Accutane may cause serious mental health problems including: depression, psychosis (seeing or hearing things that are not real) and suicide.

ABOVE: Roche Laboratories Inc., "Accutane Medication Guide," rev. 8/05.
Accutane bottles

Accutane has a long history of controversy over birth defects, depression and suicide, and other serious medical problems.

Accutane Side Effects and Warnings

  • Generic name: Isotretinoin
  • Brand names: Accutane, Amnesteem, Claravis, Decutan, Isotane, Sotret, Oratane, Roaccutane

Common Reactions to Accutane

  • Pain and swelling of the lips
  • Severe itching
  • Alopecia (hair-thinning/hair-loss/baldness)
  • Fragile and weaker skin
  • Vision problems
  • Decreased night vision (onset may be sudden)
  • Conjunctivitis (pink eye)
  • Contact lens intolerance
  • Dry mucous membranes (dry nose, lungs, bladder, anus)
  • Peeling skin on palms/soles
  • Nail changes
  • Nosebleeds
  • Photosensitivity (sensitivity to light)
  • Elevated triglycerides in the blood
  • Elevated liver enzymes (indicating liver damage)
  • Tinnitus (ringing in ears or buzzing in ears)
  • Joint pain and muscle pain
  • Back pain
  • Depression

Serious Reactions to Accutane

  • Depression
  • Erectile dysfunction (difficulty in maintaining erection)
  • Violent behavior/aggression
  • Psychosis (seeing or hearing things that are not real)
  • Suicidal ideation (rare)
  • Suicide attempts
  • Hearing impairment
  • Pseudotumor cerebri (swelling pressure in the brain)
  • Osteopenia/osteoporosis (loss in bone mass and strength/weak and fragile bones)
  • Hepatotoxicity (liver damage)
  • Anaphylaxis (rapid and deadly allergic reaction)
  • Allergic vasculitis (inflammation and damage to blood vessels)
  • Major birth defects
  • Cataracts/corneal opacities (can cause a decrease in vision and lead to eventual blindness)
  • Premature epiphyseal closure (short stature)
  • Neutropenia (low white blood cell count, which makes the body vulnerable to bacterial and fungal infections)
  • Agranulocytosis (a serious condition in which white blood cells decrease in number or disappear altogether) (rare)
  • Rhabdomyolysis (potentially fatal disease that destroys skeletal muscle) (rare)
  • Inflammatory bowel disease (inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea)
  • Pancreatitis (inflammation of the pancreas, an organ important in digestion)
  • Vascular thrombosis (heart attack)
  • Stroke
  • Seizures

Accutane (isotretinoin) is Used for

A two-year U.S. congressional investigation found that many dermatologists have effectively widened the scope of Accutane use to include even mild acne despite the fact that the drug is approved for only the most severe, scar-forming and disfiguring nodular acne, which is untreatable by other means. The government found that 90 percent of women and nearly half the teens who received Accutane suffered only mild cases of acne. Therein lies the controversy surrounding this high-risk drug.

The Power of Accutane: Benefits and Risks

Accutane is a very powerful drug that certainly works miracles to clear up acne in a matter of months. One course, which is typically five months, results in prolonged remission of acne in up to 85 percent of patients. "But as powerful as Accutane can be in improving patients' lives, the adverse effects can be just as powerful," states FDA Consumer magazine. "The drug is known to cause miscarriage and severe birth defects. Patients taking Accutane may develop potentially serious problems affecting a number of organs, including the liver, intestines, eyes, ears, and skeletal system. And some patients taking Accutane have developed serious psychiatric problems."

Many former Accutane users say their hair, eyebrows, or eyelashes have fallen out months, or even years, after stopping the drug. Some claim their hair loss is permanent.

Why does Accutane hair-loss happen? Accutane impacts the oil-gland function of the skin (including the scalp) and causes changes in cells that provide structure to hair and skin, all of which leads to hair and skin dryness and fragility, which can cause hair-thinning, hair-loss, and even baldness.

Current and former Accutane users attribute aches and joint pains to the acne drug. A 37-year-old nurse with cystic acne claims Accutane caused her to develop permanent, severe low-back pain, severe joint pain and thinning hair. She writes: "Now, almost 7 years later, I suffer from severe back and generalized joint pain to the point I can no longer work full-time. Before Accutane, I was a healthy, active young woman. It definitely ages you prematurely. If you haven't had these awful symptoms, count yourself blessed."

Experts agree that alternatives without serious side effects should be tried first.

How Accutane Works

Accutane inhibits the body's cell growth and reproduction, and oil-gland function.

Accutane also depletes the body's water-holding molecules, which bind, lubricate and protect tissue in the skin, scalp, eyes and joints.

Accutane (isotretinoin) is the first drug in the history of medicine for which a woman has to sign a consent to read the warnings.

FDA "Black Box" Warning

The Food and Drug Administration (FDA) requires the following "black box" warning on isotretinoin, including Accutane, Amnesteem, Claravis, and Sotret, which means that medical studies indicate these drugs carry a significant risk of serious, or even life-threatening, adverse effects.


Accutane causes birth defects Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.

ABOVE: Roche Lab. Inc., Accutane Packge Insert, rev. 10/07.

Dosage Forms of Accutane (Isotretinoin)

EACH CAPSULE (Active Ingredient: Isotretinoin)
Accutane 10 mg 20 mg 40 mg contains soybean oil and parabens*
Amnesteem 10 mg 20 mg 40 mg contains soybean oil
Claravis 10 mg 20 mg 40 mg contains soybean oil
Sotret 10 mg 20 mg 40 mg contains soybean oil and parabens*

*Accutane contains parabens, which are chemical preservatives known to display estrogenic activity and mimic the body's hormones. These chemical-disruptors may interfere with the body�s endocrine system: the adrenal glands, the pituitary gland, the hypothalamus (in the brain), the thyroid, the ovaries and testes, the pancreas (which secretes insulin and regulates the level of glucose in the blood), the stomach, the kidneys, the skin and virtually every body system.

A blinded, randomized study was conducted to determine whether vitamin E would reduce the toxicity and side effects of Accutane and the results showed that vitamin E does not.

ABOVE: Kus, S., et al. "Vitamin E does not reduce the side-effects of isotretinoin in the treatment of acne vulgaris." Int J Dermatol 2005;44(3):248-51.

A Completely Safe, Non-Drug Natural Approach

Flavay® rebuilds collagen, improves circulation and health in skin cells, and reduces inflammation; boosts the immune system with powerful antioxidant action; and Flavay Plus® can help improve concentration, attention and memory-raising cognitive performance.

[Click here for a Safe, Effective, Non-Drug Alternative]

  • Mitchell, S., "Hill committee: Accutane causes suicide." United Press International (UPI), 12/2002.
  • Meadows, M., "The Power of Accutane: The Benefits and Risks of a Breakthrough Acne Drug." FDA Consumer magazine, 3-4/2001.
  • (post date: 2/28/2008).
  • Physicians' Desk Reference (PDR), 58th ed. Montvale, NJ: Thomson PDR, 2004.
  • Roche Laboratories Inc., "Accutane Medication Guide," rev. 8/05.
  • Roche Laboratories Inc., Accutane pkg. labeling, rev. 8/05.
  • Barr Laboratories Inc., "Claravis Medication Guide," rev. 3/06.
  • Mylan Pharmaceuticals Inc., "Medication Guide Amnesteem," rev. 8/05.
  • Ranbaxy Laboratories Inc., "Medication Guide Sotret," rev. 8/05.
  • Fried, S.M. Bitter Pills: Inside the Hazardous World of Legal Drugs. New York, NY: Bantam Books, 1998.
  • March of Dimes Fact Sheet, "Accutane and Other Retinoids," rev. 10/05.
  • University of Maryland Medical Center, "Isotrerinoin." American Accreditation HealthCare Commission, 2007.
  • Tirado Sanchez, A, et al. (Nov-Dec 2005). "Erectile dysfunction during isotretinoin therapy". Actas urologicas espa�olas. 29 (10): 974-6.
  • U.S. Environmental Protection Agency, Daughton, C.G. et al., "Special Report: Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?" Environmental Health Perspectives, vol. 107 sup. 6: National Institute of Environmental Health Sciences, 12/99. As reported by the Organic Consumers Association, 07/04.
  • Kus, S., et al. "Vitamin E does not reduce the side-effects of isotretinoin in the treatment of acne vulgaris." Int J Dermatol 2005;44(3):248-51.
Flavay for Healthier, Smoother Skin Throughout Your Entire Body: Click here for a Safe, Effective, Non-Drug Alternative

VERY SEVERE BIRTH DEFECTS have occurred with Accutane use including:

Illustration of very severe birth defects caused by Accutane: skull shape, small chin, enlarged skull, deformed or missing ears
  • Severe Internal Defects: defects that you cannot see--involving the brain (including lower IQ scores), heart, glands and nervous system.
  • Severe External Defects: defects that you can see--such as low-set, deformed or absent ears, wideset eyes, depressed bridge of nose, enlarged head and small chin.
ABOVE: Roche Lab. Inc., Accutane pkg. labeling, rev. 8/05.

Read the Medication Guide that comes with Accutane before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about ACCUTANE?

  • Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
  • Because Accutane can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
  • Accutane may cause serious mental health problems.

1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:

  • for 1 month before starting Accutane
  • while taking Accutane
  • for 1 month after stopping Accutane.

If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

  • FDA MedWatch at 1-800-FDA-1088, and
  • the iPLEDGE pregnancy registry at 1-800-495-0654

2. Serious mental health problems. Accutane may cause:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.

Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptom of depression or psychosis:

  • start to feel sad or have crying spells
  • lose interest in activities you once enjoyed
  • sleep too much or have trouble sleeping
  • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • have a change in your appetite or body weight
  • have trouble concentrating
  • withdraw from your friends or family
  • feel like you have no energy
  • have feelings of worthlessness or guilt
  • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  • start acting on dangerous impulses
  • start seeing or hearing things that are not real

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

ABOVE: Roche Laboratories Inc., "Accutane Medication Guide," rev. 8/05.

Adderall XR Side Effects

In small doses amphetamines can banish tiredness and make the user feel alert and refreshed. However, the burst of energy comes at a price. A "speed crash" always follows the high and may leave the person feeling nauseous, irritable, depressed and extremely exhausted. [More]

What is Your Adderall IQ?

Amphetamine Advantage or Dangerous Delusion?

Like athletes who use steroids, students who use Adderall to enhance academic performance are in many ways victims. [More]

Vyvanse is a “Pro-Drug”

Although Vyvanse is referred to as “pro-drug” of dextroamphetamine, it is still an amphetamine, meaning that it is easily abused and can cause insomnia, agitation, axiety and sometimes psychotic symptoms like seeing things or becoming paranoid. [More]

Strattera Side Effects

Most people may not know that Strattera (atomoxetine) appears to cause unsatisfactory sexual function (decreased libido, ejaculatory problems and impotence). [More]

Flavay for Healthier, Smoother Skin Throughout Your Entire Body: Click here for a Safe, Effective, Non-Drug Alternative

A Completely Safe, Non-Drug Natural Approach to Healthier and Beautiful Skin

Flavay® rebuilds collagen, improves circulation and health in skin cells, and reduces inflammation; boosts the immune system with powerful antioxidant action; and Flavay Plus® can help improve concentration, attention and memory-raising cognitive performance.

"This stuff really, really works! I have been taking Flavay® for about two months and my acne has really cleared up. Nothing dermatologists gave me helped. I am so glad I found Flavay®!"
—Ms. Eileen H.

"After taking Accutane my 15-year-old son's acne just got worse. He just completed his first bottle of Flavay® and the results are fantastic!"
—Ms. Linda A.

"Since I have been taking Flavay® my acne is so much better. I wanted to try something natural before taking Accutane and I am glad that I did. Thank you for your information."
—Ms. Kathy C.

"At 50 years of age I had come up with adult acne, with cysts and scabs all over my face. I've been taking 4 Flavay® and 4 Flavay Plus® capsules twice a day and in a two-week period my face is clear! The last scab came off my chin today...We own our own business and have been traveling a lot lately, under the stress of a busy schedule, and yet my face just kept clearing up and now it's clear!"
—Ms. D. G.

LEGAL DISCLAIMER: This website is for general information purposes only. Statements and excerpts from research literature are provided solely as a forum for commentary and specifically not as health or medical advice. Only your physician should diagnose your health problem and prescribe treatment. DO NOT CHANGE OR STOP TAKING MEDICATION BASED ON INFORMATION YOU READ AT THIS WEBSITE. If you have a question about a drug, or if you think you are experiencing a drug's side effect, consult with your doctor.
  • Copyright © 1995-2015 Research Publishing Co., LLC. All rights reserved. Use of this website constitutes acceptance of the Terms of Use.

Related Links

Resource Links