Dexedrine

In the U.S.

• Dexedrine
• Dexedrine Spansules
• Dextrostat
• Liquadd
• ProCentra
• Zenzedi

Available Dosage Forms:

• Capsule, Extended Release
• Solution
• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine (class)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dextroamphetamine tablets to treat attention-deficit hyperactivity disorder in children younger than 3 years of age. Safety and efficacy have not been established.

Dextroamphetamine sustained-release capsule is not recommended to treat attention-deficit hyperactivity disorder in children younger than 6 years of age.

Geriatric

No information is available on the relationship of age to the effects of dextroamphetamine in geriatric patients. .

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Acetazolamide
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cinacalcet
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Anxiety, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Coronary artery disease or
• Drug abuse, history of or
• Glaucoma or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, ventricular arrhythmia) or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of or
• Tension, severe—Should not be used in patients with these conditions.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, Raynaud disease) or
• Depression, or a family history of or
• Hypertension (high blood pressure), mild or
• Mania, history of or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Thyroid problems or
• Tourette's syndrome, or family history of—Use with caution. May make these conditions worse. .

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:

• Agitation
• delusions
• seeing, hearing, or feeling things that are not there

• Blurred vision
• chest discomfort or pain
• difficulty breathing
• dizziness
• faintness
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• headache
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• swelling of the feet or lower legs
• trembling or shaking of the hands or feet
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unable to sleep
• uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Change in consciousness
• dark-colored urine
• diarrhea
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• mood or mental changes
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• panic state
• physical attempt to injure
• rapid breathing
• seizures
• stomach cramps
• sweating
• trouble concentrating
• violent actions
• 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• constipation
• decreased interest in sexual intercourse
• dry mouth
• hives or welts, itching, or skin rash
• inability to have or keep an erection
• indigestion
• loss in sexual ability, desire, drive, or performance
• passing of gas
• redness of the skin
• weight loss

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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Dexedrine affects you.
• If you have been taking this medicine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if Dexedrine stops working well. Do not take more than ordered.
• This medicine may be habit-forming with long-term use.
• If you have been taking this medicine for many weeks, talk with your doctor before stopping. You may want to slowly stop Dexedrine.
• You may have some heart tests before starting this medicine. Talk with your doctor.
• This medicine may cause high blood pressure.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Dexedrine (dextroamphetamine tablets).
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this medicine. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take Dexedrine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Do not give to a child younger than 3 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

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.
• A heartbeat that does not feel normal.
• Very nervous and excitable.
• Restlessness.
• Shakiness.
• Change in sex ability.
• Lowered interest in sex.
• Seizures.
• Dark urine.
• Not able to pass urine or change in how much urine is passed.
• Muscle pain or weakness.
• 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.
• Heart attacks, strokes, and sudden deaths have happened in adults taking Dexedrine. 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.

DESCRIPTION:

Dexedrine (dextroamphetamine sulfate) is the dextro isomer of the compound d,1-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of Dexedrine as the neutral sulfate.

Structural formula:

SPANSULE capsules:
Each SPANSULE sustained-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.
Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 512 on the brown cap and is imprinted 5 mg and ap on the clear body. The 10-mg capsule is imprinted 10 mg513on the brown cap and is imprinted 10 mgapon the clear body. The 15-mg capsule is imprinted 15 mg and 514 on the brown cap and is imprinted 15 mg and ap on the clear body. A narrow bar appears above and below 15 mg and 514. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.

General

The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the possibility of overdosage.

Information for Patients:

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for Dexedrine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]

• Instruct patients beginning treatment with Dexedrine about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
• Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
• Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Dexedrine.
• Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Drug Interactions

Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic blockers are inhibited by amphetamines.

Increase blood levels and potentiate the action of amphetamine. Co-administration of Dexedrine and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides).

May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.

The concomitant use of Dexedrine and CYP2D6 inhibitors may increase the exposure of Dexedrine compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dexedrine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Dexedrine and the CYP2D6 inhibitor [see Warnings, Overdosage]. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

The concomitant use of Dexedrine and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dexedrine initiation or dosage increase. If serotonin syndrome occurs, discontinue Dexedrine and the concomitant serotonergic drug(s) [see Warnings and Precautions]. Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.

Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer Dexedrine concomitantly or within 14 days after discontinuing MAOI [see Contraindications and Warnings]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.

Amphetamines may counteract the sedative effect of antihistamines.

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

The stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Amphetamines potentiate the analgesic effect of meperidine.

Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Amphetamines enhance the adrenergic effect of norepinephrine.

Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening.
Amphetamines may interfere with urinary steroid determinations.

Carcinogenesis/Mutagenesis

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Dexedrine have not been performed.

Pregnancy

Pregnancy Category C. Dexedrine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been 1 report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (VATER association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dexedrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Long-term effects of amphetamines in pediatric patients have not been well established.
Dexedrine is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.
Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulant medications.
Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.
Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his or her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

Cardiovascular

Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette’s syndrome.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Musculoskeletal

Rhabdomyolysis.

Skin and Subcutaneous Tissue Disorders

Alopecia.

Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet

Along with its needed effects, dextroamphetamine (the active ingredient contained in Dexedrine) 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 while taking dextroamphetamine:

• Agitation
• delusions
• seeing, hearing, or feeling things that are not there

• Blurred vision
• chest discomfort or pain
• difficulty breathing
• dizziness
• faintness
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• headache
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• swelling of the feet or lower legs
• trembling or shaking of the hands or feet
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unable to sleep
• uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking dextroamphetamine:

• Change in consciousness
• dark-colored urine
• diarrhea
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• mood or mental changes
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• panic state
• physical attempt to injure
• rapid breathing
• seizures
• stomach cramps
• sweating
• trouble concentrating
• violent actions
• vomiting

Some side effects of dextroamphetamine 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• constipation
• decreased interest in sexual intercourse
• dry mouth
• hives or welts, itching, or skin rash
• inability to have or keep an erection
• indigestion
• loss in sexual ability, desire, drive, or performance
• passing of gas
• redness of the skin
• weight loss

Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet

Metabolic

Very common (10% or more): Decreased appetite, reduced weight gain, weight loss
Common (1% to 10%): Anorexia
Frequency not reported: Acidosis[Ref]

Psychiatric

Very common (10% or more): Insomnia, nervousness
Common (1% to 10%): Abnormal behavior, aggression/hostility, excitation, anxiety, depression, irritability
Uncommon (0.1% to 1%): Psychotic episodes/psychosis
Very rare (less than 0.01%): Suicidal behavior (including completed suicide), mania, hallucinations
Frequency not reported: Overstimulation, restlessness, euphoria, dysphoria, confusion, dependence, emotional lability, impaired cognitive test performance, altered libido, night terrors, obsessive-compulsive behavior, panic states, paranoia[Ref]

Cardiovascular

Common (1% to 10%): Arrhythmia, palpitations, tachycardia
Rare (less than 0.1%): Angina pectoris
Very rare (less than 0.01%): Cardiac arrest
Frequency not reported: Blood pressure and heart rate changes (usually elevated), cardiomyopathy, myocardial infarction, chest pain, cardiovascular collapse, Raynaud's phenomenon[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain and cramps, nausea, vomiting, dry mouth
Frequency not reported: Ischemic colitis, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia
Rare (less than 0.1%): Growth retardation
Very rare (less than 0.01%): Muscle cramps
Frequency not reported: Rhabdomyolysis[Ref]

Nervous system

Common (1% to 10%): Vertigo, dyskinesia, headache, hyperactivity
Very rare (less than 0.01%): Tourette syndrome, tics, exacerbation of pre-existing motor and phonic tics, convulsions, choreoathetoid movements, intracranial hemorrhage, cerebral vasculitis and/or occlusion, neuroleptic malignant syndrome (NMS)
Frequency not reported: Dizziness, tremor, ataxia, dysgeusia, concentration difficulties, hyperreflexia, stroke[Ref]

Dermatologic

Rare (less than 0.1%): Rash, urticaria
Very rare (less than 0.01%): Erythema multiforme, exfoliative dermatitis, fixed drug eruption
Frequency not reported: Sweating, alopecia[Ref]

Ocular

Rare (less than 0.1%): Visual accommodation difficulties, blurred vision, mydriasis[Ref]

Other

Rare (less than 0.1%): Fatigue
Frequency not reported: Hyperpyrexia, sudden death[Ref]

Hematologic

Very rare (less than 0.01%): Anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura[Ref]

Hepatic

Very rare (less than 0.01%): Abnormal liver function ranging from hepatic enzyme elevations to hepatic coma[Ref]

Endocrine

Frequency not reported: Impotence, libido changes, frequent or prolonged erections[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (e.g., angioedema and anaphylaxis)[Ref]

Renal

Frequency not reported: Renal damage[Ref]

Some side effects of Dexedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.