Accutane

Name: Accutane

Brand names

  • Absorica®
  • Accutane®
  • Amnesteem®
  • Claravis®
  • Myorisan®
  • Sotret®

What brand names are available for isotretinoin?

Claravis, Amnesteem, Absorica, Myorisan, Zenatane, Sotret

What are the side effects of isotretinoin?

The most common side effects of isotretinoin are:

  • Dry skin,
  • Itching,
  • Dry nose,
  • Nosebleeds (epistaxis),
  • Cracks in the corners of the mouth (chilitis),
  • Dry mouth,
  • Inflammation of the whites of the eyes.

Joint aches also are common. Patients may develop an increase in blood cholesterol and triglycerides. Psychiatric problems such as depression, hallucinations and suicidal behavior have been reported.

Other side effects include:

  • Joint aches
  • Increased cholesterol
  • Increased triglycerides
  • Increased glucose
  • Headache
  • Ringing in the ears
  • Insomnia
  • Abnormal periods
  • Edema

Serious side effects include:

  • Skin infections
  • Peeling
  • Sun-sensitivity to drugs
  • Hearing impairment
  • Hepatitis

Rarely, isotretinoin can cause brain swelling (pseudotumor cerebri or intracranial hypertension), which produces nausea, vomiting, headache, and changes in vision.

Erythema multiforme and severe skin reactions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been associated with isotretinoin use. These events may be serious and result in life-threatening events or death, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and isotretinoin discontinued if necessary.

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Reviewed on 9/8/2016 References Reference: FDA Prescribing Information

Accutane Description

Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg iron oxide (red) and titanium dioxide; 20 mg FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:

How is Accutane Supplied

Soft gelatin capsules, 10 mg (light pink), imprinted Accutane 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0155-49).

Soft gelatin capsules, 20 mg (maroon), imprinted Accutane 20 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0169-49).

Soft gelatin capsules, 40 mg (yellow), imprinted Accutane 40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0156-49).

Storage

Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.

Accutane Overview

Accutane is a prescription medication used to treat the most severe form of acne called nodular acne. Accutane belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.

This medication comes in capsule form and is usually taken twice daily, with food. Accutane may be taken for four or five months. A longer periods of use is not recommended.

Common side effects of Accutane include dry skin, chapped lips, dry eyes, or dry nose causing nosebleeds. Accutane can also cause birth defects, miscarriages, or premature births.

Because Accutane can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.

Uses of Accutane

Accutane is a prescription medication used to treat severe from of acne (nodular acne) that has not responded to other treatments.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Other Requirements

  • Store at room temperature
  • Protect from light.
  • Keep Accutane and all medicines out of the reach of children.
  • Acne (Pimples)
  • Boils (Skin Abscesses)

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

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]

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

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]

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

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]

Some side effects of Accutane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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