What You Should Know About Dyanavel XR Side Effects

Every medication comes with potential side effects, and Dyanavel XR is no exception. Whether you're just starting treatment or considering Dyanavel XR for your child, knowing what to expect can help you feel more prepared — and help you recognize when something needs medical attention.

This guide covers the most common and serious side effects of Dyanavel XR based on FDA labeling, plus practical tips for managing them.

What Is Dyanavel XR?

Dyanavel XR is a brand-name prescription medication containing Amphetamine, a CNS stimulant. It's FDA-approved to treat ADHD in patients aged 6 and older and is available as an extended-release oral suspension (liquid) and extended-release tablets. It's manufactured by Tris Pharma and is classified as a Schedule II controlled substance.

Common Side Effects of Dyanavel XR

The following side effects are reported most frequently in clinical trials. They're usually mild to moderate and may improve as your body adjusts to the medication:

• Decreased appetite — This is the most commonly reported side effect. Many patients, especially children, notice a significant reduction in hunger.
• Insomnia — Difficulty falling or staying asleep is common with stimulant medications, especially if taken later in the day.
• Abdominal pain — Stomach discomfort, cramping, or pain may occur, particularly in the first few weeks.
• Nausea — Some patients feel queasy, especially when first starting the medication.
• Weight loss — Closely related to decreased appetite, unintended weight loss can occur over time.
• Dry mouth — A common side effect of stimulants that can usually be managed by staying hydrated.
• Emotional lability — Mood swings, irritability, or emotional sensitivity may occur, particularly in children.
• Dizziness — Some patients feel lightheaded, especially when standing up quickly.
• Restlessness — A feeling of being jittery or unable to sit still.
• Tachycardia — A faster-than-normal heart rate is possible with stimulant medications.
• Epistaxis (nosebleeds) — Reported in some patients taking Dyanavel XR.
• Allergic rhinitis — Nasal congestion or runny nose has been reported in clinical trials.

Most of these side effects are temporary and tend to lessen within the first few weeks of treatment. If they persist or become bothersome, talk to your doctor — a dosage adjustment may help.

Serious Side Effects and Warnings

While less common, Dyanavel XR carries several important warnings that you should be aware of:

Boxed Warning: Abuse, Misuse, and Addiction

Dyanavel XR has a boxed warning (the FDA's most serious warning) about the potential for abuse, misuse, and addiction. As a Schedule II controlled substance, Amphetamine has a high potential for abuse. Your doctor should assess your risk before prescribing and monitor you throughout treatment.

Cardiovascular Risks

• Sudden cardiac death has been reported in patients with pre-existing structural heart abnormalities or other serious cardiac conditions.
• Stroke and heart attack (myocardial infarction) have occurred in adults taking stimulant medications.
• Hypertension — Dyanavel XR can raise blood pressure. Your doctor should monitor your blood pressure regularly.

Before starting Dyanavel XR, tell your doctor if you have any history of heart problems, including structural heart defects, cardiomyopathy, serious arrhythmias, or coronary artery disease.

Psychiatric Effects

• New or worsening psychotic or manic symptoms — including hallucinations, delusional thinking, or mania — can occur, even in patients without a prior history of psychiatric illness.
• Serotonin syndrome — A potentially life-threatening condition that can occur when Dyanavel XR is combined with serotonergic drugs such as SSRIs, SNRIs, or Triptans.

Other Serious Side Effects

• Peripheral vasculopathy including Raynaud's phenomenon — Look for unexplained wounds on fingers or toes, skin color changes, or sensitivity to temperature.
• Seizures — Stimulants may lower the seizure threshold. If you have a seizure disorder, discuss the risks with your doctor.
• Growth suppression in children — Long-term use of stimulants may slow growth in children. Your doctor should monitor height and weight regularly.

Side Effects in Specific Populations

Children Under 6

Dyanavel XR is not recommended for children under 6 years old. Studies showed higher plasma exposure and a higher incidence of side effects — particularly weight loss — in younger children.

Pregnancy

Dyanavel XR may cause withdrawal symptoms in newborns. If you're pregnant or planning to become pregnant, discuss the risks and benefits with your doctor.

Breastfeeding

Amphetamine passes into breast milk. Breastfeeding while taking Dyanavel XR is not recommended.

How to Manage Common Side Effects

Here are some practical strategies for dealing with the most common side effects:

• Decreased appetite and weight loss: Eat a good breakfast before the medication kicks in. Offer nutrient-dense snacks in the evening when the medication wears off. Track weight regularly.
• Insomnia: Take Dyanavel XR in the morning — never in the afternoon or evening. Establish a consistent bedtime routine. Avoid caffeine.
• Dry mouth: Drink plenty of water throughout the day. Chew sugar-free gum or suck on sugar-free candies.
• Stomach pain or nausea: Take the medication with food if your doctor approves. These symptoms often improve after the first week or two.
• Emotional lability: If mood swings are significant, talk to your doctor. A dose adjustment or medication change may help.
• Dizziness: Stand up slowly from sitting or lying positions. Stay hydrated.

When to Call Your Doctor

Contact your doctor right away if you experience:

• Chest pain, shortness of breath, or fainting
• New or worsening psychiatric symptoms (hallucinations, paranoia, extreme mood changes)
• Signs of circulation problems (unexplained wounds, color changes, or cold/numb fingers or toes)
• Seizures
• Signs of serotonin syndrome (agitation, confusion, rapid heart rate, high fever, muscle stiffness)
• Significant weight loss or failure to grow (in children)

Call 911 or go to the nearest emergency room for any symptoms that feel life-threatening.

Final Thoughts

Most people who take Dyanavel XR experience only mild side effects that improve over time. The key is to stay in close communication with your doctor, report any changes you notice, and never adjust your dose on your own. If you're having trouble finding Dyanavel XR at your pharmacy, Medfinder can help you locate a pharmacy with it in stock.