Palovarotene Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 4, 2024.

Applies to palovarotene: oral capsule.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests 1 week before treatment, during treatment, and for 1 month after the last dose. Use an effective form of birth control 1 month before treatment, during treatment, and for 1 month after the last dose. Tell your doctor right away if you think you have become pregnant.

You or your child should not donate blood to a blood bank during treatment and for 1 week after the last dose. This is to prevent a pregnant patient from receiving blood that contains the medicine.

This medicine may cause bone growth changes. Talk to your doctor if your child has lack or slowing of normal growth in children.

This medicine may decrease bone mineral density (bone thinning), which may increase the risk of fractures. Check with your doctor right away if you have back pain, bone or joint pain, difficulty in moving or walking, muscle pan or stiffness, or pain or swelling in the arms or legs without any injury.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

Check with your doctor right away if you have dry eye, dry lips, dry skin, flushing, redness of the skin, itching skin, loss or thinning of the hair, peeling of the skin, or unusually warm skin. These maybe symptoms of serious skin reactions.

Avoid overexposing your skin to sunlight. Your skin will be more prone to sunburn, dryness, or irritation. Do not use a sunlamp or tanning beds. Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

This medicine may decrease your ability to see in the dark. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

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:

For healthcare professionals

Applies to palovarotene: oral capsule.

General adverse events

The most common adverse reactions 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, fatigue, skin abrasion, drug eruption, chapped lips, paronychia, dry mouth, skin irritation, epistaxis, and cheilitis. The most common serious adverse reaction in pediatric patients (aged 8 to 10 years or older) was premature epiphyseal closure.^[Ref]

Cardiovascular

• Common (1% to 10%): Flushing

Dermatologic

• Very common (10% or more): Mucocutaneous adverse reactions (up to 98%), dry skin (up to 78.4%), pruritus (up to 55%), alopecia (up to 44%), rash (up to 42%), erythema (up to 37%), skin exfoliation/skin peeling (up to 31%), generalized pruritus (up to 30.9%), skin abrasion (up to 23%), drug eruption (up to 17%), paronychia (up to 15.8%), eczema (up to 15.1%), skin irritation (up to 12%)
• Common (1% to 10%): Cellulitis, sunburn, skin infection, onychoclasis, skin fissures, blister, decubitus ulcer, dermatitis, skin reaction, ingrowing nail, madarosis, urticaria, skin fragility

Retinoids:

• Frequency not reported: Photosensitivity reactions

Mucocutaneous adverse reactions included dry skin (78%), dry lip (up to 66%), pruritus (55%), alopecia (up to 44%), rash (up to 42%), erythema (up to 37%), skin exfoliation/skin peeling (31%), drug eruption (17%), dry eye (up to 26%), and skin irritation (up to 12%).

Pruritus included pruritus, generalized pruritus, and pruritic rash.

Erythema included erythema, generalized erythema, flushing, and erythematous rash.

Rash included rash, generalized rash, and maculopapular rash.

Gastrointestinal

• Very common (10% or more): Dry lip (up to 66%), nausea (up to 23.7%), vomiting (up to 23%), chapped lips (up to 17.3%), abdominal pain (up to 15.8%), diarrhea (up to 14.4%), dry mouth (up to 13%), cheilitis (up to 11%)
• Common (1% to 10%): Gastroesophageal reflux disease, increased lipase
• Frequency not reported: Acute pancreatitis

Dry lip included dry lip, chapped lips, and cheilitis.

Acute pancreatitis was reported in a drug-drug interaction study, possibly related to use of this drug with ketoconazole.

Genitourinary

• Common (1% to 10%): Proteinuria

Hematologic

• Common (1% to 10%): Anemia

Hepatic

• Common (1% to 10%): Elevated ALT

Retinoids:

• Frequency not reported: Elevated liver enzymes, severe hepatitis

Hypersensitivity

• Very common (10% or more): Hypersensitivity (up to 20%)

Hypersensitivity included drug eruption, hypersensitivity, allergic pruritus, and drug hypersensitivity.

Metabolic

• Very common (10% or more): Decreased appetite (up to 11.5%)
• Common (1% to 10%): Hypertriglyceridemia

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 43.9%), premature epiphyseal closure/fusion (up to 31%), pain in extremity (up to 37.4%), back pain (up to 18%), musculoskeletal pain (up to 17.3%), joint swelling (up to 16.5%), neck pain (up to 12.2%), myalgia (up to 12%), musculoskeletal chest pain (up to 10.1%), radiological spinal fracture
• Common (1% to 10%): Ankle fracture
• Uncommon (0.1% to 1%): Epiphyseal disorder
• Frequency not reported: Slowing of growth in height, decreased vertebral bone mineral content, decreased vertebral bone density

Retinoids:

• Frequency not reported: Bone toxicity, reduced bone mass, osteoporosis, fracture, hyperostotic changes/bone spurs, calcification of tendons/ligaments

Premature epiphyseal closure was observed by schedule imaging in 27% of patients younger than 18 years at enrollment; it was more common in younger compared to older patients (31% of patients 8 or 10 years to less than 14 years; no patients 14 years or older). Many affected patients showed slowing of growth in height.

Back pain included back pain, flank pain, and sciatica.

Myalgia included myalgia and musculoskeletal discomfort.

Nervous system

• Very common (10% or more): Headache (up to 25.9%), dizziness (up to 10.1%)
• Common (1% to 10%): Seizure

Systemic retinoids:

• Frequency not reported: Benign intracranial hypertension/pseudotumor cerebri

Headache included headache and migraine.

Systemic retinoids have been associated with benign intracranial hypertension (pseudotumor cerebri); some cases involved concomitant use of tetracyclines.

Ocular

• Very common (10% or more): Dry eye (up to 26%)
• Common (1% to 10%): Conjunctivitis, ocular hyperemia
• Frequency not reported: Night blindness

Oncologic

• Common (1% to 10%): Pyogenic granuloma

Other

• Very common (10% or more): Aggravated condition (up to 22.3%), peripheral edema (up to 19%), pyrexia (up to 15.1%), contusion (13.7%), peripheral swelling (up to 13.7%), fall (up to 12.2%), fatigue (up to 11%), ear infection (up to 10.1%)
• Common (1% to 10%): Swelling face

Peripheral edema included peripheral swelling and peripheral edema.

Fatigue included fatigue, lethargy, asthenia, and malaise.

Psychiatric

• Common (1% to 10%): Depressed mood, irritability, suicidal ideation
• Frequency not reported: New/worsening psychiatric events

Systemic retinoids:

• Frequency not reported: Depression, aggravated depression, anxiety, mood alterations, suicidal thoughts, suicidal behaviors

New/worsening psychiatric events included depression, anxiety, mood alterations, and suicidal thoughts/behaviors.

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

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 23.7%), nasopharyngitis (up to 22.3%), cough (up to 16.5%), epistaxis (up to 14.4%), oropharyngeal pain (up to 11.5%)

See also:

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.

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.

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