Medicine 2: Drotaverine

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Medicine 2: Drotaverine

What is it?

Drotaverine is a medicine that helps relax muscles and reduce cramps. It works by blocking a certain enzyme (PDE4) in the body. Drotaverine is commonly used to treat pain and discomfort caused by conditions like stomach cramps, bile duct problems, and other issues involving tight or spasming muscles.¹

How does it work?

Drotaverine inhibits the PDE4 isoenzyme, leading to smooth muscle relaxation. However, in the airway and uterine smooth muscle, it might bind to L-type calcium channels, causing further smooth muscle relaxation. This relaxation can help reduce the spasms and contractions that cause menstrual pain.²

What is the efficacy?

Method: Studies were done to assess the efficacy of Drotaverine in treating dysmenorrhea. Both studies were randomized, double-blind clinical trials involving women aged 18–35 years with primary dysmenorrhea and moderate to severe pain. In one study, participants received either drotaverine (80 mg) or ibuprofen (400 mg), while in the other, they were given either a combination of aceclofenac (100 mg) with drotaverine (80 mg) or aceclofenac (100 mg) alone, for up to 3 days. Pain relief and intensity were measured at regular intervals for several hours after dosing, along with overall treatment effectiveness, medication use, and tolerability.^3,4

Results: In the first study, ibuprofen provided faster and greater pain relief than drotaverine alone, with more women rating it as highly effective, though both drugs were well tolerated. In the second study, combining aceclofenac with drotaverine led to quicker, stronger pain relief and reduced total medication use compared to aceclofenac alone, with higher satisfaction ratings from both patients and doctors.

Conclusion: Drotaverine alone is less effective than standard NSAIDs like ibuprofen for relieving period pain, but when combined with an NSAID such as aceclofenac, it offers faster, stronger relief and reduces the need for extra doses. Both approaches were safe and well tolerated by participants.

Side-effects:

Short-term effects: Nausea, constipation, diarrhea.

Long-term effects: Hypertension and palpitations.

References

1. National Center for Biotechnology Information. PubChem Compound Summary for CID 1712095, Drotaverine [Internet]. Bethesda (MD): National Library of Medicine (US); [cited 2025 May 20]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Drotaverine

1. Traserra S, Barber C, Alcalá-González LG, Landolfi S, Lange R, Malagelada C, et al. Evaluation of the mechanism of action of paracetamol, drotaverine, and peppermint oil and their effects in combination with hyoscine butylbromide on colonic motility: human ex-vivo study. Front Pharmacol. 2024 Jul 10;15:1384070. doi: 10.3389/fphar.2024.1384070.

1. Pareek A, Chandurkar NB, Patil RT, Agrawal SN, Uday RB, Tambe SG. Efficacy and safety of aceclofenac and drotaverine fixed-dose combination in the treatment of primary dysmenorrhoea: a double-blind, double-dummy, randomized comparative study with aceclofenac. Eur J Obstet Gynecol Reprod Biol. 2010 Sep;152(1):86–90.

2. Dębska M, Mazurek M, Niemiec T, Dębski R. Comparative efficacy and tolerability of drotaverine 80mg and ibuprofen 400mg in patients with primary dysmenorrhoea–Protocol DOROTA. Ginekologia Polska. 2007;78(12).