after anesthesia. Spanish pharmacies sell it as Propalgar, Fodonal, Juanolgar and Tantum Verde. Three limits from the ficha are worth knowing in advance: benzydamine is unsuitable with salicylate or NSAID allergy, bronchospasm is possible in people with asthma, and if pain lasts beyond 3 days or high fever appears, the situation needs reassessment.

Sources

  1. AEMPS: Ficha técnica de bencidamina (2024)
  2. Anaesthesia: Topical benzydamine hydrochloride for prevention of postoperative sore throat: a systematic review and meta-analysis (2018)

ICD-10: R07.0

D

Streptococcal pharyngitis

Adjunct

Benzydamine is often bought «for tonsillitis», with the lozenge taken as a substitute for an antibiotic. It does not work that way. Benzydamine relieves pain and mucosal inflammation, it has no action against group A streptococcus, and the AEMPS ficha técnica ascribes no antimicrobial activity to it. In confirmed streptococcal tonsillopharyngitis the antibiotic decision rests on the clinical picture and a rapid test, while the lozenge remains pain relief on top. The ficha warns separately about the trap: in some patients an ulcer in the mouth or throat signals serious disease, and once symptoms fail to clear in 3 days or fever rises, self-treatment should stop. The danger lies in the delay: while pain is muffled by a lozenge, untreated streptococcus produces peritonsillar abscess and rheumatic fever. If lozenges were offered as treatment for tonsillitis instead of an examination, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de bencidamina (2024)

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.

D

Common cold

Not recommended

Throat lozenge advertising promises to «beat the cold faster». Benzydamine does not shorten a cold. It relieves throat pain, while the runny nose, cough, fever and general wipe-out run their course: a viral upper respiratory infection lasts 5 to 10 days whether or not lozenges are sucked. The 2014 Cochrane review of over-the-counter cough medicines and the 2015 review of antihistamines for the common cold show the same thing – pharmacy cold remedies either have no effect or one so small that the patient does not notice it. In pediatrics, Spanish authors in Anales de Pediatría 2022 described the other side: cold remedies cause poisonings and show no benefit in children. Sensible management of a cold is simple – fluids, rest, paracetamol or ibuprofen as needed. If lozenges are sold as a way to «cure a cold in three days», consider seeking a second opinion.

Sources

  1. Cochrane: Over-the-counter (OTC) medications for acute cough in children and adults in community settings (2014)
  2. Cochrane: Antihistamines for the common cold (2015)
  3. Anales de Pediatria: Intoxicacion no intencionada por anticatarrales: medicamentos poco utiles y potencialmente toxicos (2022)

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

An indazole derivative, chemically unlike classic NSAIDs yet acting the same way: it suppresses prostaglandin synthesis and removes local signs of inflammation – pain, redness, swelling. Benzydamine also has a moderate local anesthetic effect and stabilizes cell membranes. The molecule penetrates inflamed mucosa well and accumulates exactly where inflammation runs, so a lozenge or spray works at the site of application. It is absorbed through the mouth and throat lining and can be measured in plasma, but the concentrations stay far below those needed for systemic action. Elimination is mainly renal, largely as metabolites and conjugates.

Safety

Contraindications

  • Hypersensitivity to benzydamine
  • Children under 6 years because of the dosage form
  • Caution with hypersensitivity to salicylates and other NSAIDs

Serious adverse effects

  • Bronchospasm in people with asthma
  • Laryngospasm
  • Anaphylactic reactions
  • Angioedema

Common adverse effects

  • Burning and numbness in the mouth
  • Dry mouth
  • Nausea
  • Unpleasant taste

Pregnancy: can you take Benzydamine?

There are no clinical data on use in pregnancy. In the third trimester systemic prostaglandin synthesis inhibitors cause fetal cardiopulmonary and renal toxicity, and late in pregnancy they prolong bleeding time in mother and child and delay delivery. Whether benzydamine is absorbed from mucosa in amounts dangerous to the fetus is unknown, so it is not used during pregnancy.

Breastfeeding: can you take Benzydamine?

Whether benzydamine passes into breast milk has not been studied and a risk to the infant cannot be excluded. It is not used while breastfeeding.

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

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Frequently asked

What is Benzydamine used for?

Benzydamine 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 Benzydamine?

Common side effects of Benzydamine (≥ 1 in 100): Burning and numbness in the mouth, Dry mouth, Nausea, Unpleasant taste. See the Safety section for uncommon and serious reactions.

Is Benzydamine safe during pregnancy?

There are no clinical data on use in pregnancy. In the third trimester systemic prostaglandin synthesis inhibitors cause fetal cardiopulmonary and renal toxicity, and late in pregnancy they prolong bleeding time in mother and child and delay delivery. Whether benzydamine is absorbed from mucosa in amounts dangerous to the fetus is unknown, so it is not used during pregnancy.

Is Benzydamine compatible with breastfeeding?

Whether benzydamine passes into breast milk has not been studied and a risk to the infant cannot be excluded. It is not used while breastfeeding.

Who should not take Benzydamine?

Benzydamine is contraindicated in: Hypersensitivity to benzydamine; Children under 6 years because of the dosage form; Caution with hypersensitivity to salicylates and other NSAIDs. Full list in the Safety section.

Official sources

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