Papaverine Hydrochloride is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Class I recall (most serious) — August 26, 2026: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde Only the lots listed are affected. Check the lots
- Type
- Prescription only (Rx)
- Taken
- Intravenous
- Label
- American Regent, Inc., revised July 27, 2026 · full label on DailyMed
- Generic
- No · details
What it is used for
Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.
Who should not take it (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.
Precautions
General Papaverine Hydrochloride Injection, USP, should not be added to Lactated Ringer’s Injection, because precipitation would result. Papaverine Hydrochloride should be used with caution in patients with glaucoma. The medication should be discontinued if hepatic hypersensitivity with gastrointestinal symptoms, jaundice, or eosinophilia becomes evident or if liver function test values become altered. 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. 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. Usage in Children Safety and effectiveness in children have not been established.
Side effects (adverse reactions)
The following side effects have been reported: general discomfort, nausea, abdominal discomfort, anorexia, constipation or diarrhea, skin rash, malaise, vertigo, headache, intensive flushing of the face, perspiration, increase in the depth of respiration, increase in heart rate, a slight rise in blood pressure, and excessive sedation. Hepatitis, probably related to an immune mechanism, has been reported infrequently. Rarely, this has progressed to cirrhosis.
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.
Breastfeeding
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.
Use in children
Usage in Children Safety and effectiveness in children have not been established.
Is there a generic Papaverine Hydrochloride?
No. The FDA has not approved a generic version yet.
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Papaverine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class I Ongoing
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Lots, distribution and details
- Lots / codes
- Lot #: 25202, Exp. Date: 11/30/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 86,100 vials
- Recall started
- July 24, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0800-2026
-
Class II Ongoing
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13
- Distribution
- Nationwide and PR
- Quantity
- 6
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-765-2013
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Papaverine Hydrochloride
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 9e5e2ce4-7a57-4c61-a826-64c8d11d038e.