Papaverine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Papaverine Hydrochloride
Generic name
PAPAVERINE HYDROCHLORIDE
Manufacturer
Oryza Pharmaceuticals Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
5ba6e650-a5b5-4381-a62a-b7a6df73e8e6
SPL ID
2b4bd8c6-2b93-d435-e063-6394a90ae742
Version
4
Effective date
2025-01-09
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:04:31
Harmonized routes table
Harmonized routes
INTRAVENOUS

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.