Do not take ONYDA XR if you are allergic to clonidine.

Before taking ONYDA XR, tell your healthcare provider if you have kidney problems; low or high blood pressure; a history of passing out (syncope); heart problems (including slow heart rate or rhythm problems); had a stroke or stroke symptoms; or had an allergic reaction after taking clonidine through the skin (patch). Tell your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. It is not known if ONYDA XR may harm an unborn baby. ONYDA XR passes into breast milk and may cause sleepiness, floppy muscles, or breathing problems in breastfed babies. A pregnancy registry is available at 1-866-961-2388 or womensmentalhealth.org/adhdmedications.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ONYDA XR may interact with medicines for depression, ADHD, heart or blood pressure conditions, medicines that cause sleepiness, or other clonidine-containing medicines.

What to avoid while taking ONYDA XR?

Avoid dehydration and overheating, which may increase the risk of passing out.

Do not drive, operate machinery, or perform dangerous activities until you know how ONYDA XR affects you, because it may cause sleepiness and tiredness that can slow reaction times.

Avoid alcohol or other medicines that cause sleepiness or dizziness unless discussed with your healthcare provider.

Do not suddenly stop ONYDA XR. Stopping suddenly may cause rebound high blood pressure and withdrawal symptoms. Contact your healthcare provider before stopping treatment. If vomiting prevents you from taking ONYDA XR, contact your healthcare provider because rebound hypertension may occur.

Possible side effects

ONYDA XR may cause serious side effects including:

Low blood pressure and slow heart rate, which may increase the risk of passing out. Your healthcare provider should check your heart rate and blood pressure before and during treatment.

Sleepiness and tiredness that may slow reaction times.

Rebound high blood pressure and withdrawal symptoms after sudden stop (including headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, chest tightness, nervousness, or anxiety).

Allergic reactions. Stop taking ONYDA XR and seek medical help immediately if you develop rash, hives, or swelling of the eyes, face, lips, or tongue, especially if you previously had an allergic reaction to clonidine patch.

ONYDA XR may cause fertility problems in females and males, which may affect the ability to have a child. Talk to your healthcare provider if this is a concern.

Most common side effects when used alone:

Sleepiness/tiredness, nightmare, constipation, irritability, trouble sleeping, and dry mouth.

Most common side effects when used with other ADHD medicines:

Sleepiness/tiredness, decreased appetite, and dizziness.

These are not all possible side effects of ONYDA XR. Call your healthcare provider for medical advice about side effects. Report side effects to Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088.

Please see Full Prescribing Information and Patient Information, including Instructions for Use.