"Physiological effects of oral cocaine and methylphenidate were similar."

ABOVE: Rush, C.R., et al. "Behavioral pharmacological similarities between methylphenidate and cocaine in cocaine abusers," Exp. Clin. Psychopharmacol: Feb;9(1):59-73(2001): www.ncbi.nlm.nih.gov/pubmed/11519636.

Many think methylphenidate is safe, or mild, because so many children use it. However, the government classifies the psychoactive drug with cocaine and morphine because it is highly addictive.

Methylphenidate Side Effects and Warnings

Updated November 16, 2018

Schedule II Substance

Brand Names: CONCERTA, DAYTRANA, FOCALIN, FOCALIN XR, METADATE CD, METADATE ER, QUILLIVANT XR, RITALIN, RITALIN LA, RITALIN SR
Generic Names: methylphenidate hydrochloride (HCI), dextro-methylphenidate (or dexmethylphenidate) hydrochloride (HCI), methylphenidate film (transdermal)
Category: CEREBRAL STIMULANTS

Methylphenidate is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.

Drug Enforcement Administration, Department Of Justice: Schedule II Controlled Substance

FDA “Black Box” Warning Label

The Food and Drug Administration (FDA) requires the following "black box" warning on all methylphenidate drugs, which means that medical studies indicate methylphenidate drugs carry a significant risk of serious, or even life-threatening, adverse effects.

WARNING

RITALIN-SR IS A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE IT CAN BE ABUSED OR LEAD TO DEPENDENCE. KEEP RITALIN-SR IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE. SELLING OR GIVING AWAY RITALIN-SR MAY HARM OTHERS, AND IS AGAINST THE LAW.

TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE (OR HAVE A FAMILY HISTORY OF) EVER ABUSED OR BEEN DEPENDENT ON ALCOHOL, PRESCRIPTION MEDICINES OR STREET DRUGS.

ABOVE: FDA black box warning label means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. The bold warning label appears on the manufacturer's wholesale packaging and is the strongest alert the FDA can require of drug-makers.

Used For

Attention deficit disorder
Narcolepsy

How Methylphenidate Drugs Work

We don't know exactly why it produces the effects it does. Methylphenidate was first synthesized in 1944 in an (unsuccessful) attempt to create a stimulant that would not induce addiction or tolerance. Methylphenidate drugs are very closely related to amphetamine: similar in chemical structure, metabolization and clinical effects. This close connection is the chief reason methylphenidate drug use raises concern among patients and others.

U.S. DEPT. OF JUSTICE: “Of particular concern is that ADHD literature prepared for public consumption does not address the potential or actual abuse of methylphenidate. Instead, methylphenidate is routinely portrayed as a benign, mild substance that is not associated with abuse or serious side effects. In reality, however, the scientific literature indicates that methylphenidate shares the same abuse potential as other Schedule II stimulants. Further, case reports document that methylphenidate abuse can lead to tolerance and severe psychological dependence.”

ABOVE: Drug Enforcement Administration, US Department of Justice. “Methylphenidate, A Background Paper,” NCJRS (National Criminal Justice Reference System) Abstract, NCJ 166349 (1995): www.ncjrs.gov/App/publications/abstract.aspx?ID=163349.

Do Not Use If

You have high blood pressure or any form of heart disease, are very nervous or have severe insomnia, have a history of addiction to drugs or alcohol. Do not combine with monoamine oxidase inhibitors.

Common Side Effects

Addiction
Nervousness including agitation, anxiety and irritability
Trouble sleeping (insomnia)
Decreased appetite
Headache
Stomach ache
Nausea
Dizziness
Heart palpitations

Other Serious Side Effects Include

slowing of growth (height and weight) in children
seizures, mainly in patients with a history of seizures
eyesight changes or blurred vision

Less Common Side Effects

High blood pressure
Rapid pulse rate (and other heart problems)
Tolerance (constant need to raise the dose)
Feelings of suspicion and paranoia
Visual hallucinations (seeing things that are not there)
Depression
Cocaine craving
Dermatoses (infected or diseased skin)
Urinary tract infection
Infection or viral infection
Elevated ALT enzyme levels in the blood (signaling liver damage)

FDA Warning: Links Between ADHD Drugs and Priapism and Sexual Dysfunction

In a recent drug-safety announcement, the FDA announced that drugs containing methylphenidate must including warnings about the risk of priapism. (Methylphenidate drugs include: Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant, and Ritalin.) It's a serious problem: priapism is a persistent, usually painful, erection that lasts for more than four hours and occurs without sexual stimulation. If the condition is not treated immediately, it can lead to scarring and permanent erectile dysfunction.

The FDA included an even stronger warning about atomoxetine (Strattera): “Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate products. Health care professionals should be cautious when considering changing patients from methylphenidate to atomoxetine.”

The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse.

ABOVE: U.S. FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes. (12/17/2013).

Overdose Side Effects

Methylphenidate drugs have been extensively abused. Extreme psychological dependence and severe social disability have resulted. Abuse of methylphenidate drugs may cause a sudden heart attack even in those with no signs of heart disease. Symptoms of overdose that require immediate medical assistance include:

Restlessness
Tremor
Aggression
Hallucinations
Panic states
Hyperreflexia (overactive reflexes, which can include twitching or spasms)
Personality changes
Symptoms of depression
Seizures or abnormal EEGs
High blood pressure
Rapid heart beat
Swelling of hands/feet/ankles (for example, numbing of the fingertips)
Delusions
Sweating
Vomiting
Dehydration
Unexplained muscle pain
Lower abdominal pain
Rhabdomyolysis and kidney damage
Chronic abuse can manifest itself as psychosis, often indistinguishable from schizophrenia

What to Do About Side Effects

The last dose of the drug every day should be taken several hours before bedtime to prevent insomnia.

Nervousness usually goes away and appetite often returns so that weight loss is rarely dangerous.

If high blood pressure, rapid pulse, paranoia, or tolerance becomes a problem, the drug is usually stopped.

Nothing can be done about the addiction except to remember not to stop taking any version of methylphenidate abruptly.

The use of clonidine and methylphenidate in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA.

ABOVE: Cantwell D.P., Swanson J., Connor D.F. “Case study: adverse response to clonidine.” J Am Acad Child Adolesc Psychiatry 1997;36:539-44.

Methylphenidate drugs are Schedule II Substances, which means methylphenidate drugs have a "high potential for abuse" that "may lead to severe psychological or physical dependence," and the federal government sets limits on the amount of methylphenidate drugs that may be manufactured each year.

ABOVE: 21 USC Sec. 812 01/22/02. Drug Enforcement Administration, US Department of Justice. www.dea.gov/pubs/csa/812.htm.

Dependence, Tolerance and Withdrawal

It is possible to build up a tolerance to methylphenidate drugs, which means the person using the drug needs to take larger doses to achieve the same effect. Over time, the body might come to depend on methylphenidate drugs just to function normally. The person craves the drug and their psychological dependence makes them panic if access is denied, even temporarily.

Withdrawal symptoms can include tiredness, panic attacks, crankiness, extreme hunger, depression and nightmares. Some people experience a pattern of "binge crash" characterized by using continuously for several days without sleep, followed by a period of heavy sleeping.

If It Doesn't Work

The drug should be stopped gradually. Withdrawal symptoms are psychological and stopping suddenly can cause extreme fatigue and severe, even suicidal, depression in adult patients.

Abrupt cessation of stimulant drugs such as methylphenidate drugs can cause extreme fatigue and severe, even suicidal, depression in adult patients.

ABOVE: The Essential Guide to Psychiatric Drugs—Rev. and updated (2007).

If It Does Work

"Also, in addition to increasing heart rate and blood pressure, causing insomnia and weight loss, and sometimes causing psychotic symptoms, the stimulant medications used for ADHD (methylphenidate drugs and amphetamines) may cause heart disease if taken for a long time. The latter problem led to a debate within the FDA, well covered by newspapers, about whether to issue a special warning to doctors. In the end, the FDA decided not to do this, but the risk remains," reports Jack M. Gorman, M.D., professor of psychiatry at Columbia University and deputy director of the New York State Psychiatric Institute.

A review of 20-years of scientific literature on using stimulant medications, including methylphenidate drugs, to treat children with ADD and ADHD found a consensus: there is no documented long-term benefit (academic achievement or pro-social behavior) in using psychoactive drugs.

ABOVE: Swanson, J.M., et al. "Effect of stimulant medication on children with attention deficit disorder: a review of reviews," Exceptional Children, 60:154-62, 1993.

Ritalin [Methylphenidate]:
The People's Pharmacy

(1976:) Some health professionals fear that these medications may end up being over prescribed. Dr. Carl Kline, an expert in the field of learning disabilities from the University of British Columbia, had this to say:

It is my belief that if these drugs were outlawed, children would not be at all deprived of essential medication, but that doctors would be forced to make more accurate diagnoses and seek better means of handling the hyperactive behavior of a certain small percentage of their little patients.

Do these drugs make a difference in the long-term outcome?

Until recently, the most important question concerning Ritalin or amphetamine administration has not been asked. Do these drugs make a difference in the long-term outcome? A comprehensive examination of this subject carried out at the Montreal Children's Hospital discovered a startling fact. At the end of five years, hyperactive children who received Ritalin did not differ significantly from children who had not received. Although it appeared that hyperactive kids treated with Ritalin were initially more manageable, the degree of improvement and emotional adjustment was essentially identical at the end of five years to that seen in a group of kids who had received no medication at all.

Parents might want to consider another approach.

Emergency room visits by children ages 10-14 involving methylphenidate intoxication or overdoses have now reached the same level as those for cocaine--indicating escalating abuse of the addictive drug.

ABOVE: Diller, L.H. Running on Ritalin: A Physician Reflects on Children, Society, and Performance in a Pill; Bantam Doubleday Dell Pub. Group, Inc. (1998); citing Feussner, G. "Actual Abuse Issues," Conference Report: Stimulant Use in the Treatment of ADHD, Drug Enforcement Administration, US Department of Justice, Washington DC, Dec. 1996.

SOURCES:
Ritalin-SR Medication Guide, rev. 4/2007: www.fda.gov/downloads/Drugs/DrugSafety/ucm089095.pdf
National Institute of Mental Health. Medications. Bethesda, MD: National Institute of Mental Health, National Institutes of Health, US Department of Health and Human Services; NIH Publication No. 02-3929, 2007 ed.: www.nimh.nih.gov/health/publications/medications/medications.pdf.
Physicians' Desk Reference, 58th ed. Montvale, NJ: Thomson PDR, 2004.
Johns Hopkins Medicine, Health Alerts, "Heart Attack: Symptoms and Remedies": www.johnshopkinshealthalerts.com/symptoms_remedies/heart_attack/83-1.html#3 (2008).
Sadock, B.J., et al. Kaplan and Sadock's Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry (Synopsis of Psychiatry), 10th ed. Philadelphia, PA; Lippincott Williams & Wilkins, 2007.
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC, 2000, as cited above.
Gorman, Jack M. The Essential Guide to Psychiatric Drugs—Rev. and updated, 4th ed. New York, NY: St. Martin's Press, 2007.
Cohen, J.S. Over Dose: The Case Against the Drug Companies: Prescription Drugs, Side Effects, and Your Health. New York: Penguin Putnam Inc., 2001.
Graedon, J. The People's Pharmacy. New York: Avon Books and St. Martin's Press, Inc., 1976.
Drummond, E.H. The Complete Guide to Psychiatric Drugs: Straight Talk for Best Results, Rev. and expanded. New Jersey: John Wiley & Sons Inc., 2006.
Reichenberg-Ullman, J., et al. Ritalin Free Kids; California: Prima Health, Prima Publishing (1996).
Graedon, J. The People's Pharmacy. New York: Avon Books and St. Martin's Press, Inc., 1976.
Diller, L.H. Running on Ritalin: A Physician Reflects on Children, Society, and Performance in a Pill; Bantam Doubleday Dell Pub. Group, Inc. (1998).
Health Canada, Canadian Adverse Reaction Newsletter, Vol. 16, No. 3, Jul 2006: www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v16n3-eng.php#a3.

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Methylphenidate Drug Names

BRAND NAME	GENERIC NAME
Concerta	methylphenidate hydrochloride (HCI) [extended release]
Daytrana	methylphenidate film, transdermal [extended release]
Focalin	dextro-methylphenidate (or, dexmethylphenidate) hydrochloride (HCI) [instant release]
Focalin XR	dextro-methylphenidate hydrochloride (HCI) or dexmethylphenidate hydrochloride (HCI) [extended release]
Metadate CD	methylphenidate hydrochloride (HCI) [extended release: ONE-a-day]
Metadate ER	methylphenidate hydrochloride (HCI) [extended release: TWO- or THREE-a-day]
Methylin	methylphenidate hydrochloride [instant release]
Methylin ER	methylphenidate hydrochloride [extended release]
Quillivant XR	methylphenidate hydrochloride [extended release; liquid]
Ritalin	methylphenidate hydrochloride (HCI) [instant release]
Ritalin LA	methylphenidate hydrochloride (HCI) [extended release: one-a-day, rapid onset with two peak levels]
Ritalin SR	methylphenidate hydrochloride (HCI) [extended release: one-a-day, slower onset with more continuous delivery]
Attenta†	methylphenidate hydrochloride (HCI) [instant release]; AU
Biphentin†	methylphenidate hydrochloride (HCI) [extended release]; CA
Equasym†	methylphenidate hydrochloride (HCI) [instant release]; EU
Equasym XL†	methylphenidate hydrochloride (HCI) [extended release]; EU
Motiron†	methylphenidate hydrochloride (HCI) [instant release]; EU
Rubifen†	methylphenidate hydrochloride (HCI) [instant release]; NZ

†Not sold in U.S.

NY Times: Children's A.D.D. Drugs Don't Work Long-Term

The NY Times, in an op-ed article by L. Alan Sroufe, a professor emeritus of psychology at the University of Minnesota's Institute of Child Development:

“Attention-deficit drugs increase concentration in the short term, which is why they work so well for college students cramming for exams. But when given to children over long periods of time, they neither improve school achievement nor reduce behavior problems. The drugs can also have serious side effects...

“Many parents who take their children off the drugs find that behavior worsens, which most likely confirms their belief that the drugs work. But the behavior worsens because the children's bodies have become adapted [because the drugs are habit-forming] to the drug. Adults may have similar reactions if they suddenly cut back on coffee, or stop smoking.”

ABOVE: L. Alan Sroufe, “Ritalin Gone Wrong: Children's A.D.D. Drugs Don't Work Long-Term,” New York Times, pg SR1, NY ed, 1/28/2012.

Long-Term Effects of Methylphenidate:
Changes in Brain Development

Ongoing research shows early-life use of methylphenidate has complex effects that endure later into life. A study published in Biological Psychiatry suggests that exposure of methylphenidate in youth may later disrupt development of brain cells in the hippocampus, region of the brain critical to memory, spatial navigation, and behavioral inhibition. Damage can lead to memory problems, disorientation and depression in adulthood.

In Alzheimer's disease, the hippocampus is one of the first areas of the brain to suffer damage; memory problems and disorientation appear among the first symptoms.

ABOVE: Lagace, D.C., et al. “Juvenile administration of methylphenidate attenuates adult hippocampal neurogenesis.” Biol Psychiatry 60:1121-1130, 2006. Wang L., et al. “Changes in hippocampal volume and shape across time distinguish dementia of the Alzheimer type from healthy aging.” NeuroImage vol. 19, 2003. Zhao Z. et al. “Hippocampus shape analysis and late-life depression.” Plos One 3(3): e1837, 2003.

The question of whether methylphenidate drugs impair creativity in children

Methylphenidate drugs may have subtle impacts on cognitive and intellectual processes. Both parents and researchers have noticed that children taking methylphenidate drugs sometimes answer questions in ways that seem overly compliant or narrow, suggesting the drug might restrict creative thinking. One study found hyperactive children taking methylphenidate offered less varied answers to open-ended questions.

How much do the "neuro-enhancing" drugs really help?

And there's the question of what we mean by "smarter."

The psycho-stimulants help students bear down on their work, but with odd effects. One college student says he spends "too much time researching a paper rather than actually writing it--a problem, I assure you, that is common to all intellectually curious students on stimulants." Another student looked back at papers he'd written while on Adderall and found them verbose, "I'd produce two pages on something that could be said in a couple of sentences."

Could enhancing one kind of thinking exact a toll on others?

All these questions need proper scientific answers, but for now much of the discussion is taking place furtively, among an increasing number of Americans who are performing daily experiments on their own brains (or their children's brains).

SOURCES: Diller, L.H. Running on Ritalin: A Physician Reflects on Children, Society, and Performance in a Pill; Bantam Doubleday Dell Pub. Group, Inc. (1998); citing Feidler, N.L., et al., "The effects of stimulant drugs on curiosity behaviors of hyperactive boys," Journal of Abnormal Child Psychology, 11:193-206 (1983). Talbot, M. "Brain Gain: The underground world of 'neuroenhancing' drugs," The New Yorker, 4/2009.

"It's Not the Real You. It's a Fake Person"

Not all children with ADD feel better on methylphenidate drugs. One teenager said: "It's not the real you. It's a fake person." Another, after being on methylphenidate drugs for seven years, begged his parents not to make him take it, but one of his teachers would not allow him into her classroom unless he had a note signed by the school nurse that he had received Ritalin at school that day. The boys complained of dizziness, stomach upset, inability to sleep, a buzzed feeling, and appetite-loss because of Ritalin.

ABOVE: Reichenberg-Ullman, J., et al. Ritalin Free Kids; California: Prima Health, Prima Publishing (1996).

Use of Clonidine with Methylphenidate is Controversial

The use of clonidine and methylphenidate in combination continues to be controversial. Both drugs can adversely affect an irregular heart rate or rhythm (cardiac arrhythmia) and this effect can be worsened when the drugs are combined. Four deaths of children using both drugs were reported to the FDA. [More]

Adderall XR Side Effects

In small doses amphetamines can banish tiredness and make the user feel alert and refreshed. However, the burst of energy comes at a price. A "speed crash" always follows the high and may leave the person feeling nauseous, irritable, depressed and extremely exhausted. [More]

Vyvanse is a “Pro-Drug”

Although Vyvanse is referred to as “pro-drug” of dextroamphetamine, it is still an amphetamine, meaning that Vyvanse is easily abused and can cause insomnia, agitation, anxiety and sometimes psychotic symptoms like seeing things or becoming paranoid. [More]

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