Common Side Effects Of Accutane (Isotretinoin) Drug Center, Decutan

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For Patients

Last reviewed on RxList 9/7/2016

Accutane (isotretinoin) is a retinoid used for the treatment and prevention of severe acne. The brand name Accutane is discontinued in the U. S. but generic formulations are available The most common side effects of Accutane are:

dry skin ,

itching ,

rash ,

dry nose,


cracks in the corners of the mouth,

dry mouth ,

dry lips,

cracking or peeling skin ,

inflammation of the whites of the eyes,

dry eyes ,

joint pain ,

back pain ,

dizziness ,


nervousness, or

changes in your fingernails or toenails.

The recommended dose of Accutane is 0.5 to 2 mg per kg of body weight daily. Accutane may interact with steroids, seizure medications. or tetracycline antibiotics. Tell your doctor all medications and supplements you use. Combining vitamin A with Accutane may increase side effects. Accutane is harmful to the fetus and therefore should not be used during pregnancy. Accutane is harmful to the fetus and therefore should not be used during pregnancy. It is unknown if Accutane passes into breast milk. Consult your doctor before breastfeeding .

Our Accutane Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Accutane in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;

sudden numbness or weakness, especially on one side of the body;

blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;

hearing problems, hearing loss, or ringing in your ears;

seizure (convulsions);

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

severe diarrhea, rectal bleeding, black, bloody, or tarry stools;

fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;

severe blistering, peeling, and red skin rash; or

joint stiffness, bone pain or fracture.

Less serious side effects may include:

joint pain, back pain;

feeling dizzy, drowsy, or nervous;

dryness of the lips, mouth, nose, or skin; or

cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Accutane (Isotretinoin)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Accutane Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have any of these unlikely but serious side effects: mental/mood changes (e. g. depression, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling feeling in the skin, quick/severe sunburn (sun sensitivity), back/joint/muscle pain, signs of infection (e. g. fever, persistent sore throat), painful swallowing, peeling skin on palms/soles.

Isotretinoin may infrequently cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting.

Stop taking this medication and tell your doctor immediately if you develop these unlikely but very serious side effects: severe headache, vision changes, ringing in the ears, hearing loss, chest pain, yellowing eyes/skin, dark urine, severe diarrhea, rectal bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Accutane (Isotretinoin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Accutane FDA Prescribing Information: Side Effects (Adverse Reactions)


Clinical Trials and Postmarketing Surveillance

The adverse reactions listed below reflect the experience from investigational studies of Accutane (isotretinoin). and the postmarketing experience. The relationship of some of these events to Accutane (isotretinoin) therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Accutane (isotretinoin) are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, eg, of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS ).

Body as a Whole

allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS. Hypersensitivity ), edema. fatigue, lymphadenopathy. weight loss


palpitation, tachycardia. vascular thrombotic disease, stroke


hypertriglyceridemia (see WARNINGS. Lipids ), alterations in blood sugar levels (see PRECAUTIONS. Laboratory Tests )


inflammatory bowel disease (see WARNINGS. Inflammatory Bowel Disease ), hepatitis (see WARNINGS. Hepatotoxicity ), pancreatitis (see WARNINGS. Lipids ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea. other nonspecific gastrointestinal symptoms



skeletal hyperostosis. calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density (see WARNINGS. Skeletal ), musculoskeletal symptoms (sometimes severe) including back pain, myalgia. and arthralgia (see PATIENT INFORMATION ), transient pain in the chest (see PATIENT INFORMATION ), arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS. Laboratory Tests ).



suicidal ideation, suicide attempts, suicide, depression. psychosis. aggression, violent behaviors (see WARNINGS. Psychiatric Disorders ), emotional instability

Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System


bronchospasms (with or without a history of asthma), respiratory infection, voice alteration

Skin and Appendages

acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth. dry nose, dry skin. epistaxis. eruptive xanthomas, 7 erythema multiforme. flushing, fragility of skin, hair abnormalities, hirsutism. hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia. peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus. pyogenic granuloma, rash (including facial erythema, seborrhea. and eczema), Stevens-Johnson syndrome. sunburn susceptibility increased, sweating. toxic epidermal necrolysis, urticaria. vasculitis (including Wegener's granulomatosis; see PRECAUTIONS. Hypersensitivity ), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PATIENT INFORMATION )

Special Senses

Vision - corneal opacities (see WARNINGS. Corneal Opacities ), decreased night vision which may persist (see WARNINGS. Decreased Night Vision ), cataracts, color vision disorder, conjunctivitis. dry eyes, eyelid inflammation, keratitis. optic neuritis, photophobia. visual disturbances

Urinary System

glomerulonephritis (see PRECAUTIONS. Hypersensitivity ), nonspecific urogenital findings (see PRECAUTIONS. Laboratory Tests for other urological parameters)


Elevation of plasma triglycerides (see WARNINGS. Lipids ), decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment

Increased alkaline phosphatase. SGOT (AST), SGPT (ALT), GGTP or LDH (see WARNINGS. Hepatotoxicity )

Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS. Laboratory Tests ), hyperuricemia

Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PATIENT INFORMATION ), elevated sedimentation rates, elevated platelet counts, thrombocytopenia

Read the entire FDA prescribing information for Accutane (Isotretinoin)