Lusedra Side Effects

Generic Name: fospropofol

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

For the Consumer

Applies to fospropofol: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by fospropofol (the active ingredient contained in Lusedra). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking fospropofol, check with your doctor or nurse immediately:

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

• 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

• Difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• shortness of breath

Minor Side Effects

Some of the side effects that can occur with fospropofol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Itching skin

• 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]

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

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