Precautions for the Safe Use of Isotretinoin (Accutane)
Dermatologists and Skin Care Data Verified

Precautions for the Safe Use of Isotretinoin (Accutane)

Written by
Dr. Suvash Sahu
and medically reviewed by iCliniq medical review team.

Published on Feb 09, 2018 and last reviewed on Nov 24, 2022   -  5 min read


If you are about to use Isotretinoin for severe acne, this article is for you. Get to know the precautions and risks associated with its usage. Scroll down to read how you can safely use Isotretinoin in detail.

Precautions for the Safe Use of Isotretinoin (Accutane)

What Is Isotretinoin?

Isotretinoin, a first-generation retinoid, is used for severe acne or pimples which have not responded to regular treatment. It acts by inhibiting sebum production, sebaceous proliferation, differentiation, decreasing sebaceous gland size, and downregulating the hormonal receptors in the skin responsible for the increased oil production. Also, they have antibacterial action (indirectly) and anti-inflammatory effects.

What Is Accutane?

Accutane is the derivative of the drug Isotretinoin. It is used to treat severe nodular acne. It is a retinoid that is similar to retinoic acid and retinol (vitamin A), which can treat many skin conditions.

How Is Acne Formed?

Acne is formed due to the overproduction of sebum in the skin by the sebaceous glands. It consists of wax, oils, and cholesterol. When used on acne, Accutane will inhibit the function and keratinization of the sebaceous gland and prevent acne formation.

When Should Accutane Be Administered?

Accutane is administered in severe nodulocystic acne, moderate acne not responding to antibiotics, rosacea, and hidradenitis suppurativa.

What Are The Dosage Forms Of Accutane?

Accutane is available in the dosage form of 10, 20, and 40 milligrams (mg) soft gel capsules, which should be taken by mouth. The dose recommended is typically 0.5 to 1 mg per kilogram (kg) of the bodyweight daily. It should be taken after food for its better absorption and twice a day for 15 to 20 weeks.

What Are The Risks Associated With Accutane?

Accutane can cause severe birth defects, so it should not be taken in case of pregnancy or if planning to become pregnant. If you have reproductive potential, it requires few indications to receive an Accutane prescription. It is necessary to take two contraceptives one month before, during the treatment, and one month after the drug use to prevent accidental conception and avoid birth defects in the future fetus.

Additionally, two pregnancy tests should be conducted, and it must be negative before you have been prescribed this drug. And every month, you should get a negative pregnancy test to continue receiving the prescription.

Severe congenital disabilities can occur with Accutane use while pregnant. Documented cases include:

  • Eye abnormalities.

  • Skull abnormalities.

  • Cardiovascular abnormalities.

  • Central nervous system abnormalities.

  • Thymus gland abnormality.

  • Parathyroid hormone deficiencies.

In some cases, it can also result in:

  • Spontaneous abortions.

  • Premature births.

  • Psychosis.

  • Depression.

  • Death.

  • Rarely, suicide attempts, suicidal ideation, and aggressive or violent behaviors can occur.

Therefore, before beginning the treatment with Accutane, consult with your doctor about any mental health history. And if you experience any mental health symptoms during the therapy, let your doctor know about it immediately. Signs of depression that can occur while taking Accutane include:

  • Fatigue.

  • Hopelessness.

  • Sad or depressed mood.

  • Feelings of worthlessness or guilt.

  • Restlessness or irritability.

  • Suicidal attempts or thoughts.

  • Difficulty concentrating.

  • Loss of interest in activities.

  • Loss of appetite.

  • Weight changes.

  • Changes in sleep patterns.

When Accutane is taken with the antibiotic Tetracycline, it can cause pseudotumor cerebri, a condition in which the pressure around your brain increases. Speak with your doctor if you develop symptoms like:

  • Headache.

  • Nausea and vomiting.

  • Papilledema (swelling of the optic nerve).

  • Visual disturbances.

What Are The Side Effects Of Accutane?

The side effects of Accutane include:

  • Skin rash.

  • Nosebleeds.

  • Bone or joint pain, or broken bones.

  • Dry lips, mouth, and skin.

  • Redness, itching, or burning of the eyes.

The severe side effects of Accutane include:

  • Stomach Problems: Organ damage can occur in the liver, pancreas, intestines, and esophagus. Acute pancreatitis can result from Accutane; therefore, seek immediate medical attention if you have severe abdominal pain, nausea, vomiting, chills, fever, or constipation.

  • Vision Problems: Accutane can make a person unable to see in the darkness. It can also cause dryness of the eyes, making wearing contact lenses difficult.

  • Hearing Problem: After the intake of Accutane, contact your doctor if there is ringing in the ears or if the hearing gets worse.

  • Blood Sugar Problems: It is important to monitor the blood sugar levels during therapy, especially if a person has diabetes, as the drug may affect them.

  • Lipid Problems: Accutane can increase the level of lipids in the blood. Therefore it is important to monitor the levels of fat and cholesterol.

  • Allergic Reactions: Inform your physician if you are allergic to any food dyes and seek medical attention if you develop a swollen face, hives, or have difficulty breathing to avoid any adverse effects.

  • Inflammatory Bowel Disease (IBD): It has been reported that patients had developed IBD while taking Isotretinoin. But still, there is no proper evidence to determine whether Isotretinoin is actually the cause. More research is required.

If a patient develops any of the following signs or symptoms of IBD, the patient must stop taking Isotretinoin and see a doctor:

  • Diarrhea.

  • Severe stomach or bowel (intestines) pain.

  • Bleeding from rectum.

  • Yellowing of skin or eyes.

  • Dark urine.

Can Accutane Make You Addictive?

Accutane is not addictive. Consult with your doctor if you have any doubts about the drug or for any alternate options available.

What Are The General Tips and Safety Information For the Administration Of Accutane?

1. Do not share these capsules with others even if their condition appears to be the same as yours.

2. This drug can cause mucosal and skin dryness. Vaseline is to be applied to prevent and treat mucosal and skin dryness. Besides this, many other adverse effects are known. But teratogenicity is the most important adverse effect in this. If a female on Isotretinoin gets pregnant, it can lead to malformation of the fetus' skull and face and can result in cardiovascular and CNS defects.

3. Avoid pregnancy by barrier methods or injectable hormonal contraceptives. Contraceptive precautions are advocated for one to three months after the stoppage of Isotretinoin.

4. Avoid direct sun exposure. Use sunscreen and take tablets at night to prevent phototoxicity. Initially, for the first 2 to 3 weeks of treatment, the skin might be more sensitive to wind, sun, and cold weather damage. Therefore, it is necessary to avoid exposing your skin to the sun by wearing protective clothing and hats.

5. An initial flare-up is possible. A course of systemic steroids can four weeks before Isotretinoin therapy can avoid flare-ups. A lag period of one to three months may exist before the onset of therapeutic effects of Isotretinoin.

6. Report to your treating doctor right away if you experience a severe headache, inability to concentrate, or alteration in mood.

7. Avoid taking other drugs that your dermatologist or physician does not advise.

8. Do not donate blood or semen during or up to one month after therapy.

9. Treatment with Isotretinoin need not be continued till the clearance of all acne lesions as improvement in acne lesions continues even after the stoppage of Isotretinoin.

10. Chances of relapse exist after an Isotretinoin therapy if the total cumulative dose is less than 120 mg/kg. No further benefit occurs if given a dosage of more than 150 mg/kg.

11. The most common laboratory abnormalities observed in a patient on oral retinoids like Accutane or Isotretinoin are elevated serum lipids. Besides this, other investigations like complete blood count with platelets and liver function tests need to be monitored every month for the first three to six months.

12. Serum or urine pregnancy test is indicated every month for women of childbearing potential (and at the end of therapy).


Isotretinoin is an important medicine that can clear severe acne that has not responded to any other treatment. When the acne clears up, a patient's quality of life will often greatly improve. Patient safety is the dermatologist's priority while prescribing Isotretinoin.

Frequently Asked Questions


Is Using Isotretinoin Reliable?

Although taking Isotretinoin is considered safe, it is a medication that requires close monitoring, so regular monthly checkups with the treating physician are necessary to observe the health and well-being of the individual under treatment. Complete blood count, lipid profile, and liver enzymes tests are taken at regular intervals to have a hold of the severe side effects.


Does Isotretinoin Treat Acne?

Isotretinoin helps in the successful treatment of acne and also helps in clearing away acne. Even acne, which does not respond to other types of therapy, can be cured by Isotretinoin. Therefore, it is considered an effective treatment in the case of prescription medicines.


What Is the Action of Isotretinoin?

The actual mechanism of action of Isotretinoin is unknown. It acts by reducing the size of the sebaceous gland, limiting sebum production, hampering the sebaceous gland's function, and inhibiting keratinization.


What Are the Adverse Effects of Isotretinoin?

Rashes, irritation, dry skin, dry lips, dry mouth, dry eyes, cracked skin, nosebleeds, inflammation of the eye whites, joint pain, backache, fatigue, nervousness, drowsiness, dizziness, etc., are the common side effects of taking Isotretinoin.


What Are the Effects of Isotretinoin in the Long Run?

- Decreased libido.
- Erectile dysfunction.
- Numbness in the genitals.
- Problems in the bones, muscles, ligaments, and joints.
- Damage to internal organs like the pancreas, intestines, liver, and esophagus.
- Rise in the blood sugar level.
- Night blindness.
- Steven-Johnson's syndrome.
- Toxic epidermal necrolysis.
- Erythema multiforme.
- Increased pressure in the brain leads to loss of vision and sometimes death.


Does Isotretinoin Cause Weight Gain?

The Food and drug administration of the United States has not reported a change in weight as a side effect. However, few people have reported weight gain and weight loss.


Can Isotretinoin Be Taken Forever?

Treatment with Isotretinoin is usually given for about 16 to 24 weeks. After which, the acne usually heals; however, few may require a second round of treatment.


Can Acne Return After Stopping Isotretinoin?

After treatment with Isotretinoin, acne usually does not recur. Using moisturizers and cleansers which do not contain oil and using skincare products that are non-comedogenic also help in reducing the risk of recurrence.


Can Isotretinoin Permanently Remove Acne?

Although with Accutane, acne cure is not guaranteed for the lifetime, most patients do not exhibit recurrence. It has been reported that in about one-third of people, recurrence of acne is seen.


Can Dark Spots Be Removed With Isotretinoin?

Previous scars caused by acne cannot be cured by Isotretinoin. Dermabrasion, carbon dioxide laser ablation therapy, or chemical peel help remove the spots, but it should be started only after six to twelve months of Isotretinoin treatment.


Can We Use Accutane for Mild Acne?

In case of mild to moderate acne, Isotretinoin should be cautiously used. If required, low doses on alternate days are the recommended safe treatment option.


After How Long Does Accutane Work?

It usually takes from about a week to ten days for the Isotretinoin capsules to exhibit their action. Most patients who take Isotretinoin show good results within four months of taking Isotretinoin.


How Many Days Does Accutane Last in the Body?

The half-life of Isotretinoin is 21 hours, and it takes about four to five days to be entirely excreted from the system. However, women are advised to start trying for conception only after a month of stopping Isotretinoin.


After How Many Days of Taking Accutane Waxing Can Be Done?

Isotretinoin brings about modifications in the structure and function of skin, thereby making them increasingly sensitive to any form of external stimuli. Since epidermal stripping can occur in these patients, waxing should be done only after six months of withdrawing Isotretinoin.


How Many Days After Accutane Can You Get a Tattoo?

As the skin becomes fragile, it is not advisable to get tattoos while taking Isotretinoin or until six months after completing the course of Isotretinoin.

Last reviewed at:
24 Nov 2022  -  5 min read




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