Commonside effects with the inhaled form includerespiratory infections, cough, and headaches.[16] Common side effects with the pills include feeling tired, vomiting, andjoint pains.[16] Serious side effects include an increased risk of infection, loss of bone strength, andcataracts.[16] Long-term use of the pill form may causeadrenal insufficiency.[16] Stopping the pills suddenly following long-term use may therefore be dangerous.[16] The inhaled form is generally safe inpregnancy.[16] Budesonide chiefly acts as aglucocorticoid.[16]
Budesonide is given bymetered-dose inhaler ornebulizer for maintenance and prophylactic treatment ofasthma, including patients who require oralcorticosteroids and those who may benefit from a systemic dose reduction.[24]
Formulations of delayed-release budesonide are an effective treatment for mild-to-moderately activeCrohn's disease involving theileum and/orascending colon.[25] ACochrane review found evidence for up to three months (but not longer) of maintenance of remission in Crohn's disease, concluding that budesonide is not effective for maintenance of remission in CD.[26]
Topical budesonide has considerable effects ineosinophilic esophagitis.[31] For this use, it is formulated as a tablet thatdisperses in the mouth, and sold under the brand name Jorveza.[32]
Budesonide (Tarpeyo (US); Kinpeygo (EU, UK)) is indicated to reduce proteinuria (increased protein levels in the urine) in adults with primaryimmunoglobulin A (IgA) nephropathy (Berger's disease) at risk of rapid disease progression.[3][33][7]
Nasal budesonide inhalers have been associated with a number of side effects.[34][35] These include nose irritation or burning, bleeding or sores in the nose, lightheadedness, upset stomach, cough, hoarseness, dry mouth, rash, sore throat,bad taste in mouth, change inmucus, and blurred vision.[36] Other symptoms which should be reported immediately include difficulty in breathing, swelling of the face, white patches in the throat, mouth, or nose, irregularmenstrual periods, severe acne, and on rare occasions, behavioral changes (mostly affecting children).[34]
Acute toxicity from an overdose of Budesonide is significantly more rare than an overdosing of budesonide over a prolonged period of therapy, however both can can cause systemic toxicity that manifests ashypercortisolism.[37] Symptoms of an overdose include more specific symptoms such as darkening and thinning of the skin, changes in body fat around the face, neck, back, and waist, increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex, as well as some less specific symptoms such as diarrhea, dizziness, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.[38][39]
Budesonide is mainly metabolized in the liver by the enzymeCYP3A4.[37][42] Drugs that areCYP3A4 inhibitors such asketoconazole,clarithromycin,ritonavir, andnefazodone, among many others, may inhibit the metabolism of Budesonide, prolonging its elimination and leading to possible increased rates of corticosteroid adverse effects due to unwanted drug accumulation.[37][43]Grapefruit is also a potent inhibitor of CYP3A4, and therefore its consumption is not recommended while on budesonide treatment.[37][44]
Different pharmacokinetic proprieties can be seen in the absorption of budesonide depending on how it is formulated. When taken as an extended-release oral capsule, budesonide has an oralbioavailability of 9–21% and reachespeak plasma concentrations (Cmax) within 2–8 hours.[48] A high fat meal when taken with the capsule can lengthen the time it takes to reach Cmax by another 2.3 hours, but will not have any other affects on the pharmacokinetics properties of budesonide.[49] When inhaled through an metered dose inhaler, 34% of budesonide is deposited in the lung with abioavailability of 39% and reaches Cmax within 10 minutes.[49][50] When nebulized, budesonide has anbioavailability of 6% and reaches Cmax within 1–3 hours.[50][49] When formulated as a rectal foam, budesonide has anbioavailability of 3% to 27% and reaches Cmax around 1.5 hours.[51]
In 2019, 44 US states filed a lawsuit claiming that leading drug companies includingTeva, Pfizer, Novartis and Mylanconspired to inflate the prices of over a hundred generic drugs, including budesonide, as much as tenfold.[59]
Kinpeygo, a hybrid medicine of Entocort (which has been authorised in the EU since 2 April 1992) that contains the same active substance as Entocort but has a different formulation and a different indication,[60] was approved for medical use in the European Union in July 2022.[7][61]
Budesonide was recommended in April 2021 by the UK's NHS to treat COVID-19 on a case-by-case basis for those aged 50 years of age and older.[63] After aUniversity of Oxford research team found in a trial with 1,700 patients that budesonide could benefit many people over 50 withCOVID-19 symptoms, it was recommended from 12 April 2021, by theNational Health Service in the UK forgeneral practitioners (GPs) to treat COVID-19 on a case-by-case basis.[64][65] Results of a large-scale trial published in August 2021 suggest that inhaled budesonide improves the time of recovery and people's well-being during the recovery process.[66][67] Inhalational budesonide was added to the recommended treatment for cases of COVID-19 inIndia in April 2021.[68][69] The NIH recommendation was withdrawn in December 2021 citing the need for more research.[70][71]
^Rudmik L, Schlosser RJ, Smith TL, Soler ZM (July 2012). "Impact of topical nasal steroid therapy on symptoms of nasal polyposis: a meta-analysis".The Laryngoscope.122 (7):1431–7.doi:10.1002/lary.23259.PMID22410935.S2CID25637461.
^Silverman J, Otley A (July 2011). "Budesonide in the treatment of inflammatory bowel disease".Expert Review of Clinical Immunology.7 (4):419–28.doi:10.1586/eci.11.34.PMID21790284.S2CID32892611.
^Pardi DS, Tremaine WJ, Carrasco-Labra A (January 2016). "American Gastroenterological Association Institute Technical Review on the Medical Management of Microscopic Colitis".Gastroenterology.150 (1): 247–274.e11.doi:10.1053/j.gastro.2015.11.006.PMID26584602.
^British national formulary: BNF 58 (58 ed.). British Medical Association. 2009. pp. 56–57.ISBN9780857111562.
^abcdefg"Budesonide". The American Society of Health-System Pharmacists.Archived from the original on 28 November 2015. Retrieved2 December 2015.
^World Health Organization (2019).World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization.hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^Hamilton R (2015).Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 451.ISBN9781284057560.
^Pardi DS, Tremaine WJ, Carrasco-Labra A (January 2016). "American Gastroenterological Association Institute Technical Review on the Medical Management of Microscopic Colitis".Gastroenterology.150 (1): 247–274.e11.doi:10.1053/j.gastro.2015.11.006.PMID26584602.
^"Kinpeygo: Pending EC decision".European Medicines Agency (EMA). 20 May 2022.Archived from the original on 20 May 2022. Retrieved20 May 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"Kinpeygo Product information".Union Register of medicinal products. EU/1/22/1657.Archived from the original on 4 March 2023. Retrieved3 March 2023. With cumulative list of related EU decisions.
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