Note: This document contains side effect information about dextroamphetamine. Some dosage forms listed on this page may not apply to the brand name Zenzedi.

Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet. Other dosage forms:

• transdermal patch extended release

Serious side effects of Zenzedi

Along with its needed effects, dextroamphetamine (the active ingredient contained in Zenzedi) 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:

Rare

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

Incidence not known

• Blurred vision
• chest discomfort or pain
• constipation
• diarrhea
• difficulty breathing
• dizziness
• faintness
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• headache
• nausea
• pounding in the ears
• shakiness in the legs, arms, hands, or feet
• stomach pain
• 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
• vomiting

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

Symptoms of overdose

• Aggressive
• angry
• confusion
• dark urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast breathing
• fast, slow, or irregular heartbeat
• loss of consciousness
• muscle cramps, spasms, pain, or stiffness
• nausea
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• stomach cramps
• sweating
• tremor
• unusual tiredness or weakness
• vomiting

Other side effects of Zenzedi

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:

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• change in taste
• 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

For Healthcare Professionals

Applies to dextroamphetamine: oral capsule extended release, oral solution, oral tablet, transdermal film.

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]