Sotret Side Effects

Generic name: isotretinoin

Medically reviewed by Drugs.com. Last updated on Aug 25, 2024.

Note: This document provides detailed information about Sotret Side Effects associated with isotretinoin. Some dosage forms listed on this page may not apply specifically to the brand name Sotret.

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

Important warnings This medicine can cause some serious health issues

Oral route (capsule, liquid filled; capsule)

Warning: Embryo-Fetal Toxicity - Contraindicated in Pregnancy. Isotretinoin 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 side effects

• bone or joint pain
• burning, redness, itching, or other signs of eye inflammation
• difficulty with moving
• nosebleeds
• scaling, redness, burning, pain, or other signs of inflammation of the lips
• skin infection or rash

Rare side effects

• attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
• back pain
• bleeding or inflammation of the gums
• blurred vision or other changes in vision
• changes in behavior
• decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
• diarrhea (severe)
• headache (severe or continuing)
• mental depression
• nausea
• pain or tenderness of the eyes
• pain, tenderness, or stiffness in the muscles (long-term treatment)
• rectal bleeding
• stomach pain (severe)
• vomiting
• yellow eyes or skin

Incidence not known

• black, tarry stools
• blistering, peeling, or loosening of the skin
• bloating
• bloody cough
• bloody or cloudy urine
• bone tenderness or aching
• burning or stinging of the skin
• chest pain or tightness
• confusion
• constipation
• continuing ringing or buzzing, or other unexplained noise in the ears
• cough
• dark-colored urine
• decrease in height
• difficulty breathing
• difficulty speaking
• difficulty swallowing
• discharge from the eyes
• dizziness
• double vision
• ear pain
• excessive tearing
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fever with or without chills
• fractures or delayed healing
• heartburn
• high blood pressure
• hives, itching, or skin rash
• hoarseness
• inability to move the arms, legs, or facial muscles
• inability to speak
• indigestion
• inflamed tissue from infection
• irregular yellow patch or lump on the skin
• irritation
• joint redness, stiffness, or swelling
• lack or slowing of normal growth in children
• loosening of the fingernails
• loss of appetite
• loss of bladder control
• loss or change in hearing
• muscle cramps, pain, spasms, or weakness
• pain in the ribs, arms, or legs
• pain or burning in the throat
• pain or tenderness around the eyes and cheekbones
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• painful or difficult urination
• pains in the chest, groin, or legs, especially calves of the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness or soreness around the fingernails
• redness, soreness, or itching skin
• seizures
• sensitivity of the eyes to sunlight
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stuffy or runny nose
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of severe acne on the chest and trunk
• sudden onset of slurred speech
• swelling of the eyelids, face, lips, hands, lower legs, or feet
• swollen, painful or tender lymph glands in the neck, armpit, or groin
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• use of extreme physical or emotional force
• watery or bloody diarrhea

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 side effects

• crusting of the skin
• difficulty in wearing contact lenses (may continue after medicine is stopped)
• dryness of the eyes (may continue after treatment is stopped)
• dryness of the mouth or nose
• dryness or itching of the skin
• headache (mild)
• increased sensitivity of the skin to sunlight
• peeling of the skin on palms of the hands or soles of the feet
• stomach upset
• thinning of the hair (may continue after treatment is stopped)

Incidence not known

• abnormal menstruation
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
• changes in fingernails or toenails
• dandruff
• darkening of the skin
• hair abnormalities
• hair loss
• increased hair growth, especially on the face
• lightening of normal skin color
• lightening of treated areas of dark skin
• nervousness
• oily skin
• redness of the face
• severe sunburn
• skin rash, encrusted, scaly and oozing
• stomach burning
• sweating
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually warm skin of the face
• voice changes

For healthcare professionals

Applies to isotretinoin: compounding powder, oral capsule.

General adverse events

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

Gastrointestinal

• 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]

Hematologic

• 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]

Metabolic

• 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]

Respiratory

• 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]

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

Dermatologic

• 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]

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

Ocular

• 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]

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

Musculoskeletal

• 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]

Genitourinary

• 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]

Hepatic

• 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]

Psychiatric

• 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]

Hypersensitivity

• Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
• Frequency not reported: Allergic reactions^[Ref]

Other

• 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]

Cardiovascular

• Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
• Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing^[Ref]

Renal

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

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Further information

Sotret 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