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Fospropofol Side Effects

For the Consumer

Applies to fospropofol: intravenous solution

Along with its needed effects, fospropofol 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 fospropofol:

More common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Less common
  • Bluish lips or skin
  • blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • sweating
  • unusual tiredness or weakness
Rare
  • Difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • shortness of breath

Some side effects of fospropofol 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
  • Itching skin
Less common
  • Headache
  • nausea
  • vomiting

For Healthcare Professionals

Applies to fospropofol: intravenous solution

Respiratory

Very common (10% or more): Hypoxemia (up to 11%)
Common (1% to 10%): Procedural pain (bronchoscopy)
Uncommon (0.1% to 1%): Apnea[Ref]

Nervous system

-Paresthesia includes the following terms: paresthesia genital male; burning sensation; genital burning sensation; vaginal burning sensation; skin burning sensation; genital pain (reported as burning); perineal pain (reported as burning); anal discomfort (reported as burning); chest pain (reported as burning); ear discomfort (reported as burning); nasal discomfort (reported as burning); buttock pain (reported as stinging); groin pain (reported as stinging); pain (reported as stinging); sensory disturbance (reported as nonspecific sensation in pubic area).
-Pruritus includes the following terms: genital pruritus female; genital pruritus male; pruritus genital; pruritus ani; pruritus generalized.
-Paresthesias (including burning, tingling, stinging) and/or pruritus, usually manifested in the perineal region, were the most frequently recorded adverse reactions in clinical trials. Paresthesias and pruritus generally occurred within 5 minutes after administration of the initial dose and were generally transient and mild to moderate in intensity. The pharmacologic basis of these sensory phenomena is unknown. No pretreatments, including the use of nonsteroidal anti-inflammatory drugs, opioids, or lidocaine, are known to have an effect on or to reduce the incidence of these sensations.[Ref]

Very common (10% or more): Paresthesia (up to 74%)
Common (1% to 10%): Headache[Ref]

Cardiovascular

Common (1% to 10%): Hypotension[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting[Ref]

Other

Common (1% to 10%): Procedural pain[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 28%)[Ref]

References

1. "Product Information. Lusedra (fospropofol)." Eisai Inc, Teaneck, NJ.

Some side effects of fospropofol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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