
isotretinoin
Isotretinoin (Accutane) is a retinoid medication used to treat severe acne in people 12 years and older when other acne treatments, including antibiotics, haven't worked. You take a capsule by mouth twice a day, usually for about 4 to 5 months at a time. Common side effects include dry lips, dry skin, back pain, and dry eye. Because isotretinoin (Accutane) can cause serious birth defects, it's only available through the special safety program called iPLEDGE.
What is Isotretinoin (Accutane)?
What is Isotretinoin (Accutane) used for?
- Severe nodular acne that hasn’t improved with other acne treatments, including antibiotics
How Isotretinoin (Accutane) works
Isotretinoin (Accutane) is a retinoid, which is a type of vitamin A. It works by lowering the amount of oil your skin makes, which helps prevent clogged pores and clear acne. It also helps your skin renew itself more quickly and reduces inflammation.
Drug facts
| Common Brands | Accutane |
|---|---|
| Drug Class | Retinoid |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
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Side effects of Isotretinoin (Accutane)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Dry lips
- Dry skin
- Back pain
- Dry eyes
- Joint pain
- Nose bleeds
- Headache
- Upper respiratory tract infection
- Skin reactions
- Muscle problems
- Vision problems
Less Common Side Effects
- Hair loss
- Tiredness
- Dizziness
- Irritability
- Weight changes
- Poor appetite
- Ringing in the ears
- Nausea
- Diarrhea
- Swelling
- Sexual problems
Isotretinoin (Accutane) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Mental health changes: depression, mood changes, suicidal thoughts and behavior
- Higher pressure in the brain: bad headache, blurred vision, dizziness, nausea, vomiting, seizures, stroke
- Serious skin problems: pink eye, rash with a fever, blisters, sores, skin peeling
- Inflammation of the pancreas: severe upper stomach pain, stomach swelling, nausea, vomiting, fever
- Hearing problems: ringing in the ears, hearing loss
- Liver damage: yellowing of the skin or eyes, pain on the right side of the stomach, dark urine, bleeding or bruising more easily
- Inflammation of the gut: severe stomach or bowel pain, nausea, vomiting, trouble swallowing, heartburn, diarrhea, rectal bleeding
- Vision problems: trouble seeing at night, blurred vision
- Serious allergic reactions: swelling of the face or mouth, trouble breathing, fever, rash
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The following Isotretinoin (Accutane) side effects have also been reported
Along with its needed effects, a medicine 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:
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
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
bloody cough
bloody or cloudy urine
bone tenderness or aching
burning or stinging of the skin
confusion
continuing ringing or buzzing, or other unexplained noise in the ears
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
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
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
Some side effects 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
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
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Isotretinoin (Accutane)
Pros
- Works very well to treat severe acne
- Only need to take for 4 to 5 months for each treatment
- Can provide long-lasting results
- Available as a capsule you take by mouth
Cons
- Not safe in pregnancy
- Requires monthly monitoring and iPLEDGE participation
- Commonly causes dry skin and lips
- Can cause serious mental health changes
Pharmacist tips for Isotretinoin (Accutane)
- Take isotretinoin (Accutane) with a high-fat meal. This helps your body absorb the medication so it works better.
- Your acne might look worse at first before it gets better. Keep taking it as prescribed, and talk with your prescriber if your progress concerns you.
- If you miss a dose of isotretinoin (Accutane), skip it and take your next dose at the usual time. Don’t take two doses at once.
- Isotretinoin (Accutane) can make your skin more sensitive to the sun. Wear sunscreen and protective clothing when going out, and avoid tanning beds.
- Be careful driving at night while taking isotretinoin (Accutane). That's because it can affect your vision, especially in low light.
- You might need regular blood tests while taking isotretinoin (Accutane). These tests help check for side effects, such as liver problems or high cholesterol.
- Though not common, isotretinoin (Accutane) can affect your mood or thoughts. Stop taking the medication and call your care team if you feel depressed or have thoughts of self-harm.
- Check with your prescriber before taking any new medications, vitamins, or supplements with isotretinoin (Accutane). Some products, including vitamin A) can interact with isotretinoin (Accutane) and be dangerous for you. St. John’s wort can make hormonal birth control less effective, which can put you at risk for getting pregnant.
- Isotretinoin (Accutane) has several important interactions that can cause serious side effects. Don't take it with tetracycline antibiotics because the combination can raise pressure in the brain. And certain seizure medications can affect how well hormonal birth control works.
- Avoid alcohol while taking isotretinoin (Accutane) because the combination can raise your risk for liver damage.
- Don't donate blood while taking isotretinoin (Accutane) and for 1 month after your last dose. The medication could harm an unborn baby if a pregnant person receives your donated blood.
- Pregnancy: Because isotretinoin (Accutane) can cause serious birth defects, you must register with a special REMS program called iPLEDGE — even if you can't get pregnant.
Pregnancy prevention tips:
- Use two forms of birth control while taking isotretinoin (Accutane). This medication can cause severe birth defects. Talk to your prescriber about appropriate forms of birth control.
- You must not get pregnant for 1 month before starting, during treatment, and 1 month after stopping isotretinoin (Accutane). Your care team will require regular pregnancy tests during treatment.
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Risks and warnings for Isotretinoin (Accutane)
Isotretinoin (Accutane) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Harm to unborn baby
Isotretinoin (Accutane) can cause severe harm to unborn babies, including birth defects, miscarriage, and premature birth. Because of this risk, isotretinoin (Accutane) is only available through a special Risk Evaluation and Mitigation Strategies (REMS) program called iPLEDGE. You, your prescriber, and your pharmacy must all be enrolled in the program.
If you can get pregnant, you must use two forms of birth control for 1 month before starting treatment, during treatment, and for 1 month after your last dose. You'll also need regular pregnancy tests while taking the medication.
Don't donate blood while taking isotretinoin (Accutane) or for 1 month after your last dose. The medication could be passed to a pregnant person through a blood transfusion and harm their unborn baby.
Depression and thoughts of self-harm
Isotretinoin (Accutane) might affect your mood, thoughts, or behavior. In rare cases, people taking this medication reported depression, delusions, hallucinations, aggressive behavior, and suicidal thoughts or behavior. Stop taking the medication and contact your prescriber right away if you or your loved ones notice depression, unusual mood changes, aggressive behavior, or thoughts of self-harm.
Higher pressure in the brain
- Risk factors: Taking tetracycline medications
Isotretinoin (Accutane) can cause high pressure in the brain. Your risk is higher if you take certain antibiotics called tetracyclines at the same time, so this combination should be avoided.
Tell your care team right away if you have symptoms like severe headache, nausea, vomiting, or changes in your vision while taking isotretinoin (Accutane). You might need to stop the medication and get medical care right away.
Serious skin reaction
Isotretinoin (Accutane) can rarely cause severe skin reactions that could be life-threatening, such as Stevens-Johnson syndrome (SJS). These reactions can cause a widespread rash, blisters, peeling skin, or sores in your mouth, eyes, or other areas.
Stop taking the medication and get medical help right away if you notice a severe rash, blistering, peeling skin, or other unusual skin changes. Your care team might tell you to stop the medication permanently.
Inflammation of the pancreas
Isotretinoin (Accutane) can rarely cause pancreatitis, which is inflammation of the pancreas. Stop taking the medication and get medical help right away if you have severe stomach pain, nausea, or vomiting. These can be signs of pancreatitis and need prompt treatment.
High cholesterol and triglycerides
- Risk factors: Diabetes | Larger body size | Drinking alcohol regularly | History of high cholesterol or triglycerides
Isotretinoin (Accutane) can raise the amount of cholesterol and triglycerides. Tell your care team if you have diabetes, have a larger body size, or drink alcohol regularly, since these can increase your risk.
Your prescriber might order blood tests regularly to check your cholesterol and triglyceride levels. If your levels become too high, they might lower your dose or have you stop the medication.
Hearing problems
Isotretinoin (Accutane) can rarely cause hearing problems. In some cases, hearing loss has continued even after people stopped taking the medication.
Stop taking the medication and contact your care team right away if you notice ringing in your ears (tinnitus) or changes in your hearing. They might refer you to a hearing specialist for further testing.
Liver problems
Isotretinoin (Accutane) can lead to liver problems. Your care team will likely order blood tests before and during treatment to check how well your liver is working. If your liver tests become too high or you develop signs of liver damage, your prescriber might lower your dose or stop
Tell your care team right away if you notice yellowing of your skin or eyes, dark urine, pain in the upper right side of your stomach, or unusual tiredness. These can be signs of liver problems.
Inflammation of the gut
Isotretinoin (Accutane) has been linked to inflammatory bowel disease (IBD), even in people who have never had stomach or intestinal problems before. In some cases, symptoms continued after the medication was stopped.
Stop taking it and contact your care team right away if you have severe stomach pain, severe diarrhea, or bleeding from your rectum. These can be signs of a serious gut problem.
Bone and muscle problems
- Risk factors: Bone conditions | Anorexia | Taking seizure medications or corticosteroids | Take corticosteroid medications | Taking multiple courses of isotretinoin (Accutane)
Isotretinoin (Accutane) can affect your bones, joints, and muscles. Some people have had bone loss, broken bones, slower healing after a fracture, or changes in bone growth while taking this medication. The risk is higher if you have certain bone conditions, take steroid medications, or have taken multiple courses of the treatment.
Joint pain, muscle aches, and back pain are also common side effects. Tell your care team if you have ongoing back pain, joint pain, or trouble with physical activity while taking isotretinoin (Accutane). They might want to check for bone or joint problems.
If you play sports or do activities with repeated impact, let your care team know. In rare cases, the medication can increase the risk of certain bone and growth plate injuries in growing children and teens.
Eye problems
- Risk factors: History of eye problems
Isotretinoin (Accutane) can cause vision changes. Tell your care team right away if you notice blurry vision, trouble seeing, or any other changes in your eyesight. You might need an eye exam and may need to stop the medication.
Isotretinoin (Accutane) can also make it harder to see at night. In some cases, this problem has continued after treatment ended. Be extra careful when driving or doing other activities at night.
Dry eyes are a common side effect of the medication. If you wear contact lenses, they could feel uncomfortable during treatment.
Serious allergic reactions
It's rare, but isotretinoin (Accutane) can cause serious allergic reactions. These can include severe rash, bruising, red or purple spots on the skin, or swelling. Stop taking the medication and get help right away if you develop a severe rash, swelling, trouble breathing, or other signs of an allergic reaction.
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Isotretinoin (Accutane) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 10mg | 30 capsules | $57.46 | $1.92 |
| 20mg | 30 capsules | $50.04 | $1.67 |
| 30mg | 30 capsules | $57.46 | $1.92 |
| 40mg | 60 capsules | $89.12 | $1.49 |
Typical dosage for Isotretinoin (Accutane)
Your dose of isotretinoin (Accutane) is based on your body weight.
In general, the typical dose is 0.5 mg/kg to 1 mg/kg each day, split into 2 doses taken by mouth for 15 to 20 weeks (about 4 to 5 months). If needed, your prescriber might recommend a second course of treatment, but not until at least 2 months after your first course ends.
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Interactions between Isotretinoin (Accutane) and other drugs
More on Isotretinoin (Accutane) interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chlortetracycline
- Demeclocycline
- Desogestrel
- Dienogest
- Doxycycline
- Drospirenone
- Eravacycline
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Gestodene
- Levonorgestrel
- Lymecycline
- Meclocycline
- Medroxyprogesterone
- Mestranol
- Methacycline
- Minocycline
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Omadacycline
- Oxytetracycline
- Rolitetracycline
- Sarecycline
- Segesterone
- Tetracycline
- Tigecycline
- Ulipristal
How much does Isotretinoin (Accutane) cost?
$50.04
Isotretinoin (Accutane) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Isotretinoin (Accutane) will not be safe for you to take.
- Pregnancy
What are alternatives to Isotretinoin (Accutane)?
Doxycycline monohydrate is used to treat many different infections caused by bacteria. Some examples include:
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