PAPAVERINE: 341 Adverse Event Reports & Safety Profile
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Route: INTRAVENOUS · Manufacturer: American Regent, Inc. · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 19960919 · Latest Report: 20250509
What Are the Most Common PAPAVERINE Side Effects?
All PAPAVERINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 165 | 48.4% | 108 | 62 |
| Drug abuse | 123 | 36.1% | 84 | 29 |
| Depressed level of consciousness | 63 | 18.5% | 13 | 49 |
| Hypotension | 62 | 18.2% | 0 | 49 |
| Balance disorder | 52 | 15.3% | 2 | 49 |
| Fall | 52 | 15.3% | 1 | 50 |
| Cognitive disorder | 51 | 15.0% | 0 | 50 |
| Drug interaction | 51 | 15.0% | 12 | 33 |
| Pain | 51 | 15.0% | 0 | 49 |
| Sedation complication | 51 | 15.0% | 0 | 50 |
| Blood calcium decreased | 50 | 14.7% | 0 | 49 |
| Constipation | 50 | 14.7% | 0 | 49 |
| Creatinine renal clearance decreased | 50 | 14.7% | 0 | 49 |
| Mobility decreased | 50 | 14.7% | 0 | 49 |
| Orthostatic hypotension | 50 | 14.7% | 0 | 49 |
| Sedation | 50 | 14.7% | 0 | 49 |
| Dyspnoea | 42 | 12.3% | 12 | 29 |
| Overdose | 37 | 10.9% | 10 | 26 |
| Renal function test abnormal | 30 | 8.8% | 0 | 29 |
| Death | 29 | 8.5% | 29 | 3 |
Who Reports PAPAVERINE Side Effects? Age & Gender Data
Gender: 43.4% female, 56.6% male. Average age: 53.4 years. Most reports from: CA. View detailed demographics →
Is PAPAVERINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 4 | 0 | 0 |
| 2012 | 1 | 1 | 0 |
| 2013 | 4 | 3 | 0 |
| 2016 | 11 | 0 | 0 |
| 2017 | 21 | 20 | 1 |
| 2018 | 5 | 0 | 5 |
| 2019 | 11 | 9 | 2 |
| 2020 | 3 | 0 | 2 |
| 2021 | 8 | 5 | 0 |
| 2022 | 9 | 2 | 1 |
| 2023 | 6 | 2 | 1 |
| 2024 | 1 | 0 | 0 |
| 2025 | 1 | 0 | 1 |
What Is PAPAVERINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 222 |
| Angina pectoris | 25 |
| Coronary artery disease | 22 |
| Chest pain | 21 |
| Erectile dysfunction | 7 |
| Coronary artery bypass | 6 |
PAPAVERINE vs Alternatives: Which Is Safer?
Official FDA Label for PAPAVERINE
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. It does not contain a phenanthrene group as do morphine and codeine.
Papaverine
Hydrochloride, USP, is 6,7-dimethoxy-1- veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C 20 H 21 NO 4
- HCI. The molecular weight is 375.85. The structural formula is as shown.
Papaverine
Hydrochloride occurs as white crystals or white crystalline powder. One gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is soluble in chloroform and practically insoluble in ether.
Papaverine Hydrochloride
Injection, USP, is a clear, colorless to pale-yellow solution.
Papaverine
Hydrochloride, for parenteral administration, is a smooth-muscle relaxant that is available in vials containing 30 mg/mL. Each vial also contains edetate disodium 0.005%.
The
10 mL vials also contain chlorobutanol 0.5% as a preservative. pH may be adjusted with sodium citrate and/or citric acid.
Adobe
Systems
FDA Approved Uses (Indications)
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Papaverine Hydrochloride may be administered intravenously or intramuscularly. The intravenous route is recommended when an immediate effect is desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid uncomfortable or alarming side effects. Parenteral administration of papaverine hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment of cardiac extrasystoles, 2 doses may be given 10 minutes apart.
Contraindications
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.
Known Adverse Reactions
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. To report SUSPECTED ADVERSE REACTIONS, contact Oryza Pharmaceuticals, Inc. at 1-888-296-9383 (or FDA 1-800-FDA-1088) or www.fda.gov/medwatch.
Precautions
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.