Palovarotene Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.

Applies to palovarotene: oral capsule.

Serious side effects of Palovarotene

Along with its needed effects, palovarotene 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 immediately if any of the following side effects occur while taking palovarotene:

More common

• Back pain
• bone pain
• dark urine
• difficulty in moving
• difficulty in swallowing
• dry lips or skin
• fast heartbeat
• flushing, redness of the skin
• headache
• itching of the skin
• joint pain
• lack or loss of strength
• lack or slowing of normal growth in children
• loss of appetite
• loss or thinning of the hair
• muscle aches, cramps, pain, or stiffness
• nausea or vomiting
• stomach pain, severe
• swelling of the face, throat, or tongue
• swelling of the hands, ankles, feet, or lower legs
• swollen joints
• trouble breathing
• unusual tiredness or weakness
• unusually warm skin
• yellow eyes or skin

Incidence not known

• Bloating
• chills
• constipation
• discouragement
• fear, nervousness
• feeling sad or empty
• fever
• indigestion
• irritability
• lack of appetite
• loss of bone mineral density
• loss of interest or pleasure
• pain or swelling in the arms or legs without any injury
• pains in the stomach, side, or abdomen, possibly radiating to the back
• thoughts or attempts at killing oneself
• trouble concentrating
• trouble sleeping

For Healthcare Professionals

Applies to palovarotene: oral capsule.

General

Most common adverse reactions reported with an incidence of 10% or more were dry skin, dry lip, arthralgia, pruritus, pain in extremity, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue.^[Ref]

Dermatologic

The most common adverse events that led to treatment discontinuation were mucocutaneous reactions during 20/10 mg flare-up treatment (37%) and during chronic treatment (4%). Cellulitis has been reported in 2 patients (1.4%).^[Ref]

Very common (10% or more): Dry skin (up to 61%), pruritus (up to 48%; includes pruritus, generalized pruritus, pruritic rash), erythema (up to 32%; includes erythema, generalized erythema, flushing, erythematous rash), alopecia (up to 30%), rash (up to 30%; includes rash, generalized rash, maculopapular rash), skin exfoliation (up to 29%), skin reaction (up to 24%), skin abrasion (up to 21%), drug eruption (up to 17%), paronychia (up to 14%), skin irritation (up to 11%)

Common (1% to 10%): Blister, decubitus ulcer, ingrown nail, madarosis, onychoclasis, skin fissures, sunburn

Frequency not reported: Cellulitis, skin fragility, skin infection, swelling face, urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Lip dry (up to 47%; includes lip dry, chapped lips, cheilitis), chapped lips (up to 17%), nausea (up to 15%), dry mouth (up to 13%), cheilitis (up to 11%)

Common (1% to 10%): Diarrhea, vomiting

Frequency not reported: Abdominal pain, gastroesophageal reflux disease^[Ref]

Hematologic

Frequency not reported: Anemia^[Ref]

Hepatic

Common (1% to 10%): Elevated ALT^[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity (up to 20%; includes drug eruption, hypersensitivity, allergic pruritus, drug hypersensitivity)^[Ref]

Metabolic

Very common (10% or more): Peripheral edema (up to 19%; includes peripheral swelling, edema peripheral)

Common (1% to 10%): Decreased appetite, hypertriglyceridemia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 36%), pain in extremity (up to 29%), epiphysis premature closure (up to 27%), back pain (up to 17%; includes back pain, flank pain, sciatica), musculoskeletal pain (up to 14%), myalgia (up to 12%; includes myalgia, musculoskeletal discomfort)

Common (1% to 10%): Epiphysis premature fusion, joint swelling

Frequency not reported: Ankle fracture, metabolic bone disorder^[Ref]

Premature physeal closure was reported in 27% patients under 18 years of age. It was observed to be more common in younger compared to older patients (31% of patients 8 or 10 years of age to less than 14 years; no patients 14 years or older).^[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%; includes headache, migraine)

Frequency not reported: Seizure^[Ref]

Ocular

Very common (10% or more): Dry eye (up to 25%)

Common (1% to 10%): Ocular hyperemia

Frequency not reported: Conjunctivitis, night blindness^[Ref]

Oncologic

Frequency not reported: Pyogenic granuloma^[Ref]

Other

Very common (10% or more): Fatigue (up to 11%; includes fatigue, lethargy, asthenia, malaise)

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

Psychiatric

In clinical study, there was no treatment-related increase in suicidal ideation, suicidal behavior, or psychiatric disorders overall compared to untreated subjects.^[Ref]

Common (1% to 10%): Depressed mood, irritability

Frequency not reported: Suicidal ideation^[Ref]

Renal

Frequency not reported: Proteinuria^[Ref]

Respiratory

Very common (10% or more): Epistaxis (up to 12%)^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer