Adderall XR Side Effects
Please note - some side effects for Adderall XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Adderall XR - for the Consumer
Adderall XR Extended-Release Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Adderall XR Extended-Release Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Adderall XR Extended-Release Capsules:Constipation; diarrhea; dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; restlessness; stomach pain or upset; trouble sleeping; unpleasant taste; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision problems; change in sexual ability or desire; chest pain; confusion; fainting; fast or irregular heartbeat; fever, chills, or sore throat; new or worsening mental or mood problems (eg, aggression, anxiety, delusions, depression, hallucination, hostility); numbness or tingling of an arm or leg; one-sided weakness; painful or frequent urination; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache; severe stomach pain; severe weight loss; shortness of breath; sudden, severe dizziness or vomiting; slurred speech; uncontrolled muscle movement; unusual weakness or tiredness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAdderall XR Side Effects - for the Professional
Adderall XR
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.
| Body System | Preferred Term | Adderall XR (n=374) |
Placebo (n=210) |
|---|---|---|---|
| General | Abdominal Pain (stomachache) Fever Infection Accidental Injury Asthenia (fatigue) |
14% 5% 4% 3% 2% |
10% 2% 2% 2% 0% |
| Digestive System | Loss of Appetite Vomiting Nausea Dyspepsia |
22% 7% 5% 2% |
2% 4% 3% 1% |
| Nervous System | Insomnia Emotional Lability Nervousness Dizziness |
17% 9% 6% 2% |
2% 2% 2% 0% |
| Metabolic/Nutritional | Weight Loss | 4% | 0% |
| Body System | Preferred Term | Adderall XR (n=233) |
Placebo (n=54) |
|---|---|---|---|
| *Included doses up to 40 mg a Appears the same due to rounding b Dose-related adverse reactions Note: The following reactions did not meet 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. |
|||
| General | Abdominal Pain (stomachache) | 11% | 2% |
| Digestive System | Loss of Appetite b | 36% | 2% |
| Nervous System | Insomnia b Nervousness |
12% 6% |
4% 6%a |
| Metabolic/Nutritional | Weight Loss b | 9% | 0% |
| Body System | Preferred Term | Adderall XR (n=191) |
Placebo (n=64) |
|---|---|---|---|
| *Included doses up to 60 mg. 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. |
|||
| General | Headache Asthenia |
26% 6% |
13% 5% |
| Digestive System | Dry Mouth Loss of Appetite Nausea Diarrhea |
35% 33% 8% 6% |
5% 3% 3% 0% |
| Nervous System | Insomnia Agitation Anxiety Dizziness |
27% 8% 8% 7% |
13% 5% 5% 0% |
| Cardiovascular System | Tachycardia | 6% | 3% |
| Metabolic/Nutritional | Weight Loss | 11% | 0% |
| Urogenital System | Urinary Tract Infection | 5% | 0% |
Hypertension [seeWARNINGS AND PRECAUTIONS (5.1)]
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%) placebo-treated 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.
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.
Skin
Alopecia.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have included dry mouth (35%), loss of appetite (33%), nausea (8%), diarrhea (6%), unpleasant taste, constipation, (undesired) anorexia, weight loss, and other disturbances.
Nervous system
Nervous system side effects have included insomnia (27%), agitation (8%), anxiety (8%), dizziness (7%), depression, seizures, stroke, overstimulation, restlessness, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette's syndrome.
It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, amphetamine-dextroamphetamine) have a role in either the development or worsening of tic disorders such as Tourette's syndrome. According to several case reports, use of CNS stimulant medications may have precipitated or exacerbated tic disorders in some patients with ADHD. Based on these cases, in Tourette's-susceptible patients, CNS stimulants may exacerbate motor and phonic tics that do not subside following discontinuation of the offending agent. In several controlled studies involving patients with ADHD and tic disorders, in the majority of patients, tics did not increase following use of CNS stimulants. In addition, controlled studies have not found that methylphenidate worsens motor tics in Tourette's syndrome nor has it increased tics in patients without Tourette's. However, it should be noted that tics were reported in 7% of patients using the methylphenidate patch compared to 1% to those taking it orally. Additional studies are required in order to clarify this association.
Metabolic
Metabolic side effects including weight loss (11%) have been reported.
Cardiovascular
Cardiovascular side effects have included tachycardia (6%), palpitations, elevated blood pressure, sudden death, and myocardial infarction. There are isolated reports of cardiomyopathy associated with chronic amphetamine use.
Genitourinary
Genitourinary side effects including urinary tract infection (5%), dysmenorrhea, and impotence have been reported.
Other
Other side effects have included a significant elevation (highest in the evening) of the plasma corticosteroid levels. Amphetamines may interfere with urinary steroid determination. Headache (26%), asthenia (6%), somnolence, infection, tooth disorder, speech disorder, and twitching have also been reported.
Dermatologic
Dermatologic side effects have included urticaria, photosensitivity reaction, and sweating.
Endocrine
Endocrine side effects have included impotence and changes in libido.
Psychiatric
Psychiatric side effects including emotional lability and psychotic episodes have been reported rarely at recommended doses.
Respiratory
Respiratory side effects including dyspnea have been reported.
Hypersensitivity
Hypersensitivity side effects have included urticaria.
TopMore Adderall XR resources
- Adderall XR Prescribing Information (FDA)
- Adderall XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Adderall XR Advanced Consumer (Micromedex) - Includes Dosage Information
- Adderall MedFacts Consumer Leaflet (Wolters Kluwer)
- Adderall Prescribing Information (FDA)
- Adderall Monograph (AHFS DI)
- Adderall Consumer Overview
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