Safety and side effects
of ONYDA™ XR

ONYDA XR can cause serious side effects, including:

Decreased blood pressure and heart rate

• ONYDA XR can decrease your blood pressure and heart rate, which can increase your chance of passing out (syncope). If you have a history of passing out or have other medical problems as mentioned above, your risk is higher
• Your healthcare provider should check your heart rate and blood pressure before starting treatment and regularly during treatment with ONYDA XR
• Do not become dehydrated or too hot (overheated) to decrease your chance of passing out during treatment with ONYDA XR

Sleepiness and tiredness that could cause slow reaction times (sedation and somnolence)

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how ONYDA XR affects you because ONYDA XR can cause sleepiness and tiredness that could cause slow reaction times
• Do not drink alcohol or take other medicines that make you sleepy or dizzy during treatment with ONYDA XR until you talk with your healthcare provider

Rebound high blood pressure (hypertension)

• Suddenly stopping ONYDA XR can cause high blood pressure to return if you have a history of high blood pressure
• Suddenly stopping ONYDA XR may also cause withdrawal symptoms including headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, tightness in your chest, and nervousness or anxiety
• Do not suddenly stop ONYDA XR treatment without first talking to your healthcare provider

Allergic reactions. You may develop an allergic reaction to ONYDA XR if you had an allergic reaction to clonidine taken through your skin in a patch. Stop taking ONYDA XR and call your healthcare provider right away or go to the nearest emergency room if you develop any signs or symptoms of an allergic reaction, including:

• skin rash
• hives
• swelling of the eyes, face, lips, or tongue

ONYDA XR should not be taken if you or your child are allergic to clonidine hydrochloride, or any of the ingredients in ONYDA XR. See the end of the Patient Information for a complete list of ingredients in ONYDA XR

Before taking ONYDA XR, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• have low or high blood pressure
• have a history of passing out (syncope)
• have heart problems, including slow heart rate or other heart rhythm problems
• had a stroke or have stroke symptoms
• had an allergic reaction after taking clonidine through your skin in a transdermal system (patch)
• are pregnant or plan to become pregnant. It is not known if ONYDA XR will harm the unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • There is a pregnancy registry for females who are exposed to ADHD medications, including ONYDA XR, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ONYDA XR and their baby. If you become pregnant during treatment with ONYDA XR, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/
• are breastfeeding or plan to breastfeed. ONYDA XR passes into the breast milk. Babies who are breastfed during treatment with ONYDA XR may become very sleepy, develop relaxed or floppy muscles, and develop trouble breathing. Call the baby’s healthcare provider if the baby is breastfed during treatment with ONYDA XR and develops any of these symptoms. Talk to your healthcare provider about the best way to feed your baby if you take ONYDA XR

ONYDA XR and certain other medicines may affect each other, causing serious side effects. Especially tell your healthcare provider if you take:

• antidepression medicines
• heart or blood pressure medicines
• other medicines for ADHD
• other medicines that contain clonidine
• medicines that cause sleepiness (sedation)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. Know the medicines that you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

If you take too much ONYDA XR, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

• The most common side effects of ONYDA XR when used alone include falling asleep or sleepiness and tiredness that could cause slow reaction times, irritability, nightmares, trouble sleeping, constipation, and dry mouth
• The most common side effects of ONYDA XR when used with other ADHD medicines include falling asleep or sleepiness and tiredness that could cause slow reaction times, decreased appetite, and dizziness
• ONYDA XR may cause fertility problems in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you
• These are not all of the possible side effects of ONYDA XR

Call your doctor for medical advice about side effects.

You may report adverse events related to Tris Pharma products by calling 1-732-940-0358 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch, where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

For more information about the possible side effects of ONYDA XR, see Full Prescribing Information.