Isotretinoin Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 6, 2024.

Applies to isotretinoin: oral capsule, oral capsule liquid filled.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, check with your doctor right away.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant 1 month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.

Isotretinoin must not be taken by women of reproductive age who may become pregnant unless 2 effective forms of birth control have been used for at least 1 month before the start of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure that you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have 2 pregnancy tests before beginning treatment with isotretinoin to make sure you are not pregnant. The second pregnancy test must be taken at least 19 days after the first test and during the first 5 days of the menstrual period immediately before beginning treatment. In addition, you must have a pregnancy test each month while you are using this medicine and 1 month after treatment is completed.

Do not take vitamin A or any vitamin supplement containing vitamin A while using this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop using isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.

You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop using it. This is to prevent a pregnant patient from receiving blood that contains the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive or do anything else that could be dangerous until you know how this medicine affects you. Also, check with your doctor.

Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are using isotretinoin and for up to 2 weeks after stopping it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.

Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

To help isotretinoin to work properly, use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

This medicine may increase pressure in your head, which may lead to vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea, vomiting, or seizures.

Serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may also heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.

It is very important that you or your child not have any cosmetic procedures to smooth your skin (eg, dermabrasion, laser) while you are using isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Isotretinoin may cause some people to have hearing problems within a few weeks after they start using it. Check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you or your child have stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, redness, soreness, or itching skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine contains FD&C Yellow No.5 (tartrazine) which may cause an allergic reaction, including asthma, in some people. This reaction is more often seen in people who also have an allergy to aspirin.

This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (eg, St. John's wort) may cause your birth control pills to not work as well.

Serious side effects of isotretinoin

Along with its needed effects, isotretinoin 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 while taking isotretinoin:

Other side effects of isotretinoin

Some side effects of isotretinoin 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:

For healthcare professionals

Applies to isotretinoin: compounding powder, oral capsule.

General adverse events

The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).^[Ref]

Gastrointestinal

• Very common (10% or more): Cheilitis/dry lips (up to 90%)
• Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease
• Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums^[Ref]

Hematologic

• Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)
• Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis
• Rare (0.01% to 0.1%): Agranulocytosis
• Very rare (less than 0.01%): Lymphadenopathy
• Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts^[Ref]

Metabolic

• Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)
• Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein
• Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia
• Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein
• Postmarketing reports: Increased fasting blood glucose levels^[Ref]

Respiratory

• Very common (10% or more): Epistaxis (Up to 30%)
• Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis
• Very rare (less than 0.01%): Bronchospasm, dry throat
• Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration^[Ref]

Bronchospasm occurred in patients receiving treatment, especially in those with asthma.^[Ref]

Dermatologic

• Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma
• Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia
• Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue
• Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles
• Postmarketing reports: Bruising, seborrhea^[Ref]

In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks^[Ref]

Ocular

• Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation
• Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum
• Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation^[Ref]

Papilledema occurred as a sign of benign intracranial hypertension.^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels
• Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons
• Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain^[Ref]

Back pain occurred more frequently in children and adolescent patients.

Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.^[Ref]

Genitourinary

• Common (1% to 10%): Proteinuria, microscopic or gross hematuria
• Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness
• Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope^[Ref]

Hepatic

• Common (1% to 10%): Transient and reversible increased transaminase levels
• Very rare (less than 0.01%): Hepatitis
• Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin^[Ref]

Psychiatric

• Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations
• Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide
• Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders
• Postmarketing reports: Auditory hallucinations^[Ref]

Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
• Frequency not reported: Allergic reactions^[Ref]

Other

• Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise
• Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)
• Postmarketing reports: Infection^[Ref]

Cardiovascular

• Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
• Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing^[Ref]

Renal

• Very rare (less than 0.01%): Glomerulonephritis^[Ref]

See also:

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Further information

Isotretinoin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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