Adderall and Adderall XR Extended-Release Capsules
This is a
summary of the most important information about Adderall and
Adderall XR. For details, talk to your healthcare professional.
FDA ALERT [08/2005] Health Canada Announces Return of Adderall to the Canadian Market
Adderall will return to the Canadian market for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (see alert of 02/09/0 below). The Canadian Product Monograph will be revised to include warnings about the misuse of Adderall and that Adderall generally should not be used in patients with structural cardiac abnormalities.
FDA ALERT [02/2005] Health Canada Suspends Marketing of Adderall
Health Canada has suspended marketing of Adderall XR products from
the Canadian market due to concern about reports of sudden
unexplained death (SUD) in children taking Adderall and Adderall
XR. SUD has been associated with amphetamine abuse and reported
in children with underlying cardiac abnormalities taking
recommended doses of amphetamines, including Adderall and Adderall
XR. In addition, a very small number of cases of SUD have been
reported in children without structural cardiac abnormalities
taking Adderall. At this time, FDA cannot conclude that
recommended doses of Adderall can cause SUD, but is continuing to
carefully evaluate these data.
Adderall labeling contains a serious warning
about the potential for abuse.
WARNING: ABUSE POTENTIAL
Amphetamines have a high potential for abuse. Taking
amphetamines for long periods of time may lead to drug
addiction. Particular attention should be paid to the
possibility of people obtaining amphetamines for
non-therapeutic use or distribution to others.
Misuse of amphetamine may cause sudden death and serious
cardiovascular adverse events.
What Is Adderall XR?
Adderall is a
central nervous system stimulant (amphetamine). Adderall is used
to treat attention deficit hyperactivity disorder (ADHD) in
children 6 years of age and older and in adults.
Not Take Adderall ?
You should not take Adderall if you have:
Never take Adderall if you are taking a drug
used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI),
or if you have stopped taking an MAOI in the last 14 days. Taking
Adderall close in time to an MAOI can result in serious,
sometimes fatal, reactions, including:
- High body temperature
- Seizures (convulsions)
MAOI drugs include Nardil (phenelzine
sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxid),
and other brands.
What Are The Risks?
- Worsening mental illness (psychosis): Adderall may
make symptoms of existing mental illness worse.
- Possible decreased growth and weight loss: Adderall
may decrease growth and cause weight loss. Children who take it
for a long time should have their growth and body weight
Increased tics: Adderall may worsen tics and Tourette’s
- Pregnancy: Tell your healthcare professional if you
are or may be pregnant because your baby may be premature or
have a low birth weight. Also, your baby may show withdrawal
symptoms, such as agitation and drowsiness.
- Breast feeding: Do not breast feed while taking
Adderall because it can pass into your breast milk.
- Other side effects include loss of appetite,
difficulty sleeping, dry mouth, headaches, and mood changes.
- Tell your healthcare professional about any medical
conditions you have in addition to those already mentioned in
this information sheet.
Are There Any Interactions With Drugs or Foods?
- Adderall may interact with other medicines. These
interactions can cause serious side effects. Tell your
healthcare professional about all medicines, vitamins, and
herbal supplements you take, especially:
- Those used to treat depression, known as tricyclic
antidepressants and monoamine oxidase inhibitors (MAOI)
- Those used to treat urinary problems
- Propoxyphene (Darvon, Darvocet), a pain medicine
Do I Take Adderall ?
- Adderall is taken by mouth, in the morning, with or without
food, exactly as prescribed by your healthcare professional.
- Swallow Adderall capsules whole or open the capsule and
sprinkle the contents on a spoonful of applesauce. Take right
away without chewing.
Adderall XR FDA
Patient Information Sheet Revised 2/9/2005
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
Date created: February 9, 2005; updated September 23, 2005