Adderall XR

Name: Adderall XR

Adderall XR Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
Less common
  • Cold or flu-like symptoms
  • cough or hoarseness
  • fever or chills
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chest pain or discomfort
  • confusion
  • dark-colored urine
  • diarrhea
  • difficulty breathing
  • difficulty with speaking
  • difficulty with swallowing
  • dizziness
  • double vision
  • faintness
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching, skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • muscle cramps or spasms
  • muscle pain or stiffness
  • muscle spasm or jerking of all extremities
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seeing, hearing, or feeling things that are not there
  • seizures
  • slow speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • sweating
  • swelling of the feet or lower legs
  • tightness in the chest
  • uncontrolled repeated movements (tics)
  • uncontrolled vocal outbursts
  • unusual tiredness or weakness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Anxiety
  • dry mouth
  • lack or loss of strength
  • stomach pain
  • weight loss
Incidence not known
  • Constipation
  • decreased interest in sexual intercourse
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • Very nervous and excitable.
  • Change in sex ability.
  • Lowered interest in sex.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Trouble controlling body movements.
  • Restlessness.
  • Change in eyesight.
  • For males, erections (hard penis) that happen often or that last a long time.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Heart attacks, strokes, and sudden deaths have happened in adults taking this medicine. Sudden deaths have also happened in children with very bad heart problems or heart defects. Call your doctor right away if you have a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.

What are some other side effects of Adderall XR?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Feeling nervous and excitable.
  • Headache.
  • Not hungry.
  • Not able to sleep.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dizziness.
  • Dry mouth.
  • Bad taste in your mouth.
  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Clinical Studies

Pediatric Patients

A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 6-12 (N=584) who met DSM-IV® criteria for ADHD (either the combined type or the hyperactive-impulsive type). Patients were randomized to fixed-dose treatment groups receiving final doses of 10, 20, or 30 mg of Adderall XR or placebo once daily in the morning for three weeks. Significant improvements in patient behavior, based upon teacher ratings of attention and hyperactivity, were observed for all Adderall XR doses compared to patients who received placebo, for all three weeks, including the first week of treatment, when all Adderall XR subjects were receiving a dose of 10 mg/day. Patients who received Adderall XR showed behavioral improvements in both morning and afternoon assessments compared to patients on placebo.

In a classroom analogue study, patients (N=51) receiving fixed doses of 10 mg, 20 mg or 30 mg Adderall XR demonstrated statistically significant improvements in teacher-rated behavior and performance measures, compared to patients treated with placebo.

A double-blind, randomized, multi-center, parallel-group, placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who met DSM-IV® criteria for ADHD. The primary cohort of patients (n=287, weighing ≤ 75kg/165lbs) was randomized to fixed-dose treatment groups and received four weeks of treatment. Patients were randomized to receive final doses of 10 mg, 20 mg, 30 mg, and 40 mg Adderall XR or placebo once daily in the morning. Patients randomized to doses greater than 10 mg were titrated to their final doses by 10 mg each week. The secondary cohort consisted of 40 subjects weighing >75kg/165lbs who were randomized to fixed-dose treatment groups receiving final doses of 50 mg and 60 mg Adderall XR or placebo once daily in the morning for 4 weeks. The primary efficacy variable was the Attention Deficit Hyperactivity Disorder-Rating Scale IV (ADHD-RS-IV) total score for the primary cohort. The ADHD-RS-IV is an 18-item scale that measures the core symptoms of ADHD. Improvements in the primary cohort were statistically significantly greater in all four primary cohort active treatment groups (Adderall XR 10 mg, 20 mg, 30 mg, and 40 mg) compared with the placebo group. There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit.

Adult Patients

A double-blind, randomized, placebo-controlled, parallel-group study was conducted in adults (N=255) who met DSM-IV® criteria for ADHD. Patients were randomized to fixed-dose treatment groups receiving final doses of 20, 40, or 60 mg of Adderall XR or placebo once daily in the morning for four weeks. Significant improvements, measured with the Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS), an 18- item scale that measures the core symptoms of ADHD, were observed at endpoint for all Adderall XR doses compared to patients who received placebo for all four weeks. There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit.

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

NDC 54092-383-01

Adderall XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

10 mg

CII
100 Capsules

Rx only

Shire

015925

LOT
EXP

In Summary

Common side effects of Adderall XR include: headache, insomnia, weight loss, anorexia, and xerostomia. Other side effects include: nausea, and emotional lability. See below for a comprehensive list of adverse effects.

What is the most important information I should know about Adderall XR (amphetamine and dextroamphetamine)?

Amphetamine and dextroamphetamine may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use this medivine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine and dextroamphetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems--unexplained wounds on your fingers or toes.

You may not be able to use this medicine if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.

What should I discuss with my healthcare provider before taking Adderall XR (amphetamine and dextroamphetamine)?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You may not be able to use amphetamine and dextroamphetamine if you are allergic to any stimulant medicine. You may not be able to use this medicine if you have:

  • high blood pressure, heart disease, coronary artery disease (hardened arteries);

  • overactive thyroid;

  • glaucoma;

  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

  • a history of drug or alcohol addiction.

Some medicines can interact with amphetamine and dextroamphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

  • heart problems or a congenital heart defect;

  • high blood pressure; or

  • a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

  • depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

  • motor tics (muscle twitches) or Tourette's syndrome;

  • seizures or epilepsy;

  • an abnormal brain wave test (EEG); or

  • blood circulation problems in the hands or feet.

Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

Amphetamine and dextroamphetamine is not approved for use by anyone younger than 6 years old.

Pregnancy & Lactation

Pregnancy category: C

Lactation: Not recommended; found in breast milk; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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