Adderall XR Capsules
- Generic Name: amphetamine, dextroamphetamine mixed salts
- Brand Name: Adderall XR
Adderall XR(Amphetamine, Dextroamphetamine Mixed Salts) side effects drug center
Adderall XR Capsules Side Effects Center
What Is Adderall XR?
Adderall XR (amphetamine and dextroamphetamine salts) is a central nervous system (CNS) stimulant used for treating attention deficit hyperactivity disorder (ADHD) and narcolepsy.
What Are Side Effects of Adderall XR?
Side effects of Adderall XR include
- nervousness,
- restlessness,
- excitability,
- dizziness,
- headache,
- weakness,
- fear,
- anxiety,
- irritability,
- agitation,
- blurred vision,
- sleep problems (insomnia),
- dry mouth,
- unpleasant taste in mouth,
- diarrhea,
- constipation,
- stomach pain,
- nausea,
- vomiting,
- fever,
- hair loss,
- loss of appetite,
- weight loss,
- tremor,
- loss of interest in sex,
- impotence,
- difficulty having an orgasm,
- increased blood pressure,
- increased heart rate, and
- palpitations.
Adderall XR is habit forming and chronic use may lead to dependence.
Dosage for Adderall XR
Adderall XR is available as capsules in the following dosages: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
Dosage depends on the therapeutic needs and response of the patient.
What Drugs, Substances, or Supplements Interact with Adderall XR?
Adderall may interact with heart or blood pressure medications, diuretics (water pills), cold or allergy medicines (antihistamines), acetazolamide, chlorpromazine, ethosuximide, haloperidol, lithium, meperidine, methenamine, phenytoin , phenobarbital, reserpine, ammonium chloride, ascorbic acid (vitamin C), potassium phosphate, antacids, sodium bicarbonate (Alka-Seltzer), potassium citrate, sodium citrate and citric acid, sodium citrate and potassium, stomach acid reducers, or antidepressants. Tell your doctor all medications and supplements you use.
Additional Information
Our Adderall XR Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Adderall XR Capsules Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
- signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
- signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
- a seizure (convulsions);
- muscle twitches (tics); or
- changes in your vision.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Long-term use of stimulant medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
- stomach pain, nausea, loss of appetite;
- weight loss;
- mood changes, feeling nervous or irritable;
- fast heart rate;
- headache, dizziness;
- sleep problems (insomnia); or
- dry mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Adderall XR Capsules (Amphetamine, Dextroamphetamine Mixed Salts)
Adderall XR Capsules Professional Information
SIDE EFFECTS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Studies Experience
The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.
Adverse Reactions Leading to Discontinuation of Treatment
In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of ADDERALL XR-treated patients discontinued due to adverse reactions (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo.
The most frequent adverse reactions leading to discontinuation of ADDERALL XR in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to ADDERALL XR for 12 months or more.
In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatment due to adverse events among ADDERALL XR-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness (1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).
Adverse Reactions Occurring in Controlled Trials
Adverse reactions reported in a 3-week clinical trial of children and a 4-week clinical trial in adolescents and adults, respectively, treated with ADDERALL XR or placebo are presented in the tables below.
Table 1 : Adverse Reactions Reported by 2% or More of
Children (6-12 Years Old) Receiving ADDERALL XR with Higher Incidence Than on
Placebo in a 584-Patient Clinical Study
| Body System | Preferred Term | ADDERALL XR (n=374) |
Placebo (n=210) |
| General | Abdominal Pain (stomachache) | 14% | 10% |
| Fever | 5% | 2% | |
| Infection | 4% | 2% | |
| Accidental Injury | 3% | 2% | |
| Asthenia (fatigue) | 2% | 0% | |
| Digestive System | Loss of Appetite | 22% | 2% |
| Vomiting | 7% | 4% | |
| Nausea | 5% | 3% | |
| Dyspepsia | 2% | 1% | |
| Nervous System | Insomnia | 17% | 2% |
| Emotional Lability | 9% | 2% | |
| Nervousness | 6% | 2% | |
| Dizziness | 2% | 0% | |
| Metabolic/ Nutritional | Weight Loss | 4% | 0% |
Table 2 : Adverse Reactions Reported by 5% or More of
Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving ADDERALL
XR with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose
Titration Study*
| Body System | Preferred Term | ADDERALL XR (n=233) |
Placebo (n=54) |
| General | Abdominal Pain (stomachache) | 11% | 2% |
| Digestive System | Loss of Appetiteb | 36% | 2% |
| Nervous System | Insomniab | 12% | 4% |
| Nervousness | 6% | 6%a | |
| Metabolic/ Nutritional | Weight Lossb | 9% | 0% |
| *Included doses up to 40 mg a Appears the same due to rounding b Dose-related adverse reactions Note: The following reactions did notmeet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting. |
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Table 3 : Adverse Reactions Reported by 5% or More of
Adults Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 255
Patient Clinical Forced Weekly-Dose Titration Study*
| Body System | Preferred Term | ADDERALL XR (n=191) |
Placebo (n=64) |
| General | Headache | 26% | 13% |
| Asthenia | 6% | 5% | |
| Digestive System | Dry Mouth | 35% | 5% |
| Loss of Appetite | 33% | 3% | |
| Nausea | 8% | 3% | |
| Diarrhea | 6% | 0% | |
| Nervous System | Insomnia | 27% | 13% |
| Agitation | 8% | 5% | |
| Anxiety | 8% | 5% | |
| Dizziness | 7% | 0% | |
| Nervousness | 13% | 13%a | |
| Cardiovascular System | Tachycardia | 6% | 3% |
| Metabolic/ Nutritional | Weight Loss | 10% | 0% |
| Urogenital System | Urinary Tract Infection | 5% | 0% |
| *Included doses up to 60 mg. a Appears the same due to rounding Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving ADDERALL XR with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence. |
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Hypertension
[see WARNINGS AND PRECAUTIONS]
In a controlled 4-week outpatient clinical study of adolescents with ADHD, isolated systolic blood pressure elevations ≥ 15 mmHg were observed in 7/64 (11%) placebotreated patients and 7/100 (7%) patients receiving ADDERALL XR 10 or 20 mg. Isolated elevations in diastolic blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated patients and 22/100 (22%) ADDERALL XR-treated patients. Similar results were observed at higher doses.
In a single-dose pharmacokinetic study in 23 adolescents with ADHD, isolated increases in systolic blood pressure (above the upper 95% CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%), subjects administered 10 mg and 20 mg ADDERALL XR, respectively. Higher single doses were associated with a greater increase in systolic blood pressure. All increases were transient, appeared maximal at 2 to 4 hours post dose and not associated with symptoms.
Adverse Reactions Associated With The Use of Amphetamine, ADDERALL XR, Or ADDERALL
The following adverse reactions have been associated with the use of amphetamine, ADDERALL XR, or ADDERALL:
Cardiovascular
Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), and bruxism.
Eye Disorders
Vision blurred, mydriasis.
Gastrointestinal
Unpleasant taste, constipation, other gastrointestinal disturbances.
Allergic
Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.
Endocrine
Impotence, changes in libido, frequent or prolonged erections.
Skin
Alopecia.
Vascular Disorders
Musculoskeletal and Connective Tissue Disorders
Read the entire FDA prescribing information for Adderall XR Capsules (Amphetamine, Dextroamphetamine Mixed Salts)
&Copy; Adderall XR Capsules Patient Information is supplied by Cerner Multum, Inc. and Adderall XR Capsules Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.