Applies to oliceridine: intravenous solution.
Warning
Intravenous route (Solution)
Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressantsOliceridine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor all patients regularly for the development of behaviors or conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.Prolonged use of oliceridine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of oliceridine with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
Serious side effects of Oliceridine
Along with its needed effects, oliceridine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking oliceridine:
More common
- Confusion
- decreased urine
- dizziness
- dry mouth
- fast or irregular heartbeat
- increased thirst
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- seizures
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- bone pain
- chest tightness
- difficult or labored breathing
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- extremely shallow or slow breathing
- fainting
- fever
- muscle spasms (tetany) or twitching seizures
- numbness and tingling around the mouth, fingertips, or feet
- pale skin
- stomach cramps
- sweating
- trembling
- tremor
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur while taking oliceridine:
Symptoms of overdose
- Bigger, dilated, or enlarged pupils (black part of the eye)
- chest pain or discomfort
- cold and clammy skin
- confusion
- constricted pupils
- coughing that sometimes produces a pink frothy sputum
- increased sensitivity of the eyes to light
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- no muscle tone or movement
- pale or blue lips, fingernails, or skin
- slow heartbeat
- swelling in the legs and ankles
Other side effects of Oliceridine
Some side effects of oliceridine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- constipation
- feeling of warmth
- headache
- itching, skin rash
- redness of the face, neck, arms, and occasionally, upper chest
Less common
- Anxiety
- belching
- diarrhea
- heartburn
- indigestion
- muscle spasm
- pale skin, pain, or redness at the injection site
- passing gas
- restlessness
- stomach discomfort, upset, or pain
- trouble sleeping
For Healthcare Professionals
Applies to oliceridine: intravenous solution.
General
The most common adverse events were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.[Ref]
Nervous system
Very common (10% or more): Dizziness (35%), somnolence (19%), sedation (14%)
Common (1% to 10%): Headache[Ref]
Respiratory
Common (1% to 10%): Hypoxia, oxygen saturation decreased, cough dyspnea[Ref]
Gastrointestinal
Very common (10% or more): Nausea (63%), vomiting (41%), constipation (14%)
Common (1% to 10%): Flatulence, dry mouth, dyspepsia, diarrhea[Ref]
Dermatologic
Very common (10% or more): Pruritus (15%)
Common (1% to 10%): Hyperhidrosis, rash, pruritus generalized[Ref]
Cardiovascular
Common (1% to 10%): Hot flush, tachycardia blood pressure increased, hypotension, flushing[Ref]
Local
Common (1% to 10%): Infusion site extravasation[Ref]
Hematologic
Common (1% to 10%): Anemia[Ref]
Metabolic
Common (1% to 10%): Hypokalemia, hypocalcemia, hypophosphatemia, hypomagnesemia[Ref]
Musculoskeletal
Very common (10% or more): Back pain (13%)
Common (1% to 10%): Muscle spasms[Ref]
Psychiatric
Common (1% to 10%): Anxiety, insomnia, restlessness[Ref]
Other
Common (1% to 10%): Pyrexia[Ref]
Hepatic
Common (1% to 10%): Alanine aminotransferase increased[Ref]
