isotretinoin
Isotretinoin is used to treat nodular acne that can't be cleared up by other acne treatments, including antibiotics. It's taken by mouth twice daily, typically for 4 to 5 months at a time. Because of the risk of serious birth defects, people who can get pregnant need to take pregnancy tests and use birth control before, during, and after treatment. Some common side effects include dry lips, dry skin, back pain, and dry eye. While isotretinoin is no longer available as brand name Accutane, you can still find it under other brands (e.g., Claravis and Amnesteem) and also as lower-cost generics.
What is Isotretinoin?
What is Isotretinoin used for?
Nodular acne that hasn't responded well to other treatments
How Isotretinoin works
Isotretinoin is a form of vitamin A. It works by lowering the amount of oil released by oil glands in your skin. Having less oil on your skin will help clear acne. It also helps your skin renew itself more quickly.
Drug Facts
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What are the side effects of Isotretinoin?
Common Side Effects
- Dry skin
- Worsening acne when first starting treatment
- Dry lips
- Chapped lips or swelling of the lips
- Dry eyes
- Eye problems, including blurry vision
- Back pain
- Joint pain
- Nose bleeds
- Headache
- Cold-like symptoms
Other Side Effects
- Hair loss
- Tiredness
- Changes in weight (loss or gain)
- Poor appetite
- Changes in heartbeat
- Ringing in the ears
Serious Side Effects
- Seizure
- Suicidal thoughts and behavior
- Higher pressure in the brain (pseudotumor cerebri): pressure in the head, headache, vision changes, nausea
- Stroke: dizziness, tiredness, feeling confused, blurry vision, trouble with speech, difficulty with balance, weakness or numbness on one side of the body
- Pancreatitis: upper stomach pain, fever, nausea, vomiting
- Liver damage: yellowing of skin or the whites of your eyes, pain on the right side of your stomach area, dark urine
- Serious skin reaction: skin pain, rash, fever, blisters, peeling skin
Source: DailyMed
More on Isotretinoin side effects
The following 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.
Pros and cons of Isotretinoin
Pros
Works well to clear your skin of severe acne when other treatments haven't worked as well
Most people experience clearer skin after just one course of treatment
Only need to take for 4 to 5 months for each treatment
Clearer skin can last for a while even after you've stopped taking isotretinoin
Cons
Can cause serious birth defects
Might be at higher risk of bone fractures if you play sports a lot
Can raise your blood sugar levels, and you might need to monitor your sugar levels more often
Not a good choice if you have a history of mental health problems, including depression, hallucinations, or suicidal thoughts
Pharmacist tips for Isotretinoin
Your skin might look worse at first before it gets better. Keep taking isotretinoin as prescribed to you, and discuss with your provider if your progress concerns you.
If you miss a dose, just skip that dose. Don't take two doses at the same time or extra doses.
Isotretinoin can make your skin more sensitive to sunlight. Wear sunscreen and protective clothing when going out. Avoid prolonged sun exposure and tanning beds.
You shouldn't drive at night until you know how isotretinoin affects your vision.
Your provider might order blood tests for you regularly while you're taking isotretinoin. This is because this medication can cause side effects such as higher cholesterol levels or liver problems. It's important that you go to your appointments because the test results can help your provider decide whether isotretinoin is still safe for you to take.
Though not common, isotretinoin can affect your thoughts and mood. Stop taking isotretinoin and call your healthcare provider if you notice signs and symptoms of depression or thoughts of self-harm.
Don't take other medications or herbal products unless you talk to your healthcare provider. Even certain vitamins (e.g., vitamin A) can interact with isotretinoin and be dangerous for you.
You shouldn't donate blood while taking isotretinoin and for 1 month after stopping the medication. Someone who's pregnant could receive your donated blood that still has the medication in it, which can cause birth defects in their unborn baby.
More tips for people who can get pregnant:
Use two forms of birth control while you're taking isotretinoin, because it can cause serious birth defects. Talk to your healthcare provider about appropriate forms of birth control.
You must not to get pregnant for 1 month before starting, during, and 1 month after treatment with isotretinoin. Your provider will require you to get pregnancy tests done throughout your treatment.
More on Isotretinoin tips
Frequently asked questions about Isotretinoin
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What are the risks and warnings for Isotretinoin?
Isotretinoin 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 can cause harm to unborn babies, such as birth defects, unexpected abortions, and premature births. Due to this risk, isotretinoin is only available through a special program (iPLEDGE) that you, your healthcare provider, and your pharmacy must sign up for. You can sign up for this program after discussing the risks and benefits with your healthcare provider. People who can get pregnant must use two forms of contraception (birth control) for 1 month before starting, during, and for 1 month after stopping treatment. You'll also need to have regular pregnancy tests while taking isotretinoin.
Depression and thoughts of self-harm
Risk factors: History of depression or other mental health condition
Isotretinoin can cause depression, delusions, hallucinations, aggressive behavior, and suicidal thoughts or behavior. Talk to your healthcare provider as soon as possible if you or anyone around you notice any unusual changes in your mood or behavior, especially during the first few months of treatment or when the dose changes.
Higher pressure in the brain
Risk factors: Taking tetracycline medications at the same time
Isotretinoin can raise the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Avoid taking or using any tetracycline antibiotics (e.g., minocycline, doxycycline, clindamycin) with isotretinoin, since this combination raises your risk. Call your healthcare provider right away if you experience bad headache, blurred vision, dizziness, nausea or vomiting, seizure, and stroke, as these might be signs of higher brain pressure.
Serious skin reaction
Isotretinoin can cause serious and life-threatening skin reactions, such as Stevens-Johnson syndrome (SJS). Go to the emergency room as soon as possible if you get a bad blistering rash all over your body with a very high fever and you can't breathe.
Inflammation of the pancreas
Inflammation of your pancreas (pancreatitis) can happen in people who take isotretinoin. Call your healthcare provider right away if you experience severe upper stomach pain, swelling of your stomach, nausea or vomiting, and fever. These might be signs of problems in your pancreas.
High cholesterol and triglycerides
Risk factors: Diabetes | Larger body size | Drinking alcohol regularly
Isotretinoin can raise the amount of cholesterol and triglycerides (a type of fat) in your blood. Your provider might order blood tests regularly to check your cholesterol and triglyceride levels. If your levels are too high, your provider might ask you to stop isotretinoin. These levels usually go back their normal range once you stop the medication.
Hearing problems
Stop using isotretinoin and call your healthcare provider if your hearing gets worse or if you hear ringing in your ears. Your hearing loss may be permanent, meaning it may continue even after stopping the medication.
Liver problems
Isotretinoin can lead to liver problems, like inflammation (hepatitis). Your healthcare provider will order lab tests to check that your liver is healthy before and during treatment with isotretinoin. Call your healthcare provider right away if you experience yellowing of your skin or the whites of your eyes, pain on the right side of your stomach, dark urine, and bleeding or bruising more easily than normal. These can be signs of liver damage.
Inflammation of the gut
In some rare cases, isotretinoin can cause inflammatory bowel disease in people without a history of stomach issues. People who have stomach pain, rectal bleeding, or severe diarrhea should stop isotretinoin right away and let their healthcare provider know.
Bone fractures and muscle pain
Risk factors: Weaker bones or bone-related conditions | Eating disorder called anorexia | Taking seizure medications or corticosteroids | Problems with vitamin D breakdown | Taking isotretinoin for a long time
Isotretinoin can cause muscle weakness, joint and bone pain, back pain, weakened bones, and bone fractures. The risk is higher if you are 65 years or older, currently have bone or joint problems, or are taking other medications that can weaken your bones. Talk to your provider about ways to stop bone fractures.
Eye problems
Risk factors: History of eye problems
Isotretinoin can worsen vision, dry the eyes, and make it harder to wear contact lenses. Be careful driving, especially at night, until you know how this medication affects you. If you notice changes in your vision, stop taking isotretinoin and get an eye exam as soon as possible.
More on Isotretinoin warnings
Isotretinoin dosage forms
Typical dosing for Isotretinoin
Your provider will determine your dose of isotretinoin based on your body weight.
In general, the recommended dose is 0.5 mg/kg to 1 mg/kg of body weight total daily, separated into 2 smaller doses that you take by mouth twice daily for 15 to 20 weeks (about 4 to 5 months). If needed, your provider might prescribe another round of treatment 2 months after your first round at the earliest.
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Interactions between Isotretinoin and other drugs
More on Isotretinoin interactions
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 cost?
Isotretinoin contraindications
Pregnancy
What are alternatives to Isotretinoin?
Nodular acne that hasn't responded well to other treatments
Lung infections (such as pneumonia)
Infections caused by ticks, mites, or fleas (Rocky Mountain spotted fever or typhus fever)
Sexually transmitted infections (STIs such as chlamydia, gonorrhea, or syphilis)
Urinary tract infections (UTIs)
Stomach infections
Severe acne
Anthrax
Plague
Cholera
Rosacea
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References
Best studies we foundAmerican Academy of Dermatology Association. (n.d.). Isotretinoin: The truth about side effects.
American Academy of Dermatology Association. (n.d.). What can clear severe acne?
Karaosmanoglu, N., et al. (2020). Analysis of musculoskeletal side effects of oral Isotretinoin treatment: a cross-sectional study. BMC Musculoskeletal Disorders.
National Institute of Neurological Disorders and Stroke. (2023). Pseudotumor cerebri.
Teva Pharmaceuticals USA, Inc. (2022). Claravis- isotretinoin capsule, liquid filled [package insert]. DailyMed.
U.S. Food and Drug Administration. (2021). Isotretinoin capsule information.
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