Concerta Side Effects

Concerta side effects range in severity and include headache, dry mouth and seizures.

As of June 2024, the most frequently reported adverse event in the Food and Drug Administration’s Adverse Event Reporting System is that Concerta was ineffective. This accounted for 10.42% of all reports the FDA received.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

FAERS data represents rare cases and does not indicate the average response in most patients. While there is a low percentage of adverse reactions in the total population taking Concerta, patients should always discuss their full medical history with their doctor before starting the medication and report any new or worsening side effects when on it.

Decreased appetite, headache and dry mouth are the most common Concerta side effects reported in prescribing information.

Most patients taking Concerta don’t experience any adverse reactions, and those who do usually report mild to moderate symptoms. The type and frequency of side effects also differed between adults and children in clinical trials.

Side effects typically last for a few days to a few weeks. Patients should speak to their doctor about any symptoms that do not clear up on their own or worsen over time.

Serious Concerta side effects include heart problems, seizures, psychiatric issues and allergic reactions.

Concerta use is linked to Raynaud’s phenomenon, a disorder characterized by a loss of blood flow to the fingers and toes, causing them to turn pale and eventually blue. This condition occurs when small blood vessels in the fingers or toes spasm, temporarily cutting off blood flow and causing pain and discoloration.

Some patients report prolonged erections (priapism) while taking methylphenidate-containing medications like Concerta. This condition occurs when blood becomes trapped in the penis. It typically develops after prolonged Concerta use or dosage increases. Priapism is rare, but anyone who experiences it should get immediate medical attention.

Cardiovascular Effects

Concerta may cause an increase in blood pressure or heart rate.

However, in November 2011, the FDA released a safety update referencing a study that showed no evidence of ADHD medications, such as Concerta, causing an increased risk for adverse cardiovascular reactions.

Despite this, the organization still recommends doctors to monitor patients who take ADHD medications for any changes in heart rate or blood pressure. The FDA also stated that those who have preexisting heart conditions should generally not take stimulants such as Concerta.

A 2022 review published in Frontiers in Neuroscience echoes this advice. The study found that ADHD medications are typically safe but advised caution in prescribing these drugs to anyone with an established history of cardiovascular disease.

In the article’s conclusion, the authors wrote “Review of published evidence shows that stimulant and non-stimulant ADHD medications have generally good cardiovascular safety profiles but given their mechanisms of action, they should be used cautiously in children and adults with pro-arrhythmic cardiovascular diseases.”

It’s important to monitor the patient’s heart health for the duration of the medication course. Anyone who experiences chest pain or signs of cardiac issues while taking Concerta should get immediate medical treatment. Anyone with a serious cardiac disease, high blood pressure or a fast heart rate has an increased risk of complications.

Involuntary Movements

Concerta prescribing information contains multiple warnings about the potential for developing involuntary movements or tics.

However, a review of prior study results that was published in the Journal of the American Academy of Child & Adolescent Psychiatry in 2015 showed no statistical correlation between ADHD medications and the development of tics.

The reason for the high occurrence of tics in patients taking Concerta may be due to the strong correlation between ADHD and tics, regardless of medication. Regardless, patients should follow the advice on the drug label. Children who have Tourettes’s Syndrome or already experience tics should not take Concerta.

Stunted Growth

Based on a 2010 study in European Child & Adolescent Psychiatry, children who regularly use psychostimulants like Concerta might have a slightly slower growth rate. Over three years, the children on Concerta grew about 1 centimeter less per year compared to their peers. During that time, weight was affected too, as the children on Concerta gained about 6-7 fewer pounds than their peers.

Most of the child participants resumed normal growth after stopping the drug.

A 2021 review and meta-analysis published in Neuroscience and Biobehavioral Reviews also showed a connection between the use of Concerta’s active ingredient methylphenidate and reduced growth rates in prepubescent children. However, it noted that the effects were minimal and appeared to have little or no clinical significance.

Drug and Condition Interactions

Concerta interacts with several other drugs, including vasopressor agents that increase blood pressure, anticoagulant blood thinners, halogenated anesthetics that are typically used for surgery and certain antidepressants such as monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitors (SSRIs).

Concerta may exacerbate conditions such as anxiety, agitation and motor tics. Because Concerta increases eye pressure, doctors generally do not prescribe it to patients with glaucoma. Anyone with a seizure disorder should be cautious when using Concerta because the drug may increase the risk of convulsions. Patients who take medication from the antidepressant class MAOI should avoid Concerta as it can cause a dangerous rise in blood pressure.

Patients taking Concerta may experience psychiatric side effects like mania or symptoms of psychosis like hallucinations and delusions, especially if they are predisposed to such symptoms. Others may display aggressive behavior. These symptoms are rare.

Some younger patients may have an increased risk of suicidal thoughts or attempts while taking methylphenidate, but others find ADHD medications like Concerta to be helpful in treating suicidal ideation.

A large 2017 study published in JAMA Psychiatry found that the risk of suicide in patients on methylphenidate was most common in patients who were already suicidal before treatment. High levels of suicidal ideation remained during the first 90 days of treatment but dropped by 72% with continued treatment. This study indicates that an increased risk of suicide is not related to methylphenidate-containing drugs.

However, a more recent 2022 study published in the Journal of BMJ found that, when controlled for factors such as depression or alcoholism, suicidal ideation increased in some patients on methylphenidate. This increase was especially prevalent in women and patients aged 40 or older.

Because evidence linking Concerta to suicidality is mixed, anyone on the medication who experiences new or worsening symptoms of depression or thoughts of suicide should inform their doctor as soon as possible.

The FDA requires that Concerta carry a boxed warning concerning the drug’s high potential for abuse, addiction or misuse in patients. These behaviors can lead to a substance use disorder and carry the risk of overdose or death.

Concerta is a Schedule II controlled substance, meaning it has a high potential for dependence and abuse. It can create an amphetamine-like high when crushed and snorted or lead to psychotic episodes if taken intravenously. The label cautions doctors when prescribing Concerta to anyone with a history of drug or alcohol use.

Misuse of stimulants designed for ADHD treatment is alarmingly common, with many people taking it for weight loss or to improve their academic performance. The Journal of Medical Research published a 2020 internet review of tweets about the drug, showing that 5.19% were about nonmedical use.

Furthermore, a 2020 review of stimulant use among college students in the Journal of American College Health revealed that, in seven colleges across Georgia, 45.7% of all students who were taking prescription stimulants did not have a prescription or ADHD diagnosis.

Patients who abuse Concerta can develop serious withdrawal symptoms such as depression, fatigue, agitation, drowsiness or slowed movements. The increased risk of dependence means that patients should only take Concerta as prescribed by their doctor.

Parents of children taking Concerta should be keenly aware of the prescription instructions and monitor their child for any signs of misuse.

Editor Lindsay Donaldson contributed to this article.