Drotaverine

Myotropic antispasmodics

ATC code: A03AD02 (Drotaverine)

Mechanism of action

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.

Indications

Dysmenorrhea

Second line

Adjunct for dysmenorrhea. First-line is NSAIDs (ibuprofen, naproxen), which suppress prostaglandin synthesis. Drotaverine relieves uterine spasm but does not affect inflammation. A few small RCTs showed pain relief, but their quality is low. International guidelines do not list drotaverine for dysmenorrhea; it is popular in Russia and several regions.

Sources

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.

Abdominal smooth muscle spasm

Not recommended

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.

Sources

Biliary dyskinesia

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.

Sources

Practical notes

Timing and administration

Take 40–80 mg 2–3 times daily. Maximum daily dose 240 mg. May be taken regardless of food. Onset of action is 15–20 minutes orally. Intramuscular injection works within 5–10 minutes.

Special situations

Not included in international guidelines (, ). Popular in Russia and CIS but virtually unused elsewhere. Few high-quality independent studies exist. In severe abdominal pain, it is important not to mask 'acute abdomen' symptoms – rule out surgical pathology before prescribing an antispasmodic.

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Safety

Contraindications

Severe hepatic or renal insufficiency
Severe heart failure (low cardiac output syndrome)
Hypersensitivity to drotaverine
Breastfeeding (insufficient data)

Serious adverse effects

Allergic reactions – urticaria, angioedema (rare)
Severe hypotension (with intravenous administration)

Common adverse effects

Headache
Dizziness
Nausea
Hypotension

PregnancyFDA 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.

Breastfeeding

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.

Calculate RID Full profile on NIH LactMed ↗

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

Frequently asked

What is Drotaverine used for?

Drotaverine is evaluated for the following indications with varying evidence strength: Dysmenorrhea (evidence tier D), Abdominal smooth muscle spasm (evidence tier D), Biliary dyskinesia (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Drotaverine?

Common side effects of Drotaverine (≥ 1 in 100): Headache, Dizziness, Nausea, Hypotension. See the Safety section for uncommon and serious reactions.

Is Drotaverine safe during pregnancy?

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.

Is Drotaverine compatible with breastfeeding?

Who should not take Drotaverine?

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.

Practical notes

Timing and administration

Take 40–80 mg 2–3 times daily. Maximum daily dose 240 mg. May be taken regardless of food. Onset of action is 15–20 minutes orally. Intramuscular injection works within 5–10 minutes.

Special situations

Safety

Contraindications

Severe hepatic or renal insufficiency
Severe heart failure (low cardiac output syndrome)
Hypersensitivity to drotaverine
Breastfeeding (insufficient data)

Serious adverse effects

Allergic reactions – urticaria, angioedema (rare)
Severe hypotension (with intravenous administration)

Common adverse effects

Headache
Dizziness
Nausea
Hypotension

PregnancyFDA 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.

Breastfeeding

Calculate RID Full profile on NIH LactMed ↗

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

Frequently asked

What is Drotaverine used for?

What are the side effects of Drotaverine?

Common side effects of Drotaverine (≥ 1 in 100): Headache, Dizziness, Nausea, Hypotension. See the Safety section for uncommon and serious reactions.

Is Drotaverine safe during pregnancy?

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.

Is Drotaverine compatible with breastfeeding?

Who should not take Drotaverine?