Difelikefalin Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 23, 2024.

Applies to difelikefalin: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to receive it.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. It may also cause confusion, mental changes, or problems with walking, which may lead to falls. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are receiving this medicine.

Serious side effects of difelikefalin

Along with its needed effects, difelikefalin 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 difelikefalin:

More common side effects

• dizziness
• falls
• trouble in walking

Less common side effects

• confusion
• irregular heartbeat
• mental depression or anxiety
• nausea or vomiting
• nervousness
• nightmares or unusually vivid dreams
• numbness or tingling in the hands, feet, or lips
• sleepiness or unusual drowsiness
• stomach pain
• trouble breathing
• weakness or heaviness of the legs

Other side effects of difelikefalin

Some side effects of difelikefalin 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 side effects

• diarrhea

Less common side effects

• headache

For healthcare professionals

Applies to difelikefalin: intravenous solution.

General adverse events

The most commonly reported adverse effects have included diarrhea, dizziness, nausea, back pain, gait disturbances, paresthesia, hyperkalemia, headache, vomiting, somnolence, and mental status change.^[Ref]

Dermatologic

• Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)^[Ref]

DRESS has been reported in only one individual case report, and its causal relationship is yet to be established.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea
• Uncommon (0.1% to 1%): Vomiting^[Ref]

Metabolic

• Common (1% to 10%): Hyperkalemia^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, headache, somnolence, gait disturbances, paresthesia^[Ref]

Gait disturbances includes preferred terms of falls and gait disturbances.

Paresthesia includes hypoesthesia, paresthesia oral and hypoesthesia oral.^[Ref]

Psychiatric

• Common (1% to 10%): Mental status change^[Ref]

Mental status change includes preferred terms of confusional state and mental status change.^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle pain, back pain^[Ref]

Other

• Frequency not reported: Fatigue^[Ref]

See also:

Further information

Difelikefalin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer