FDA label 93ccde7f-e8d7-43d9-99ba-01a99d52f7dd
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
- d4f445c2-5745-4827-817d-5d4c50884c58
- SPL ID
- 93ccde7f-e8d7-43d9-99ba-01a99d52f7dd
- Version
- 2
- Effective date
- 2012-06-28
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:16:42
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 | 93ccde7f-e8d7-43d9-99ba-01a99d52f7dd | id | |
| spl set id | d4f445c2-5745-4827-817d-5d4c50884c58 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Morphine Sulfate Injection may be habit forming (see DRUG ABUSE AND DEPENDENCE ). Overdoses may cause respiratory depression, coma and death (see OVERDOSAGE ). Do not use injection if it contains a precipitate. Head Injury and Increased Intracranial Pressure The respiratory-depressant effects of morphine and its 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 produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, morphine must be used with extreme caution and only if its use is deemed essential. Asthma and Other Respiratory Conditions Morphine should be used with extreme caution in patients having an acute asthmatic attack, in patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Hypotensive Effect The administration of morphine may result in severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as the phenothiazines or certain anesthetics. Morphine may produce orthostatic hypotension in ambulatory patients. Intravenous Use If necessary, morphine may be given intravenously, but the injection should be given very slowly. Rapid intravenous injection of narcotic analgesics, including morphine, increases the incidence of adverse reactions. Severe respiratory depression, apnea, hypotension, peripheral circulatory collapse, cardiac arrest, as well as anaphylactoid reactions, have occurred. Morphine should not be administered intravenously unless a narcotic antagonist and the facilities for resuscitation and assisted or controlled respiration are immediately available. When morphine is given parenterally, especially intravenously, the patient should be lying down.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The major hazards of morphine, as with other narcotic analgesics, are respiratory depression, and, to a lesser degree, circulatory depression; respiratory arrest, shock and cardiac arrest have occurred, particularly with overdosage or rapid intravenous administration. Anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions include sedation, lightheadedness, dizziness, nausea, vomiting and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down. Central Nervous System Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, transient hallucinations and disorientation, visual disturbances. Gastrointestinal Constipation, biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Cardiovascular Tachycardia, bradycardia, palpitation, faintness, syncope and orthostatic hypotension. Genitourinary Narcotic analgesics may cause oliguria and urinary retention. Allergic Allergic reactions to opiates occur infrequently; pruritus, urticaria and other skin rashes are common. Anaphylactoid reactions have been reported following intravenous administration. Other Opiate-induced histamine release may be responsible for the flushing of the face, sweating and pruritus often seen with these drugs. Wheals and urticaria at the site of injection are probably related to histamine release. Local tissue irritation, pain and induration have been reported following repeated subcutaneous injection.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.