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Sotret Side Effects

Generic name: isotretinoin

Medically reviewed by Last updated on Feb 13, 2024.

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

Applies to isotretinoin: oral capsule, oral capsule liquid filled.


Oral route (Capsule, Liquid Filled; Capsule)

Warning: Embryo-Fetal Toxicity - Contraindicated in PregnancyIsotretinoin can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin immediately and refer the patient to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling.Because of the risk of embryo-fetal toxicity, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS.

Serious side effects of Sotret

Along with its needed effects, isotretinoin (the active ingredient contained in Sotret) 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 isotretinoin:

More common


Incidence not known

Other side effects of Sotret

Some side effects of isotretinoin 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

Incidence not known

For Healthcare Professionals

Applies to isotretinoin: compounding powder, oral capsule.


The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).[Ref]


Very common (10% or more): Cheilitis/dry lips (up to 90%)

Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease

Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums[Ref]


Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)

Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis

Rare (0.01% to 0.1%): Agranulocytosis

Very rare (less than 0.01%): Lymphadenopathy

Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts[Ref]


Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)

Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein

Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia

Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein

Postmarketing reports: Increased fasting blood glucose levels[Ref]


Bronchospasm occurred in patients receiving treatment, especially in those with asthma.[Ref]

Very common (10% or more): Epistaxis (Up to 30%)

Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis

Very rare (less than 0.01%): Bronchospasm, dry throat

Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration[Ref]


In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks[Ref]

Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma

Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia

Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue

Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles

Postmarketing reports: Bruising, seborrhea[Ref]


Papilledema occurred as a sign of benign intracranial hypertension.[Ref]

Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation

Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum

Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation[Ref]


Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels

Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons

Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain[Ref]

Back pain occurred more frequently in children and adolescent patients.

Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.[Ref]


Common (1% to 10%): Proteinuria, microscopic or gross hematuria

Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine[Ref]

Nervous system

Common (1% to 10%): Headache

Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness

Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope[Ref]


Common (1% to 10%): Transient and reversible increased transaminase levels

Very rare (less than 0.01%): Hepatitis

Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin[Ref]


Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations

Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide

Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders

Postmarketing reports: Auditory hallucinations[Ref]

Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.[Ref]


Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity

Frequency not reported: Allergic reactions[Ref]


Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise

Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)

Postmarketing reports: Infection[Ref]


Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis

Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing[Ref]


Very rare (less than 0.01%): Glomerulonephritis[Ref]

Frequently asked questions


1. (2001) "Product Information. Accutane (isotretinoin)." Roche Laboratories

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

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.