DepoDur Side Effects

Generic Name: morphine liposomal

Note: This page contains information about the side effects of morphine liposomal. Some of the dosage forms included on this document may not apply to the brand name DepoDur.

Not all side effects for DepoDur may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Applies to morphine liposomal: injectable suspension extended release

Respiratory

Respiratory side effects including decreased oxygen saturation (>10%), hypoxia (5% to 10%), respiratory depression (2% to 5%), hypercapnia (2% to 5%), and dyspnea (2% to 5%) have been reported. During postmarketing experience, severe respiratory depression, involving apnea or respiratory arrest, and cardiac arrest have been reported following administration of labeled doses of morphine sulfate extended-release liposome injection.[Ref]

Four percent of the patients who received morphine liposomal in clinical trials required treatment with narcotic antagonists for respiratory depression. Ninety percent of events of respiratory depression were reported to have started within the first 24 hours after dosing with morphine liposomal. Respiratory depression occurred in 0.6% of patients after more than 48 hours.[Ref]

Cardiovascular

Cardiovascular side effects including hypotension (>10%), tachycardia (5% to 10%), hypertension (2% to 5%) and bradycardia (2% to 5%) have been reported.[Ref]

Genitourinary

Genitourinary side effects including urinary retention (>10%), bladder spasm (2% to 5%), and oliguria (2% to 5%) have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including vomiting (>10%), constipation (>10%), nausea (>10%), flatulence (5% to 10%), paralytic ileus (2% to 5%), dyspepsia (2% to 5%), and abdominal distention (2% to 5%) have been reported.[Ref]

Dermatologic

Dermatologic side effects including pruritus (>10%), hypoesthesia (2% to 5%), and increased sweating (2% to 5%) have been reported.[Ref]

General

General side effects including pyrexia (>10%), headache (>10%), dizziness (>10%), insomnia (5% to 10%), somnolence (2% to 5%), anxiety (2% to 5%), and back pain (2% to 5%) have been reported.[Ref]

Hematologic

Hematologic side effects including anemia (>10%), hypokalemia (2% to 5%), and decreased hematocrit (2% to 5%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including rigors (2% to 5%) have been reported.[Ref]

Nervous system

Nervous system side effects including paresthesia (2% to 5%) have been reported. During postmarketing experience, central nervous system depression, including obtunded feeling, non-arousable condition, unresponsiveness, confusion, and lethargy, has been reported following epidural administration of morphine sulfate extended-release liposome injection.[Ref]

In most of these cases with central nervous system depression following epidural administration of morphine sulfate extended-release liposome injection, there was concomitant administration of different narcotics or hypnotic/sedative medications in the postoperative period.[Ref]

Oncologic

Oncologic side effects have included an increase in DNA fragmentation when incubated in vitro with a human lymphoma cell line. In vivo, morphine has been reported to produce an increase in the frequency of micronuclei in bone marrow cells and immature red blood cells in the mouse micronucleus test and to induce chromosomal aberrations in murine lymphocytes and spermatids.[Ref]

Some of the in vivo clastogenic effects reported with morphine in mice may be directly related to increases in glucocorticoid levels produced by morphine in that species.[Ref]

References

1. "Product Information. DepoDur (morphine liposomal)." Endo Laboratories LLC, Chadds Ford, PA.

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