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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 0215da26-b413-4a5a-b6aa-bc8f7c81f4a3 | id | |
| spl set id | a155354d-ebd8-429e-9538-25957de914b1 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.