Biliary dyskinesia
ICD-10 K82.84 drugs
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.
- DMebeverineNot recommended · Antispasmodics (myotropic)Mebeverine is an antispasmodic that relaxes the smooth muscle of the gut, and it's sometimes prescribed for biliary dyskinesia too. Convincing benefit for this particular condition hasn't been shown, and there's no solid evidence base for the use. Gallbladder and sphincter dysfunction usually calls for clarifying the diagnosis, adjusting diet, and follow-up with a gastroenterologist who can match the approach to the actual cause of symptoms.
- FDrotaverineNot recommended · Myotropic antispasmodicsDrotaverine is widely prescribed for PMS pain, any abdominal spasm, biliary dyskinesia and labor analgesia. NICE NG121 and AGA 2022 do not describe drotaverine in functional GI standards. Cochrane analyses on IBS and abdominal pain do not support drotaverine. Drotaverine is not registered in the US and most of the EU.
- FHyoscine butylbromideNot recommended · Antispasmodic, quaternary ammonium belladonna alkaloidHyoscine butylbromide is prescribed for any abdominal discomfort and stress-related PMS spasm. NICE NG121 and AGA 2022 confine hyoscine to confirmed functional GI spasm disorders. Long-term use causes anticholinergic effects (dry mouth, tachycardia, urinary retention, glaucoma worsening).
- FOtilonium bromideNot recommended · Intestinal antispasmodic, quaternary ammonium compoundOtilonium bromide is an antimuscarinic and calcium-blocking spasmolytic with local action in the gut. It is prescribed for irritable bowel syndrome and GI smooth muscle spasms (AEMPS Ficha Técnica). For biliary dyskinesia, otilonium bromide is occasionally prescribed in Russia and the CIS. Biliary dyskinesia as an independent diagnosis is rarely used in international medicine – more often functional gallbladder and sphincter of Oddi disorders are differentiated per Rome IV criteria. In people with ordinary right-upper-quadrant discomfort without confirmed biliary pathology, otilonium bromide is not indicated. The drug is relatively safe but can cause dry mouth, blurred vision, palpitations, and allergic reactions. If otilonium bromide was prescribed for biliary dyskinesia, consider seeking a second opinion.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- 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