Onyda XR

Pronunciation: oh-nee-dah
Generic name: clonidine 
Dosage form: extended-release oral suspension (0.1 mg/mL)

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 31, 2024.

What is Onyda XR?

Onyda XR (clonidine) is a once-daily, non-stimulant medication for ADHD to help improve hyperactivity, impulsivity, and inattentiveness symptoms in children 6 years and older. Onyda XR is an extended-release oral liquid that is given in the evening. It can be used as a single treatment for ADHD (attention-deficit hyperactivity disorder) or together with other medications.

Onyda XR works by stimulating α-2 adrenergic receptors in the brain and is from a class of medicines called α-2 adrenergic receptor agonists. The Onyda XR (clonidine) mechanism of action (how it has its effect) on ADHD is unknown.

Onyda XR FDA approval was received on May 24, 2024, for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

Onyda XR side effects

Common Onyda XR side effects

The most common side effects of Onyda XR are tiredness, sleepiness, or falling asleep, which may cause slow reaction times, feeling irritable, trouble sleeping, nightmares, constipation, and dry mouth; these side effects occur when taken as a single ADHD therapy.

 The most common side effects of Onyda XR, when used together with other ADHD medicines, include tiredness, sleepiness, or falling asleep, which may cause slow reaction times. 

Serious Onyda XR  side effects

Get emergency medical help if you have signs of an allergic reaction to clonidine, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe chest pain, shortness of breath, irregular heartbeats;
• a very slow heart rate; or
• a light-headed feeling, like you might pass out.

Fertility side effects

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 side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Adderall, Vyvanse, methylphenidate, atomoxetine, Ritalin, Concerta

Warnings

Before you take clonidine, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to clonidine, the active ingredient in this medicine. 

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

When discontinuing Onyda XR, taper the total daily dose slowly in no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension. Do not stop taking this medicine without talking to your healthcare provider.

Before taking this medicine

You should not take this medicine if you are allergic to clonidine.

To make sure Onyda XR is safe for you, tell your doctor if you have:

• heart disease or severe coronary artery disease;
• a heart rhythm disorder, slow heartbeats;
• high or low blood pressure, or a history of fainting spells;
• a heart attack or stroke;
• pheochromocytoma (tumor of the adrenal gland);
• kidney disease; or
• if you have ever had an allergic reaction to a Catapres TTS transdermal skin patch.

Onyda XR is not approved and should no be given to a child younger than 6 years old.

Pregnancy

It is not known if Onyda XR will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant, your name may be listed on a pregnancy registry to track the effects of clonidine on the baby.

Clonidine may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or planning to breastfeed as Onyda XR passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take Onyda XR. Babies who are breastfed during treatment with this medicine 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 this medicine and develops any of these symptoms.

How should I take Onyda XR?

Onyda XR is taken 1 time daily, at bedtime, with or without food. 

Shake the bottle gently. Using an oral syringe, measure out the correct dose.

The child should be in a seated position before taking this medicine. Tilt the head slightly upwards, place the oral dosing syringe into the mouth, and point it toward the cheek. Close the mouth tightly around the syringe and slowly push the plunger all the way down to give the dose. After all the medication has been taken, remove the syringe from the mouth.

Your healthcare provider may change your dose of Onyda XR. Do not change your dose of this medicine without talking to your healthcare provider.

If you are taking another clonidine medicine, stop taking it before you start treatment with Onyda XR.  The dose of Onyda XR is not the same as other clonidine medicines. Do not change between Onyda XR and other clonidine medicines unless your healthcare provider tells you. 

Do not stop taking this medicine without talking to your healthcare provider.

Discard any unused remaining in the bottle after 60 days of first opening the bottle.

Dosing information

Initial Onyda XR dose: 0.1 mg orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals. 

Maximum recommended dosage: 0.4 mg once daily at bedtime.

Comments: Do not substitute Onyda XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles. 

When discontinuing: Taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension. 

Renal Impairment:The dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. 

Use: Patients 6 years of age and older for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications

Onyda XR (clonidine hydrochloride) 0.1 mg/mL extended-release oral suspension

What happens if I miss a dose?

If you miss a dose of this medicine, skip the missed dose and take the next dose at your regular scheduled time. Do not take more medicine in a 24-hour period than your healthcare provider prescribed for your daily dose.

What happens if I overdose?

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

What should I avoid while taking Onyda XR? 

 Avoid drinking alcohol. It may increase certain side effects of clonidine.

Avoid driving or hazardous activity until you know how clonidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

What other drugs will affect Onyda XR?

Using clonidine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• other heart or blood pressure medications;
• an antidepressant; or
• any other medicine that contains clonidine.

This list is not complete. Other drugs may interact with clonidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Storage

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from light. 
• Onyda XR expiry: Discard any unused remaining in the bottle after 60 days of first opening the bottle.

Ingredients

Active Ingredient: clonidine hydrochloride.

Inactive Ingredients: anhydrous citric acid, edetate disodium, glycerin, modified starch, methylparaben, orange flavor, polyvinyl acetate dispersion 30%, povidone, polysorbate 80, propylparaben, purified water, sucrose, sodium polystyrene sulfonate, triacetin, and xanthan gum

Company

Manufactured by/Distributed by: Tris Pharma, Inc. Monmouth Junction, NJ 08852

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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