What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

blurred or distorted vision bone or joint pain chest pain decreased night vision dizziness drowsiness dryness of eyes, mouth, or nose dryness or itching of skin fatigue hair loss headache muscle soreness or muscle ache

nausea nosebleeds or bleeding gums peeling of skin on palms of hands or soles of feet racing heart rate skin rash or darkening stomach upset or irritation swelling trouble sleeping unusual tiredness weight loss

Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood donation: People who take isotretinoin should not give blood during treatment and for one month after stopping treatment in case the blood is given to a pregnant woman.

Depression: People with mood disorders or depression should take caution while using this medication. If you experience any symptoms of sadness, hopelessness, trouble sleeping, or lack of appetite, or if you have suicidal thoughts, stop taking this medication and contact your doctor immediately.

Medical conditions: This medication can worsen certain medical conditions and symptoms. Take this medication with caution and consult your doctor if you have any of the following medical conditions:

• asthma
• depression or mood disorders
• diabetes
• heart disease
• high cholesterol
• inflammatory bowel disease
• kidney disease
• liver disease
• osteoporosis

Night vision: Decreased night vision has been reported during isotretinoin therapy. Because some patients experienced sudden onset, use caution when driving or operating any vehicle at night. Report any vision changes to your doctor.

Pregnancy: There is an extremely high risk of major birth defects if pregnancy occurs during treatment with isotretinoin or up to one month following its discontinuation.

Women who may become pregnant must not be given isotretinoin until pregnancy is excluded. A pregnancy test must be performed within 2 weeks prior to starting treatment. Isotretinoin treatment should start on the second or third day of the next normal menstrual period following this negative pregnancy test. Effective birth control must be used for at least one month before starting isotretinoin treatment, during the treatment, and for at least 1 month following the discontinuation of treatment. It is recommended that 2 reliable forms of birth control be used at the same time unless abstinence is the chosen method.

It is strongly recommended that all women who may become pregnant and who also take isotretinoin have regular monthly pregnancy tests during the treatment and 1 month after the discontinuation of treatment.

Breast-feeding: It is not known if isotretinoin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between isotretinoin and any of the following:

• acitretin
• corticosteroids
• phenytoin
• progestin-only birth control pills
• St. John's wort
• tetracyclines
• vitamin A

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.