FDA label 0215da26-b413-4a5a-b6aa-bc8f7c81f4a3

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)

SPL set ID
a155354d-ebd8-429e-9538-25957de914b1
SPL ID
0215da26-b413-4a5a-b6aa-bc8f7c81f4a3
Version
4
Effective date
2014-01-07
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:50:48

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Respiratory Depression: Morphine produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Morphine also affects centers that control respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. (See OVERDOSAGE .) Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics can produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Central Nervous System: Sedation, drowsiness, mental clouding, dizziness, lethargy, impairment of mental and physical performance, anxiety, convulsion, fear, miosis, dysphoria, psychic dependence, mood changes, and respiratory depression. Gastrointestinal System: Nausea, vomiting, increased pressure in the biliary tract, constipation. Cardiovascular System: Orthostatic hypotension, fainting, tachycardia, circulatory depression, peripheral circulatory collapse, and cardiac arrest have occurred after rapid intravenous injection. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Other: Flushing, sweating, pruritus, allergic reactions, suppressed cough reflex.

Reported adverse events (FAERS/openFDA)#

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