Relexxii Side Effects

Generic name: methylphenidate

Medically reviewed by Drugs.com. Last updated on Apr 30, 2024.

Note: This document provides detailed information about Relexxii Side Effects associated with methylphenidate. Some dosage forms listed on this page may not apply specifically to the brand name Relexxii.

Applies to methylphenidate: oral capsule extended release, oral capsule extended release biphasic 30/70, oral capsule extended release biphasic 40/60, oral capsule extended release biphasic 50/50, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable, oral tablet extended release disintegrating.

Other dosage forms:

• transdermal patch extended release

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you are using or have used a drug for depression, called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child has chest pain, trouble breathing, fainting, or a fast, irregular heartbeat while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, including an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you feel, see, or hear things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of his height and weight to make sure that he is growing properly.

Methylphenidate may cause a condition called Raynaud's phenomenon. Check with your doctor right away if you or your child has tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Make sure any doctor or dentist who treats you knows that you are using Metadate CD®, Relexxii®, Ritalin®, Ritalin LA®, or Ritalin-SR®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while using Concerta®, Cotempla XR-ODT™ extended release disintegrating tablets, Adhansia XR®, Aptensio XR™, Metadate CD®, or Ritalin LA® extended-release capsules, Quillichew ER™ extended-release chewable tablets, or Quillivant® XR extended-release suspension.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Adhansia XR® contains a yellow dye called tartrazine, which may cause severe allergic reactions. Tell your doctor if you have any allergies (including an aspirin allergy).

Symptoms of overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine, including irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Serious side effects of Relexxii

Along with its needed effects, methylphenidate (the active ingredient contained in Relexxii) 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 methylphenidate:

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

Symptoms of overdose

• agitation
• anxiety
• bigger, dilated, or enlarged pupils of the eyes
• blurred vision
• change in consciousness
• chest pain or discomfort
• confusion as to time, place, or person
• dark urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• holding false beliefs that cannot be changed by fact
• inability to speak
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle pain, cramps, stiffness, or twitching
• nausea
• nervousness
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• pale, clammy skin
• palpitations
• pounding in the ears
• rapid, shallow breathing
• seeing, hearing, or feeling things that are not there
• seizures
• shivering
• slurred speech
• sweating
• talking or acting with excitement you cannot control
• temporary blindness
• thirst
• trembling or shaking
• trouble breathing
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

Other side effects of Relexxii

Some side effects of methylphenidate 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:

For healthcare professionals

Applies to methylphenidate: oral capsule extended release, oral powder for reconstitution extended release, oral solution, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet disintegrating extended release, oral tablet extended release, transdermal film extended release.

General adverse events

The more commonly reported adverse reactions have included decreased appetite, abdominal pain, nausea, vomiting, dyspepsia, insomnia, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.^[Ref]

Other

• Common (1% to 10%): Lethargy, ear infection, pyrexia, fatigue, ear and labyrinth disorders, asthenia, injury/poisoning/procedural complications
• Postmarketing reports: Hyperpyrexia^[Ref]

Psychiatric

• Very common (10% or more): Psychiatric disorders (27.9%), insomnia (13.3%), irritability (11%)
• Common (1% to 10%): Anxiety, restlessness, sleep disorder, agitation, affect lability, aggression, depression, depressed mood, abnormal behavior, bruxism, confusional state, initial insomnia, decreased libido, nervousness, emotional poverty, tension, panic attack
• Uncommon (0.1% to 1%): Psychotic disorders, hallucinations (auditory, visual, tactile), anger, suicidal ideation, altered mood, mood swings, tearfulness, tics, worsening of pre-existing tics or Tourette's syndrome, hypervigilance
• Rare (less than 0.1%): Mania, disorientation, libido disorder
• Very rare (less than 0.01%): Suicidal attempt/completed suicide, transient depressed mood, abnormal thinking, apathy, repetitive behaviors, over-focusing
• Frequency not reported: Delusions, thought disturbances, confessional state, logorrhea^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (27.1%), metabolism and nutrition disorders (11.5%)
• Common (1% to 10%): Anorexia, decreased weight, thirst^[Ref]

Gastrointestinal

• Very common (10% or more): Gastrointestinal disorders (23.5%), dry mouth (21.5%), nausea (12.2%), vomiting (10.2%)
• Common (1% to 10%): Abdominal pain (upper and general), diarrhea, dyspepsia, toothache, stomach discomfort
• Uncommon (0.1% to 1%): Constipation^[Ref]

Nervous system

• Very common (10% or more): Nervous system disorders (23.5%), headache (23.2%)
• Common (1% to 10%): Dizziness, dyskinesia, tremor, drowsiness, feeling jittery, psychomotor hyperactivity, somnolence, vertigo, paresthesia, motion sickness, tension headache
• Uncommon (0.1% to 1%): Sedation, tremor
• Very rare (less than 0.01%): Convulsions, choreoathetoid movements, reversible ischemic neurological deficit, cerebrovascular disorders (vasculitis, cerebral hemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), neuroleptic malignant syndrome (NMS)
• Frequency not reported: Grand mal convulsions, migraine, sedation, serotonin syndrome (in combination with serotonergic drugs)^[Ref]

Endocrine

• Common (1% to 10%): Reproductive system and breast disorders
• Rare (less than 0.1%): Gynecomastia

Respiratory

• Very common (10% or more): Nasopharyngitis (19.1%), respiratory/thoracic/mediastinal disorders (10.6%)
• Common (1% to 10%): Upper respiratory tract infection, cough, oropharyngeal/pharyngolaryngeal pain, sinusitis, dyspnea^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal and connective tissue disorders (14.4%),
• Common (1% to 10%): Joint sprain, arthralgia
• Uncommon (0.1% to 1%): Myalgia, muscle twitching, muscle tightness, muscle spasms
• Very rare (less than 0.01%): Muscle cramps
• Frequency not reported: Rhabdomyolysis, growth suppression, arthralgia^[Ref]

Among patients 7 to 10 years old, consistently medicated (i.e., receiving methylphenidate for 7 days per week) for over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated patients over 36 months (ages of 10 to 13 years), a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), has been observed compared to non-medicated patients. This slowing in growth rate has been observed without evidence of growth rebound.^[Ref]

Local

• Very common (10% or more): Administration site and general disorders (12.9%)
• Postmarketing reports: Patch application site reactions^[Ref]

Cardiovascular

• Common (1% to 10%): Palpitations, tachycardia, cardiac disorders, vascular disorders, arrhythmias, hypertension, hot flush, changes in blood pressure and heart rate (usually an increase)
• Uncommon (0.1% to 1%): Cardiac murmur
• Rare (less than 0.1%): Angina pectoris
• Very rare (less than 0.01%): Cardiac arrest, myocardial infarction, peripheral coldness, Raynaud's phenomenon, sudden cardiac death
• Frequency not reported: Supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles
• Postmarketing reports: Angina pectoris, bradycardia extrasystole, supraventricular tachycardia, ventricular extrasystole, chest pain, chest discomfort^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus, urticaria, fever, scalp hair loss/alopecia, dermatitis, excoriation hyperhidrosis, skin and subcutaneous tissue disorders
• Uncommon (0.1% to 1%): Angioneurotic edema, bullous conditions, exfoliative conditions
• Rare (less than 0.1%): Macular rash, erythema
• Very rare (less than 0.01%): Thrombocytopenic purpura, exfoliative dermatitis, erythema multiforme, fixed drug eruption^[Ref]

Immunologic

• Very common (10% or more): Infections and infestations (45.2%)
• Common (1% to 10%): Immune systems disorders, influenza^[Ref]

Ocular

• Common (1% to 10%): Eye disorders, eye pain
• Uncommon (0.1% to 1%): Diplopia, blurred vision
• Rare (less than 0.1%): Visual accommodation difficulties, mydriasis, visual disturbance
• Frequency not reported: Dry eye
• Postmarketing reports: Visual impairment, mydriasis, diplopia^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Hematuria, pollakiuria
• Frequency not reported: Increased erection, prolonged erection, priapism^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic enzyme elevations
• Very rare (less than 0.01%): Abnormal liver function, hepatic coma, increased blood alkaline phosphatase, increased blood bilirubin
• Postmarketing reports: Hepatocellular injury, acute hepatic failure^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions (angioedema, anaphylaxis, auricular swelling, exanthemas)^[Ref]

Hematologic

• Very rare (less than 0.01%): Leukopenia, thrombocytopenia, anemia, decreased platelet count, abnormal white blood count
• Postmarketing reports: Pancytopenia, thrombocytopenia, thrombocytopenia purpura^[Ref]

See also:

Frequently asked questions

• What is metilfenidato used for?
• Ritalin vs Vyvanse - What's the difference between them?
• Concerta vs Adderall - What's the difference between them?
• What are the brands of methylphenidate?
• Jornay PM vs other methylphenidate formulations - how do they compare?
• How is Cotempla XR-ODT different to other brands of methylphenidate?

Further information

Relexxii side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer