Potential Side Effects of ACCUTANE™
Potential serious side effects of ACCUTANE
- Pregnancy and ACCUTANE
Warning: Before you decide to take ACCUTANE, you must have discussed the consequences of becoming pregnant during ACCUTANE therapy with your doctor, and clearly understood them.ACCUTANE can cause deformed babies, loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. There is an extremely high risk that your baby will be deformed if you are pregnant while taking ACCUTANE, or become pregnant up to one month after treatment has stopped. This risk exists even if ACCUTANE is taken for a short time.If you are a female of childbearing age, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking ACCUTANE.
Click here to learn more about pregnancy prevention
- Mental health problems, suicide and ACCUTANE
Some patients while taking or soon after stopping ACCUTANE have become depressed or developed other serious mental health problems.Some patients taking ACCUTANE have had thoughts about putting an end to their own lives (suicidal thoughts), tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on ACCUTANE becoming aggressive or violent.If you become depressed or have any serious mental problems tell your doctor immediately. It may be necessary to stop ACCUTANE treatment.
- Serious skin reactions and ACCUTANE
Some patients taking ACCUTANE have had serious skin reactions, such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) which can result in hospitalization, disability and/or death.Stop using ACCUTANE and call your doctor immediately if you develop a serious skin reaction with symptoms such as blisters, peeling skin, severe red/purple rash, multiple lesions and sores, particularly in your mouth, nose, eyes and genitals, as well as facial and tongue swelling.
Potential common side effects of ACCUTANE (References: Current ACCUTANE Product Monograph, CHEPLAPHARM Schweiz GmbH)
If you have any of the following reactions while you’re taking ACCUTANE, let your doctor know about it at your next visit, or even sooner if it becomes too uncomfortable.
| What you can expect | What you can do |
| Chapped lips | Apply a specially formulated lip ointment to moisten and soften your lips. |
| Dry nose | Apply a nasal lubricant to avoid nosebleeds. Use a humidifier in your bedroom. |
| Peeling of the palms and soles | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Itchy skin, dry skin | Apply a non-irritating water-based moisturizer that won’t clog your pores. To help reduce further drying, wash your face with a non-irritating, water-based cleanser. |
| Dry mouth | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Redness of the face | Apply a non-irritating water-based moisturizer that won’t clog your pores. To help reduce further drying, wash your face with a non-irritating, water-based cleanser. |
| Hair thinning | In most cases, hair thinning is temporary, but tell your doctor because he/she may need to change your dosage. In a very small number of cases, hair thinning may be permanent. |
| Increased sensitivity to the sun | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Sunburn | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Inflammation of the lips | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Facial or body rash | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Mild nose bleed | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Bleeding/inflammation of gums | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Easily injured skin | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Increased fatigue | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Redness, dryness or irritation of the eyes | See your doctor. He/she may need to adjust your ACCUTANE dosage. |
| Dry eyes | Use an artificial tears product. If you wear contact lenses, choose a product that’s compatible with your contacts. |
How to report a suspected side effect
You can report any suspected adverse reactions associated with the use of health products by contacting the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789 or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
Questions or concerns about taking ACCUTANE?
Talk to your doctor or call 1-888-XEDITON (933-4866).
© CHEPLAPHARM Schweiz GmbH. All Rights Reserved. AcneandU.ca is a service provided by CHEPLAPHARM Schweiz GmbH.
© CHEPLAPHARM Schweiz GmbH. All Rights Reserved. AcneandU.ca is a service provided by CHEPLAPHARM Schweiz GmbH.
This website is neither intended nor designed to record or report adverse event information. If you have a suspected side effect or problem to report, please report adverse events to Health Canada directly by going to the Canada Vigilance Program website at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html.
This material is provided by Cheplapharm Schweiz GmbH, as part of the risk minimization plan for ACCUTANE. This material is not intended for promotional use.