Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.
Warning
Oral route (Capsule)
CNS stimulants, including serdexmethylphenidate/dexmethylphenidate, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
Serious side effects
Along with its needed effects, dexmethylphenidate / serdexmethylphenidate 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 dexmethylphenidate / serdexmethylphenidate:
More common
- Actions that are out of control
- anxiety
- blurred vision
- chest pain or discomfort
- confusion
- difficulty in speaking
- dizziness
- double vision
- enlarged pupils
- false beliefs that cannot be changed by facts
- fast, slow, pounding, or irregular heartbeat or pulse
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold, clammy skin
- irritability
- lack or slowing of normal growth in children
- loss in sexual ability, desire, drive, or performance
- nausea
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- stiff or sore neck
- talking, feeling, and acting with excitement
- trouble breathing
- trouble sleeping
- vomiting
- weight loss
Incidence not known
- Agitation
- arm, jaw, or back pain
- bleeding gums
- blood in the urine or stools
- bloody nose
- bloody, black, or tarry stools
- chest tightness or heaviness
- chills
- cough
- dark-colored urine
- decreased interest in sexual intercourse
- diarrhea
- difficulty in moving
- difficulty swallowing
- double vision
- dry mouth
- extra heartbeats
- fainting
- feeling of constant movement of self or surroundings
- fever
- hair loss, thinning of hair
- heavier menstrual periods
- hives, itching, skin rash
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- light-colored stools
- lightheadedness
- muscle aches, cramps, pain, stiffness, or twitching
- overactive reflexes
- pain in the joints
- painful or prolonged erection of the penis
- pale skin
- paleness or cold feeling in the fingertips and toes
- pinpoint red spots on the skin
- poor coordination
- redness of the skin
- restlessness
- seeing double
- seizures
- sensation of spinning
- shakiness in the legs, arms, hands, feet
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- swollen joints
- tingling or pain in the fingers or toes when exposed to cold
- trembling or shaking of the hands or feet
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking dexmethylphenidate / serdexmethylphenidate:
Symptoms of overdose
- Bigger, dilated, or enlarged pupils
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- false or unusual sense of well-being
- flushing
Other side effects
Some side effects of dexmethylphenidate / serdexmethylphenidate 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
- Acid or sour stomach
- belching
- decreased appetite
- heartburn
- indigestion
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.
General
The more commonly reported adverse reactions with methylphenidate products have included decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.[Ref]
Cardiovascular
Increased blood pressure, and tachycardia have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD (Attention Deficit Hyperactivity Disorder) and at least twice the rate of placebo.
Methylphenidate products:
Frequency not reported: Increased blood pressure, tachycardia
Postmarketing reports: Angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate, chest pain, chest discomfort, Raynaud's phenomenon
Hypersensitivity
Frequency not reported: Bronchospasm, rash, pruritus
Methylphenidate products:
Postmarketing reports: Hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, eruptions, exanthemas
Psychiatric
Insomnia, anxiety, affect lability, and irritability have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.
Methylphenidate products:
Postmarketing reports: Disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation
Methylphenidate Products:
Frequency not reported: Insomnia, anxiety, affect lability, irritability
Musculoskeletal
Frequency not reported: Lower than expected increases in height and weight
Methylphenidate products:
Postmarketing reports: Arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps
In an open label safety study with this drug, growth in pediatric patients 6 to 12 years of age was assessed and compared to age and sex matched population standards. The mean increase in weight from baseline to Month 12 was 3.4 kg among study completers. The mean change in z-score from baseline to Month 12 was -0.2, indicating a lower-than-expected increase in body weight. Most of the weight z-score decline occurred in the first 4 months of treatment. The mean increase in height from baseline to Month 12 was 4.9 cm among completers. Using the same z-score analysis for height, the mean change in z-score from baseline to Month 12 was - 0.21, indicating a lower-than-expected increase in height compared to pediatric patients of the same age and sex.
Metabolic
Methylphenidate Products:
Frequency not reported: Decreased appetite, weight loss
Decreased appetite and weight loss have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.
Gastrointestinal
Nausea, abdominal pain, dyspepsia, and vomiting have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.
Methylphenidate Products:
Frequency not reported: Nausea, abdominal pain, dyspepsia, vomiting
Postmarketing reports: Dry mouth
Genitourinary
Methylphenidate products:
Postmarketing reports: Priapism
Nervous system
Dizziness was reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.
Methylphenidate Products:
Frequency not reported: Dizziness
Postmarketing reports: Convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo
Hematologic
Methylphenidate Products:
Postmarketing reports: Pancytopenia, thrombocytopenia, thrombocytopenic purpura, platelet count decreased, white blood cell counts abnormal
Ocular
Methylphenidate products
Postmarketing reports: Diplopia, mydriasis, visual impairment, blurred vision
Hepatic
Methylphenidate products:
Postmarketing reports: Hepatocellular injury, acute hepatic failure, alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased
Other
Methylphenidate products
Postmarketing reports: Hyperpyrexia
Dermatologic
Methylphenidate products:
Postmarketing reports: Alopecia, erythema, hyperhidrosis
