Palovarotene Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 13, 2024.

Applies to palovarotene: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Embryo-Fetal Toxicity. Palovarotene is contraindicated in pregnancy.

Palovarotene may cause fetal harm.

Because of the risk of teratogenicity and to minimize fetal exposure, palovarotene is to be administered only if conditions for pregnancy prevention are met.Premature Epiphyseal Closure. Premature epiphyseal closure occurs in growing pediatric patients treated with Palovarotene, close monitoring is recommended

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 side effects

• 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 adverse events

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

• 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]

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]

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

• Common (1% to 10%): Depressed mood, irritability
• Frequency not reported: Suicidal ideation^[Ref]

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

Renal

• Frequency not reported: Proteinuria^[Ref]

Respiratory

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

Further information

Palovarotene 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.

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

Medical Disclaimer