According to most estimates, more than 75 percent of Ritalin prescriptions are for children. Boys are about four times as likely to take Ritalin as girls.
Ritalin Side Effects and Warnings
- Brand Names: RITALIN, RITALIN LA, RITALIN SR
- Generic Name: METHYLPHENIDATE HCI (HYDROCHLORIDE)
- Category: CEREBRAL STIMULANTS
Ritalin (methylphenidate) is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.
Many think Ritalin (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.
Were you fully aware of all the "warnings," "drug dependency risks," "precautions," and "adverse reactions" related to the use of RITALIN?
FDA “Black Box” Warning Label
The Food and Drug Administration (FDA) requires the following "black box" warning on all methylphenidate drugs, including Ritalin, which means that medical studies indicate Ritalin carries a significant risk of serious, or even life-threatening, adverse effects.
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.
- Attention deficit disorder
How Ritalin Works
We don't know exactly why it produces the effects it does. Methylphenidate (Ritalin) was first synthesized in 1944 in an (unsuccessful) attempt to create a stimulant that would not induce addiction or tolerance. Ritalin is very closely related to amphetamine: similar in chemical structure, metabolization and clinical effects. This close connection is the chief reason Ritalin use raises concern among patients and others.
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
- Nervousness including agitation, anxiety and irritability
- Trouble sleeping (insomnia)
- Decreased appetite
- Stomach ache
- 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)
- 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:
- 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)
- 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.
Ritalin is a Schedule II Substance, which means Ritalin has a "high potential for abuse" that "may lead to severe psychological or physical dependence," and the federal government sets limits on the amount of these amphetamine drugs that may be manufactured each year.
Dependence, Tolerance and Withdrawal
It is possible to build up a tolerance to methylphenidate, 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 Ritalin 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 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. Ritalin “is a very powerful drug that undoubtedly works for ADHD, but there are alternatives with less abuse potential that should be tried first.”
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Ritalin Side Effects from the Physicians' Desk Reference (PDR)
Almost half of pediatricians spend less than an hour evaluating
children before prescribing Ritalin. SOURCE: Newsweek, "Ritalin: Are We Overmedicating Our Kids?" (Mar. 18, 1996).
RITALIN-SR methylphenidate hydrochloride USP sustained-release tablets.
Ritalin should not be used in children
under six years, since safety and efficacy in this age group have not
been established. Sufficient data on safety and efficacy of long-term
use of Ritalin in children are not yet available. Although a causal relationship
has not been established, suppression of growth (i.e., weight gain, and/or
height) has been reported with the long-term use of stimulants in children.
Therefore, patients requiring long-term therapy should be carefully monitored.
Nervousness and insomnia are the most common adverse reactions but
are usually controlled by reducing dosage and omitting the drug in the
afternoon or evening. Other reactions include hypersensitivity (including
skin rash, urticaria [hives], fever, arthralgia [intense burning or stabbing pain caused by irritation of or damage to a nerve], exfoliative dermatitis [peeling skin], erythema
multiforme [red blotches or blisters all over the skin] with histopathological [microscopic] findings of necrotizing vasculitis [death of blood vessels],
and thrombocytopenic purpura [purplish spots or patches]); anorexia [loss of appetite]; nausea; dizziness; palpitations [irregular, hard or rapid heartbeat];
headache; dyskinesia [muscle spasms]; drowsiness; blood pressure and pulse changes, both
up and down; tachycardia [rapid heart rate]; angina [caused by an insufficient supply of blood to the heart muscle]; cardiac arrhythmia [irregularity of the heartbeat]; abdominal pain;
weight loss during prolonged therapy. There have been rare reports of
Tourette's syndrome. Toxic psychosis has been reported. Although a definite
causal relationship has not been established, the following have been
reported in patients taking this drug: leukopenia [abnormally low number of white blood cells in the circulating blood] and/or anemia; a few
instances of scalp hair loss. In children, loss of appetite, abdominal
pain, weight loss during prolonged therapy, insomnia, and tachycardia [rapid heart rate]
may occur more frequently; however, any of the other adverse reactions
listed above may also occur.
Ritalin should be given cautiously to emotionally unstable patients, such
as those with a history of drug dependence or alcoholism, because such
patients may increase dosage on their own initiative. Chronically abusive
use can lead to marked tolerance and psychic dependence with varying degrees
of abnormal behavior. Frank psychotic episodes can occur, especially with
parental abuse. Careful supervision is required during drug withdrawal,
since severe depression as well as the effects of chronic over activity
can be unmasked. Long-term follow-up may be required because of the patient's
basic personality disturbances.
"Physiological effects of oral cocaine and methylphenidate (Ritalin) 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
Emergency room visits by children ages 10-14 involving Ritalin 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.
Ritalin Side Effects from The Essential Guide to Psychiatric Drugs
STIMULANT ANTIDEPRESSANT DRUGS
Depression may also be treated with drugs called psycho-stimulants.
Use of such drugs is reserved for only two situations: (1) patients who
have failed to respond to at least two other antidepressants and psychotherapy
and who are seriously depressed, and (2) patients with serious and usually
terminal medical illnesses such as cancer or AIDS who are depressed and
too sick to take other kinds of antidepressants.The reason for these restrictions
is that the stimulant drugs are addictive. They include amphetamines (Adderall),
sometimes called "speed" or "uppers," methylphenidate (Ritalin), and pemoline (Cylert). The
drugs produce a short-term mood elevation even in people who are not depressed.
College students take them to stay awake all night and finish term papers.In
most people the effects of these stimulant drugs are short-lived and there
is often a letdown or "crash" after they wear off. During this
"crash" the patient can feel very depressed, sleepy, and sluggish.
Furthermore, and very much unlike the other drugs discussed so far in
this chapter, stimulant drugs have the potential to induce "tolerance."
People who abuse amphetamines and other stimulants--usually in attempts
to lose weight or stay awake for prolonged periods--often find that a
dose that had worked for a while is suddenly ineffective and they need
a higher dose. They then become "tolerant" to the higher dose
and have to increase the dose again. Soon, the person is addicted to the
drug. Stopping it suddenly leads to a severe withdrawal reaction characterized
by bad depression and extreme fatigue. Suicides have been reported in
people who suddenly stop taking amphetamines. Given all these problems,
why even mention the stimulant drugs? Simply because they are the only
drugs that work for some depressed patients. A very small group of usually
chronically depressed patients seems to be resistant to every other treatment
for depression. These people usually function at a fairly low level relative
to their ability and they feel sad and blue all of the time. They complain
of fatigue, low interest in life, and inability to concentrate. Many say
they have been depressed since childhood. Another small group of patients
with very serious medical problems also develops depression. Sometimes
the medical problems they have make other antidepressant drugs unsafe,
or the medical problems so magnify the side effects of the other antidepressants
that the dying patient is made even more uncomfortable. Stimulant drugs
may actually be the safest choice in this situation. For these two groups
of patients stimulant drugs may be the only answer, even though the patient
will probably become addicted. This is not to be taken lightly. The decision
to place a patient on a stimulant drug for depression is serious and must
be done only after all other efforts are declared either unsafe or ineffective.
The patient must understand that he will probably become addicted to the
medication and that he should never stop taking it abruptly.
Ritalin: 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
Do these drugs make a difference in the long-term
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.
Street names for Ritalin include: rits, rids, west coast, jif, mph, diet coke, kiddie coke, kiddie cocaine, vitamin R, R-ball, poor man's cocaine, skippy, skittles, smarties and the smart drug.