Sohonos Side Effects

Generic name: palovarotene

Medically reviewed by Drugs.com. Last updated on Jun 7, 2023.

Note: This document contains side effect information about palovarotene. Some dosage forms listed on this page may not apply to the brand name Sohonos.

Applies to palovarotene: oral capsule.

Warning

Oral route (Capsule)

Embryo-Fetal ToxicityPalovarotene 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 ClosurePremature epiphyseal closure occurs in growing pediatric patients treated with Palovarotene, close monitoring is recommended

Serious side effects of Sohonos

Along with its needed effects, palovarotene (the active ingredient contained in Sohonos) 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

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

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]

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]

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]