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

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

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]

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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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer