Myotropic antispasmodics
ATC code: A03AD02 (Drotaverine)
Inhibits phosphodiesterase 4 (PDE-4) in smooth muscle. Reduces intracellular calcium concentration and causes relaxation of smooth muscles in the GI tract, biliary system, urinary tract, and uterus. Does not affect skeletal muscles and has no anticholinergic activity.
Adjunct
Symptomatic relief of abdominal smooth muscle spasm – intestinal colic, biliary colic, renal colic. Does not address the underlying cause. Drotaverine is not mentioned in international guidelines by , , or . The evidence base is limited to older, low-quality studies. Widely used in Russia and CIS countries.
Adjunct
Adjunctive agent for dysmenorrhea. First-line is NSAIDs (ibuprofen, naproxen), which suppress prostaglandin synthesis. Drotaverine relieves uterine spasm but does not affect inflammation. Several small RCTs showed pain relief, but study quality was low.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Drotaverine is widely prescribed for PMS pain, any abdominal spasm, biliary dyskinesia and labor analgesia. NG121 and 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.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Safety data in pregnancy are limited. In Russian practice, it is used for threatened abortion to reduce uterine tone. This use is not described in international guidelines.
Drotaverine (No-Spa) has no AEMPS registration. Developed in Hungary, the drug remains a common antispasmodic in Russia and CIS countries. No data exist on transfer into human milk; Hale has not assigned a category. AEG favours mebeverine or hyoscine butylbromide as antispasmodics for intestinal colic and IBS, and does not back drotaverine as a first-line option in breastfeeding mothers.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Drotaverine is evaluated for the following indications with varying evidence strength: Dysmenorrhea (evidence tier B), Abdominal smooth muscle spasm (evidence tier B), Biliary dyskinesia (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Drotaverine (≥ 1 in 100): Headache, Dizziness, Nausea, Hypotension. See the Safety section for uncommon and serious reactions.
FDA category C. Safety data in pregnancy are limited. In Russian practice, it is used for threatened abortion to reduce uterine tone. This use is not described in international guidelines.
Drotaverine (No-Spa) has no AEMPS registration. Developed in Hungary, the drug remains a common antispasmodic in Russia and CIS countries. No data exist on transfer into human milk; Hale has not assigned a category. AEG favours mebeverine or hyoscine butylbromide as antispasmodics for intestinal colic and IBS, and does not back drotaverine as a first-line option in breastfeeding mothers.
Drotaverine is contraindicated in: Severe hepatic or renal insufficiency; Severe heart failure (low cardiac output syndrome); Hypersensitivity to drotaverine; Breastfeeding (insufficient data). Full list in the Safety section.