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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: dextroamphetamine (dex tro am FET a meen)
Brand name(s): DEXEDRINE
GENERIC: available FAMILY: Central Nervous System Stimulators
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: various amphetamines (am FET a meenz)
Brand name(s): ADDERALL, ADDERALL XR, ADZENYS, DYANAVEL XR
GENERIC: available FAMILY: Central Nervous System Stimulators
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Amphetamines caused malformations and fetal death in animal studies. Infants born to mothers dependent on amphetamines are at increased risk of premature delivery and low birth weight and may experience withdrawal symptoms. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women.

Breast-feeding Warning

Amphetamines are excreted in human milk. Because of the potential for serious adverse effects in nursing infants, you should not take amphetamines if you are nursing.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.[1]

Warning

Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities or other serious heart problems. Adderall generally should not be used in children or adults with structural cardiac abnormalities or other serious heart problems.

Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis.

Facts About This Drug [top]

Amphetamine (ADDERALL XR) and dextroamphetamine (DEXEDRINE) are approved by the Food and Drug Administration (FDA) to treat symptoms of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, a rare sleep disorder. Amphetamine and dextroamphetamine are, for all practical purposes, the same drug.

Amphetamine, like many drugs, is a mixture of chemically identical compounds that are mirror images of each other. One of the compounds that make up amphetamine is dextroamphetamine....

Amphetamine (ADDERALL XR) and dextroamphetamine (DEXEDRINE) are approved by the Food and Drug Administration (FDA) to treat symptoms of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, a rare sleep disorder. Amphetamine and dextroamphetamine are, for all practical purposes, the same drug.

Amphetamine, like many drugs, is a mixture of chemically identical compounds that are mirror images of each other. One of the compounds that make up amphetamine is dextroamphetamine. Separating these mirror images, or recombining them, and selling the combination as a “new” drug is a successful business scheme to protect patents, not a strategy to improve public health.

Amphetamine and dextroamphetamine belong to a family of central nervous system stimulant drugs sometimes called psychostimulants. Amphetamine and dextroamphetamine affect the neurotransmitters dopamine and norepinephrine.[2] Exactly how these drugs work is not fully known. Amphetamines may control the symptoms of some conditions but are not a cure for any condition.[3]

Amphetamine and dextroamphetamine are classified as Schedule II controlled substances by federal law. Misuse can result in criminal charges. All children prescribed amphetamine should be cautioned not to share or sell their medications. Each new and refill prescription requires a new, handwritten prescription. If your child is taking more than one dose a day, ask your pharmacist to divide your prescription into two labeled containers: one for home and one for school or work. Check with schools about their security procedures. Be sure that refill requests correspond to the time for the amount prescribed.

If you are subject to urine tests for employment or school, inform the appropriate parties that you take an amphetamine medication.

People with uncontrolled high blood pressure should not take any amphetamine.[4] This includes patients with mild high blood pressure.[5]

Periodically, your doctor should reassess your need to continue taking amphetamines.

Adverse effects

Psychiatric symptoms

Drugs used to treat ADHD present a slightly increased risk of drug-related psychiatric symptoms, such as hearing voices, mania or unprovoked suspiciousness, even in patients who did not have previous psychiatric problems.

In 2015, Health Canada, an agency similar to the FDA, updated the warning section of the labels of drugs used to treat ADHD on the risk of suicidal thoughts and behaviors. The advisory stated that Health Canada had received reports that included thoughts of suicide, suicide attempts and, in a very small number of cases, completed suicide. [6]

FDA black-box warning: Heart problems and other warnings

These drugs’ labels include a black-box warning informing patients about the risk of drug dependence, sudden death and serious cardiovascular problems associated with these drugs (see "FDA Black-Box Warning" at the top of this page).

However, the statement “Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events,” which appears in the black-box warning, is extremely misleading because it does not tell patients that the drugs can also cause sudden death in those using the medication properly. Sudden death has been reported in association with the use of stimulant ADHD drugs in children, adolescents and adults with structural heart abnormalities or other serious heart problems (such as heart valve disease or abnormal heart rhythm) even when these patients take the recommended doses. The FDA should immediately take steps to change the last statement in the black-box warning to say that sudden death and serious complications can occur in a wide variety of people who are not misusing the drugs.

Children, adolescents and adults who are being considered for treatment with stimulant drugs for ADHD should have a careful medical history assessment, including assessment for a family history of sudden death or heart rhythm disturbance. Patients should undergo a physical examination to assess for the presence of heart disease.[1]

FDA Medication Guide

Amphetamine and dextroamphetamine are among the limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled or refilled.

The FDA-approved Medication Guides for amphetamine and dextroamphetamine alert patients to the possible cardiovascular and psychiatric risks associated with the medicines and describe precautions that can be taken to help patients use these medications more safely.[7]

Serotonin syndrome[8]

Serotonin syndrome (excess serotonin) is a life-threatening condition that occurs when two or more drugs that have an effect on serotonin are taken together. Symptoms of serotonin syndrome include:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Fast heartbeat
  • Increased body temperature
  • Rapid changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting

Regulatory actions surrounding amphetamines

2010: The FDA updated the drug information label for amphetamines to include information on the co-administration of proton pump inhibitors and amphetamine medications. The advisory stated that patients taking this combination therapy should be monitored for changes in the clinical effect of amphetamine.[9]

2013: The FDA issued an advisory that in postmarketing reports, treatment with dextroamphetamine and mixed amphetamine is associated with peripheral vasculopathy (damage to blood vessels outside of the heart), including Raynaud’s phenomenon. These disorders typically affect the fingers and toes. Raynaud’s phenomenon is characterized by a pale to blue to red sequence of color changes of the fingers or toes, most commonly after exposure to cold. The fingers or toes also may feel numb or painful.[10]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • allergies, including to lactose, tartrazine, or aspirin
  • agitation
  • anorexia
  • arteriosclerosis
  • cardiovascular disease
  • drug abuse or dependence
  • high blood pressure
  • glaucoma
  • heart problems
  • hyperthyroidism (overactive thyroid)
  • pregnancy or are breast-feeding
  • psychosis
  • tics
  • Tourette’s syndrome

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • For narcolepsy, avoid drugs that induce sleep. Avoid other stimulants, such as caffeine, methylphenidate (RITALIN), and pseudoephedrine (SUDAFED).
  • Do not drive, operate hazardous equipment, or perform dangerous activities if you experience dizziness or euphoria, or your narcolepsy is not controlled.
  • Minimize distractions at school or work. For example, sit toward the front of the classroom. Seek schools and work with structured settings, and establish short-term goals.
  • Try scheduling naps if you have narcolepsy.
  • Check with your doctor if you think you may have become dependent on amphetamine.
  • Augment treatment with biofeedback, cognitive-behavioral therapy, educational skills training, parenting skills, and/or social skills.

How to Use This Drug [top]

  • 1If you miss a dose of a short-acting form, take it within the hour. If remembered later, wait until the next scheduled dose. If you miss a dose of a long-acting form, take it as soon as possible, unless it is too close to bedtime. Otherwise, wait until the following day.
  • Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day. Swallow capsule or tablet in the morning. Take scheduled doses at specified intervals, taking the last dose of short-acting forms at least six hours before bedtime, of long-acting forms 10 to 14 hours before bedtime. Take with or without food, but it is best to be consistent about which way it is taken.
  • For extended-release forms, do not break, chew, or crush this drug. Capsules may be opened and the contents mixed with applesauce, jelly, or ketchup, then swallowed without chewing. Vitamin C (ascorbic acid), present in fruit juice, may reduce absorption.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture or strong light.
  • Do not discontinue taking medication without checking with your doctor, who will likely put you on a tapering schedule.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

acebutolol, acetazolamide, amitriptyline, ammonium chloride, amoxapine, ANAFRANIL, ascorbic acid, ASENDIN, atenolol, AVANDAMET, AVENTYL, BETAGAN, BETAPACE, betaxolol, BETAXON, BETOPTIC, BIOCADREN, bisoprolol, caffeine, cartelol, CARTOL, chlorpromazine, clomipramine, CORGARD, CORZIDE, cyclobenzaprine, DEMEROL, desipramine, DIAMOX, digoxin, doxepin, ELAVIL, ELDEPRYL, FLEXERIL, fruit juices, furazolidone, FUROXONE, GLUCOVANCE, guanethidine, imipramine, INDERAL, INDERIDE, ISMELIN, isocarboxazid, KERLONE, LANOXIN, LEVATOL, LOPRESSOR, LOPRESSOR HTC, MARPLAN, MATULANE, meperidine, METAGLIP, metformin, metipranolol, metoprolol, naldolol, NARDIL, NORPRAMIN, NORTRIPTYLINE, OCUPRESS, OPTIPRANOLOL, orlistat, PAMELOR, PARNATE, penbutolol, PERTOFRANE, phenelzine, pinolol, procarbazine, propranolol, protriptyline, pseudoephedrine (present in numerous cough and cold remedies), SECTRAL, selegiline, SINEQUAN, sotalol, SUDAFED, SURMONTIL, TENORETIC, TENORMIN, THORAZINE, TIMOLIDE, timolol, TIMOPTIC, TOFRANIL, tranylcypromine, trimipramine, VISKAZIDE, VISKEN, vitamin C (especially in high doses),VIVACTIL, XENICAL, ZEBETA, and ZIAC.

Use of amphetamines with monoamine oxidase (MAO) inhibitors can cause dangerous increases in blood pressure, called a hypertensive crisis. Do not take amphetamines within fourteen days of an MAO inhibitor.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • blood pressure increase
  • breathing difficulty
  • chest pain or discomfort
  • dizziness or faintness
  • pounding or irregular heartbeat
  • psychosis (hallucinations)
  • mood or mental changes
  • uncontrolled movements of head, neck, arms, and legs
  • extremely high body temperature
  • unusual tiredness or weakness

Signs of overdose:

  • agitation
  • assaultive behavior
  • blood pressure increase or decrease
  • rapid breathing
  • confusion
  • diarrhea
  • fast, pounding, or irregular heartbeat
  • confusion
  • dry mouth
  • euphoria
  • fever
  • hallucinations
  • severe headache
  • muscle twitch
  • nausea
  • enlarged pupils
  • overactive reflexes
  • panic
  • restlessness
  • shaking
  • stomach cramps
  • increased sweating
  • trembling
  • vomiting

These symptoms may be followed by fatigue and depression.

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Call your doctor if these symptoms continue:

  • appetite decrease
  • constipation
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness, fatigue
  • dry mouth
  • false sense of well-being
  • headache, migraine headache[11]
  • fast or pounding heartbeat
  • trouble sleeping
  • irritability
  • mental depression
  • nausea or vomiting
  • nervousness, restlessness
  • change in sexual desire or ability
  • stomach cramps or pain
  • increased sweating
  • sense of taste becomes unpleasant
  • trembling
  • blurred vision
  • weight loss

Call your doctor if these symptoms continue after you stop taking this drug:

  • mental depression
  • nausea
  • stomach cramps or pain
  • vomiting
  • trembling
  • unusual tiredness or weakness

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

By your doctor:

  • assessment for drug tolerance, blood pressure, electrocardiogram (EKG or ECG), pulse, tics, weight and height, and reassessment for continuing need for therapy, dose of medication, and signs of dependence or abuse
  • standard sleepiness scale, Test of Variables of Attention (TOVA)

By your parent(s):

  • rating scales, such as Achenbach’s Child Behavior Checklist, Conner’s Parent Questionnaire

By your teacher(s):

  • rating scales, such as Child Attention Problems, Conner’s Teacher Rating Scale

last reviewed May 31, 2021