Herbal medicinal products for respiratory infections in the pediatric population
Abstract
Cough and cold represent some of the most prevalent indications for using herbal medicinal products in pediatric care across European countries. These herbal medicines are generally regarded as safe, with their efficacy predominantly classified as good to very good. Traditional herbal medicinal products based on mucilaginous herbal drugs like Althaeae radix, Malvae folium, Lichen islandicus and Plantaginis lanceolatae folium are used in the treatment of oral and pharyngeal inflammations and associated dry cough. For productive coughs, herbal medicinal products with well-established use, based on Hederae folium, or a range of traditional herbal medicinal products containing Primulae radix, Thymi herba, and other aromatic drugs and essential oils are administered. It is important to note that products containing essential oils and certain aromatic herbal drugs are contraindicated in children under 2 to 2.5 years of age due to the risk of laryngospasm. In the pediatric population, products derived from Matricariae flos, Pelargonii radix, Tiliae flos and Sambuci flos are used to relieve various cold symptoms. Use is restricted to children over a certain age, mostly due to lack of safety data, and in some cases due to the possibility of certain adverse effects.
References
Schrier L, Hadjipanayis A, Stiris T, Ross-Russell R, Valiulis A, Turner M, et al. Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology. Eur J Pediatr. 2020;179:839–47.
Ullah H, De Filippis A, Baldi A, Dacrema M, Esposito C, Garzarella EU, et al. Beneficial Effects of Plant Extracts and Bioactive Food Components in Childhood Supplementation. Nutrients. 2021;13:3157.
Kundaković T, Maksimović Z. Phytotherapy of acute upper respiratory tract infections in children. Arh farm. 2022;72:320–39.
Nieber K, Raskopf E, Möller J, Kelber O, Fürst R, Shah-Hosseini K, et al. Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study. Eur J Pediatr. 2020;179(3):507–12.
Hensel A, Bauer R, Heinrich M, Hempel G, Kelber O, Kraft K, et al. Rationalising Optimal Dosing of Phytotherapeutics For Use In Children: Current Status - Potential Solutions - Actions Needed. Planta Med. 2024;90(6):416–25. doi: 10.1055/a-2294-5259.
Güemes Heras I, Santamaría-Orleans A, Colinas Herrero JF, Gómez Sorrigueta P, Ortiz González L, Iglesia-Arnaez R, Canals Baeza A. Use of Dietary Supplements among Spanish Pediatricians in Daily Practice: A Cross-Sectional Survey Study. J Nutr Metab. 2019:5819305. doi: 10.1155/2019/5819305.
Permanand G, Mossialos E, McKee M. The EU's new paediatric medicines legislation: serving children's needs? Arch Dis Child. 2007;92(9):808–11.
Marquardt P, Kaft K, Nieber K. Clinical trials with herbal medicinal products in children: a literature analysis. Wien Med Wochenschr. 2015;165:236–42.
Hensel A, Bauer R, Heinrich M, Kraft K. Consensus Statement on the Outcome of a Workshop on Paediatric Phytotherapy: Rationalising Optimal Dosing for Use in Children by Real-World Data. Planta Med. 2023;89(15):1442–3.
Farrington R, Musgrave I, Byard R. Potential adverse outcomes of herbal preparation use in childhood. Acta Paediatr. 2019;108(3):419–22.
Gardiner P, Adams D, Filippelli AC, Nasser H, Saper R, White L, Vohra S. A systematic review of the reporting of adverse events associated with medical herb use among children. Glob Adv Health Med. 2013;2(2):46–55.
Medicines [Internet]. European Medicines Agency; 2025 [cited 2025 Aug 22]. Available from: https://www.ema.europa.eu/en/medicines.
Petrović S, Maksimović Z. Biljni lekovi za respiratorna oboljenja kod dece. Arh. Farm. 2005;55:410–9.
European Medicines Agency. EMA/HMPC/436680/2015. Assessment report on Althaea officinalis L., radix. London, 2016.
European Medicines Agency. EMA/HMPC/436679/2015. European Union herbal monograph on Althaea officinalis L., radix. London, 2016.
European Medicines Agency. EMA/HMPC/749518/2016. Assessment report on Malva sylvestris L. and/or Malva neglecta Wallr., folium and Malva sylvestris L., flos. Amsterdam, 2018.
European Medicines Agency. EMA/HMPC/749511/2016. European Union herbal monograph on Malva sylvestris L., flos, London, 2018.
European Medicines Agency. EMA/HMPC/749510/2016. European Union herbal monograph on Malva sylvestris L. and/or Malva neglecta Wallr., folium. Amsterdam, 2018.
European Medicines Agency. EMA/HMPC/36866/2014. Assessment report on Cetraria islandica (L.) Acharius s.l., thallus. London, 2014.
European Medicines Agency. EMA/HMPC/678891/2013. European Union herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus. London, 2014.
European Medicines Agency. EMA/HMPC/887981/2022. Assessment report on Plantago lanceolata L., folium (Draft – revision 1). Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/887979/2022. European Union herbal monograph on Plantago lanceolata L., folium (Draft – revision 1). Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/55837/2011. Assessment report on Matricaria recutita L., flos and Matricaria recutita L., aetheroleum. London, 2015.
European Medicines Agency. EMA/HMPC/55843/2011. European Union herbal monograph on Matricaria recutita L., flos. London, 2015.
European Medicines Agency. EMA/HMPC/437450/2017. European Union herbal monograph on Calendula officinalis L., flos. London, 2018.
European Medicines Agency. EMA/HMPC/680597/2013. European Union herbal monograph on Agrimonia eupatoria L., herba. London, 2005.
European Medicines Agency. EMA/HMPC/143658/2015. European Union herbal monograph on Polygonum aviculare L., herba. London, 2016.
European Medicines Agency. EMA/HMPC/280193/2013. European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba. London, 2014.
European Medicines Agency. EMA/HMPC/280194/2013. Assessment report on Sisymbrium officinale (L.) Scop., herba. London, 2014.
Sticher O, Heilmann J, Zündorf I. Hänsel / Sticher Pharmacognosie Phytotherapy. 10th ed. Stuttgart: Wissenschaftliche Verlagsgesellschaft; 2015; pp. 610, 709.
European Medicines Agency. EMA/HMPC/325716/2017. European Union herbal monograph on Hedera helix L., folium. London, 2017.
European Medicines Agency. EMA/HMPC/104095/2012. Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, radix. London, 2012.
European Medicines Agency. EMA/HMPC/136582/2012. Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos. London, 2012.
European Medicines Agency. EMA/HMPC/84990/2015 Corr. European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or Primula elatior (L.) Hill, radix. London, 2016.
European Medicines Agency. EMA/HMPC/325715/2017. Assessment report on Hedera helix L., folium. London, 2017.
European Medicines Agency. EMA/HMPC/113577/2012. Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, radix. London, 2012.
European Medicines Agency. EMA/HMPC/136583/2012. Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, flos. London, 2012.
Tucakov J. Lečenje biljem. Beograd: Rad; 1990; pp. 304–5.
European Medicines Agency. EMA/HMPC/611531/2016. Assessment report on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. London, 2018.
European Medicines Agency. EMA/HMPC/611537/2016. European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. London, 2018.
European Pharmacopoeia. 11th Edition, Strasbourg: Council of Europe, 2022.
European Medicines Agency. EMA/HMPC/342334/2013. Assessment report on Thymus vulgaris L. and Thymus zygis L., herba. London, 2013.
European Medicines Agency. EMA/HMPC/342332/2013. Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba. London, 2013.
European Medicines Agency. EMA/HMPC/59032/2017. European Union herbal monograph on Thymus vulgaris L., Thymus zygis L., aetheroleum. Amsterdam, 2020.
Drobac M, Arsenijević J, Marčetić M. Bezbednosni aspekti primene biljnih proizvoda koji sadrže jedinjenja sa potencijalnim rizikom. Arh farm. 2019;69(4):307–21.
European Medicines Agency. EMA/HMPC/522456/2021. Public statement on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum. Amsterdam, 2024.
European Medicines Agency. EMEA/HMPC/321181/2012. Assessment report on Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum; European Medicines Agency. London, 2013.
European Medicines Agency. EMA/HMPC/321184/2012. Community herbal monograph on Pimpinella anisum L., fructus. London, 2013.
European Medicines Agency. EMEA/HMPC/372839/2016. European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab., fructus. Revision 1. Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/372841/2016. European Union herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus. Revision 1. Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/892618/2011. Community herbal monograph on Eucalyptus globulus Labill., folium. London, 2013.
European Medicines Agency. EMA/HMPC/320292/2023. European Union herbal monograph on Eucalyptus globulus Labill.; Eucalyptus polybractea R.T. Baker; Eucalyptus smithii R.T. Baker, aetheroleum. Revision 1. Amsterdam, 2024.
Plevkova J, Kollarik M, Poliacek I, Brozmanova M, Surdenikova L, Tatar M, et al. The role of trigeminal nasal TRPM8-expressing afferent neurons in the antitussive effects of menthol. J Appl Physiol. 2013;115(2):268–74.
European Medicines Agency. EMA/HMPC/138386/2005 Rev. 1. Public statement on the use of herbal medicinal products1 containing pulegone and menthofuran. London, 2016.
European Medicines Agency. EMA/HMPC/522410/2013. European Union herbal monograph on Mentha x piperita L., aetheroleum. Revision 1. Amsterdam, 2020.
European Medicines Agency. EMA/HMPC/48704/2014 Corr 1European Union herbal monograph on Echinacea purpurea (L.) Moench, herba recens. London, 2015.
European Medicines Agency. EMA/HMPC/688216/2008. Community herbal monograph on Echinacea angustifolia DC., radix. London, 2012.
European Medicines Agency. EMA/HMPC/737380/2018. European Union herbal monograph on Echinacea pallida (Nutt.) Nutt., radix. London, 2018.
European Medicines Agency. EMA/HMPC/648100/2022. European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix. Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/765656/2022. Assessment report on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix. Amsterdam, 2024.
European Medicines Agency. EMA/HMPC/337066/2011. Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos. London, 2012.
European Medicines Agency. EMA/HMPC/611512/2016. European Union herbal monograph on Sambucus nigra L., flos. London, 2018.
