Papaverine

FDA label, American Regent, Inc., intravenous, effective 2026-07-27. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

Intravenous injection of papaverine is contraindicated in the presence of complete atrioventricular heart block. When conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. Papaverine Hydrochloride is not indicated for the treatment of impotence by intracorporeal injection. The intracorporeal injection of papaverine hydrochloride has been reported to have resulted in persistent priapism requiring medical and surgical intervention.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for papaverine. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Usage In Pregnancy - Pregnancy Category C No teratogenic effects were observed in rats when papaverine hydrochloride was administered subcutaneously as a single agent. It is not known whether papaverine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Papaverine Hydrochloride should be given to a pregnant woman only if clearly needed.

Lactation

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when papaverine hydrochloride is administered to a nursing woman.

Breastfeeding (LactMed)

No information is available on the use of papaverine during breastfeeding. If a mother requires papaverine, it is not a reason to discontinue breastfeeding. Until more data become available, papaverine should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. If papaverine is used, monitor the infant for sedation and poor feeding, especially in younger, exclusively breastfed infants.

Source: LactMed: Papaverine (NICHD, public domain)Revised Sep 15, 2025

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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Products and NDCs

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Recruiting clinical trials

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