Mydayis Risks, Warnings, and Complications

POTENTIAL FOR ABUSE AND ADDICTION: Mydayis and other ADHD medications (stimulants) are federally controlled substances (Schedule II drugs) with a high potential for abuse and misuse. These prescription medicines can be habit-forming. Taking Mydayis other than exactly as prescribed can lead to physical and psychological dependence and addiction. In addition, misuse and abuse of CNS stimulants such as Mydayis is associated with a high risk of possibly fatal overdose.

Before starting Mydayis treatment for ADHD, tell your doctor if you have a personal or family history of drug abuse (misuse or abuse of alcohol, street drugs, or prescription drugs). 

 Do not take a bigger dose or take Mydayis more frequently than prescribed. Do not give or sell your Mydayis to others - this is illegal. Store Mydayis capsules in a safe place to prevent others from stealing them or ingesting them accidentally. Never obtain Mydayis from illegal sources. Do not use the drug in unapproved ways, such as snorting or injecting it. 

RISK IN PATIENTS WITH SEVERE HEART DISEASE: There are reports of sudden death in people with severe heart disease, such as structural heart abnormalities, cardiomyopathy, coronary artery disease, heart arrhythmias, and other serious cardiovascular diseases, while on treatment with CNS stimulants such as Mydayis for ADHD.

 Tell your doctor if you have a history of heart problems before starting treatment for ADHD with stimulants. Seek emergency medical attention for symptoms such as chest pain, chest pressure, or difficulty breathing while on this drug.

INCREASED BLOOD PRESSURE AND HEART RATE: Stimulant medications, including Mydayis, can increase blood pressure and heart rate. Your doctor will monitor your blood pressure and heart rate while you are on this medication. Talk to your doctor about adjusting the dose of your blood pressure medicine if you take one.

ADVERSE PSYCHIATRIC REACTIONS: Mydayis and other CNS stimulants can cause worsening mental symptoms in people with psychotic disorders. These medications can also cause or worsen bipolar illness and trigger manic episodes or mixed episodes in people with bipolar disorder.

 Some people receiving Mydayis develop new psychotic symptoms (changes in thinking and behavior), manic symptoms (abnormal excitement or frenzy), delusions, paranoia, or hallucinations. Tell your doctor immediately if you notice any unusual mood changes or behavior problems. You may need to interrupt treatment with Mydayis if you develop adverse psychiatric effects.

 Before starting Mydayis therapy, tell your doctor if you have a personal or family history of depression, bipolar disorder, psychosis, or suicide attempts, or if you take psychiatric medications.

LONG-TERM SUPPRESSION OF GROWTH IN CHILDREN: Mydayis and other prescription stimulant medicines can cause weight loss and slowed growth in pediatric patients. Your child’s healthcare provider will monitor their growth (height and weight) carefully during treatment with Mydayis. Your child may need to stop taking the ADHD medication if they are not growing and gaining weight at the expected rate for their age.

SEIZURES: CNS stimulants such as Mydayis can lower the seizure threshold in people with a history of epilepsy (seizure disorders) or abnormal brain wave test (EEG). Rarely, convulsions (seizures) can occur in people with no previous history of seizures or EEG abnormalities. You will need to discontinue Mydayis if you experience seizures.

SEROTONIN SYNDROME: People receiving Mydayis can develop potentially life-threatening serotonin syndrome, a condition that occurs due to too much serotonin, which is a natural chemical in the brain. Risk factors include the use of other serotonergic drugs that also increase serotonin levels, such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), triptans for migraine headaches, opioid drugs like fentanyl and tramadol, mood stabilizers like lithium, anti-anxiety drugs like buspirone, and dietary supplements like tryptophan and St. John's Wort.

 Give your doctor a complete list of your medications before starting treatment with Mydayis. Stop taking Mydayis and seek emergency medical care at the nearest emergency room if you develop signs and symptoms of serotonin syndrome, such as mental status changes (agitation, confusion, delirium, hallucinations, or loss of consciousness), fast heartbeat, changes in blood pressure, dizziness, sweating, flushing, fever, tremors, muscle rigidity, muscle twitching, incoordination, convulsions, nausea, vomiting, or diarrhea. 

PERIPHERAL VASCULAR DISEASE: Mydayis and other CNS stimulants can cause peripheral vasculopathy (circulation problems), including Raynaud's phenomenon. Call your doctor immediately if you develop symptoms of blood flow problems, such as changes in your fingers and toes, including color changes (pale or blue), temperature sensitivity, burning, numbness, tingling, or unexplained wounds. These symptoms usually go away after the dose is reduced or treatment is stopped.

TICS: Mydayis and other CNS stimulants can cause motor and verbal tics and worsening symptoms of Tourette's syndrome. Tell your healthcare provider if there is a personal or family history of tics or Tourette's syndrome before starting Mydayis.