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.

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

• 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

• 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
• bloating
• bloody cough
• bloody or cloudy urine
• bone tenderness or aching
• burning or stinging of the skin
• chest pain
• 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 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, 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
• redness or soreness around the fingernails
• redness, soreness, or itching skin
• seizures
• sensitivity of the eyes to sunlight
• sneezing
• 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
• tightness in the chest
• unusual bleeding or bruising
• 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

• 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

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

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]

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

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%): 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]

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

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%): 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]

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]