Carbex Side Effects

Generic name: selegiline

Medically reviewed by Drugs.com. Last updated on Oct 1, 2023.

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

Applies to selegiline: transdermal patch extended release.

Other dosage forms:

• oral capsule, oral tablet, oral tablet disintegrating

Important warnings This medicine can cause some serious health issues

Transdermal route (patch, extended release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders.

Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

This risk must be balanced with the clinical need.

Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior.

Families and caregivers should be advised of the need for close observation and communication with the prescriber.

The transdermal patch should not be used in pediatric patients under the age of 12, at any dose, even with dietary modifications.

Serious side effects of Carbex

Along with its needed effects, selegiline (the active ingredient contained in Carbex) 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 selegiline:

More common

• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• headache
• sleeplessness
• trouble sleeping
• unable to sleep

Other side effects of Carbex

Some side effects of selegiline 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

• burning, itching, redness, skin rash, swelling, or soreness at site
• diarrhea
• dry mouth

Less common

• acid or sour stomach
• belching
• body aches or pain
• change or problem with discharge of semen
• congestion
• cough
• dryness or soreness of throat
• fever
• heartburn
• hoarseness
• indigestion
• pain or tenderness around eyes and cheekbones
• rash
• runny nose
• shortness of breath or troubled breathing
• stomach discomfort, upset, or pain
• stuffy or runny nose
• tender, swollen glands in neck
• tightness of chest or wheezing
• trouble in swallowing
• voice changes
• weight changes

Rare

• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• not able to have an orgasm

For healthcare professionals

Applies to selegiline: compounding powder, oral capsule, oral tablet, oral tablet disintegrating, transdermal film extended release.

General

In prospective pre-marketing studies, the most commonly reported side effects leading to treatment discontinuation with selegiline (the active ingredient contained in Carbex) oral tablets were, in decreasing order of frequency, nausea, hallucinations, confusion, depression, loss of balance, insomnia, orthostatic hypotension, increased akinetic involuntary movements, agitation, arrhythmia, bradykinesia, chorea, delusions, hypertension, new or increased angina pectoris, and syncope.

In clinical trials with selegiline orally disintegrating tablets, the most commonly reported side effects leading to treatment discontinuation were dizziness, chest pain, accidental injury, and myasthenia. The relative risk for treatment-emergent hypertension and orthostatic or postural hypotension was reported as being at least 2 fold greater in patients 65 years or older compared to those younger than 65 years. Patients over 65 years were also reported at an increased risk for somnolence compared to younger patients.

In clinical trials with selegiline transdermal patches, application site reaction was reported as the side effect that lead to treatment discontinuation in at least 1% of patients at a rate at least twice that of placebo.

Selegiline potentiates the effects of levodopa; therefore, the side effects of levodopa may be emphasized unless the levodopa dose is reduced.^[Ref]

Psychiatric

• Very common (10% or more): Insomnia
• Common (1% to 10%): Anxiety/tension, confusion, depression, euphoria, hallucinations, illusion, sleeping disorders, vivid dreams
• Uncommon (0.1% to 1%): Abnormal dreams, agitation, manic reaction, mild transient irritability, mood change, psychoses
• Frequency not reported: Apathy, delusions, disorientation, dreams/nightmares, hollow feeling, overstimulation, personality change, sleep disturbance, transient high, transient irritability
• Postmarketing reports: Abnormal thinking, aggressive reaction, bruxism, delirium, impulse control disorders and compulsions, nervousness, paranoid reaction, paroniria, psychotic-like behavior^[Ref]

Insomnia and sleep disorder were reported as very common side effects with selegiline in double-blind placebo-controlled clinical trials at a higher frequency when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease. Insomnia was also reported as a very common side effect in placebo-controlled clinical trials for major depressive disorder with transdermal selegiline.

Parkinson's disease patients treated with dopamine agonists and/or other dopaminergic treatments such as selegiline have been reported as exhibiting impulse control disorders such as pathological gambling, increased libido, hypersexuality, compulsive spending/buying, and binge eating. There have been very few cases reported with selegiline. In some cases, dose reduction or treatment discontinuation led to cessation of impulse control disorders.

Postmarketing reports have indicated that patients taking this drug may experience new or worsening mental status and behavioral changes, such as psychotic-like behavior, particularly after starting therapy or increasing the dose. Certain medications used to treat psychosis (e.g., dopamine antagonists) may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of selegiline. Transient high and bruxism were reported at doses greater than 10 mg per day.

Anxiety was reported as a very common side effect with selegiline in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.

Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.

Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.^[Ref]

Nervous system

• Very common (10% or more): Dizziness/lightheadedness/fainting
• Common (1% to 10%): Abnormal movements (e.g., dyskinesias, bradykinesia, akinesia), ataxia, headache, impaired balance, lethargy, somnolence, syncope, tremor
• Frequency not reported: Chorea, drowsiness, dyskinesia, dystonic symptoms, facial grimace, festination, impaired memory, increased apraxia, involuntary movements, migraine, myoclonic jerks, numbness of toes/fingers, restlessness, speech affected, supraorbital pain, tardive dyskinesia
• Postmarketing reports: Abnormal gait, cerebrovascular disorder, coma, convulsions, hypertonia, involuntary muscle contractions, neuroleptic malignant syndrome, serotonin syndrome, taste disturbance^[Ref]

There have been reports of falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents, in Parkinson's disease patients treated with this drug. These reports have occurred in a setting of pre-existing somnolence.

Impaired memory and myoclonic jerks were reported at doses greater than 10 mg per day. Seizure in dialyzed chronic renal failure in a patient treated with selegiline on concomitant medications has been reported in postmarketing experience.

A symptom complex resembling the neuroleptic malignant syndrome, with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in, antiparkinson therapy.

There have been postmarketing reports of fatal and non-fatal cases of serotonin syndrome with concomitant use of this drug with antidepressants.

Headache was reported as a very common side effect in placebo-controlled clinical trials for major depressive disorder with transdermal selegiline.^[Ref]

Cardiovascular

• Very common (10% or more): Postural hypotension
• Common (1% to 10%): Arrhythmia, bradycardia, chest pain, hypertension, hypotension, edema, palpitations
• Uncommon (0.1% to 1%): Angina pectoris, ankle edema, orthostatic hypotension, supraventricular tachycardia
• Frequency not reported: Peripheral edema, hematoma, tachycardia
• Postmarketing reports: Flushing, myocardial infarction^[Ref]

This drug inhibits the catabolism of dietary amines such as tyramine, and has the potential to produce a hypertensive crisis following the ingestion of tyramine-rich foods or beverages.

Postural hypotension was reported with selegiline (the active ingredient contained in Carbex) in double-blind placebo-controlled clinical trials at a higher frequency when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease compared to the late phase. Palpitation was also reported as a very common side effect in the earlier phases of Parkinson's disease in these trials.^[Ref]

Gastrointestinal

• Very common (10% or more): Dry mouth, irritation of the buccal mucosa (orally disintegrating tablet), mouth ulceration, nausea, stomatitis
• Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, dysphagia, eructation, flatulence, gastric irritation, tooth disorder, vomiting
• Frequency not reported: Gastrointestinal bleeding (exacerbation of pre-existing ulcer disease), heartburn, rectal bleeding, throat burning^[Ref]

Constipation was reported as a very common side effect with selegiline (the active ingredient contained in Carbex) in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.^[Ref]

Other

• Very common (10% or more): Fatigue
• Common (1% to 10%): Fall, pain, vertigo
• Frequency not reported: Chills, generalized ache, falling down, freezing, heavy leg, increased energy, malaise, tinnitus, tiredness, weakness
• Postmarketing reports: Asthenia, death, fever^[Ref]

Increased energy was reported at doses greater than 10 mg per day.

Vertigo was a very common side effect reported with selegiline (the active ingredient contained in Carbex) in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa compared with its use as monotherapy.^[Ref]

Dermatologic

• Very common (10% or more): Rash
• Common (1% to 10%): Ecchymosis, increased sweating, skin disorders
• Uncommon (0.1% to 1%): Hair loss, skin eruptions
• Frequency not reported: Facial hair, photosensitivity^[Ref]

Skin disorders reported with this drug have included skin ulcer, fungal dermatitis, skin hypertrophy, contact dermatitis, herpes simplex, dry skin, sweating, urticaria, and pruritus.^[Ref]

Genitourinary

• Very common (10% or more): Micturition disorder
• Common (1% to 10%): Urinary retention
• Frequency not reported: Hypersexuality, nocturia, penile sensation, prostatic hypertrophy, sexual dysfunction, slow urination, transient anorgasmia, urinary frequency, urinary hesitancy
• Postmarketing reports: Increased libido^[Ref]

Transient anorgasmia and decreased penile sensation were reported at doses greater than 10 mg per day. The estimates of the incidence of untoward sexual experience and performance may also underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue.^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Leucocytopenia, thrombocytopenia^[Ref]

Hepatic

• Common (1% to 10%): ALT/AST increased
• Uncommon (0.1% to 1%): Transient increase in liver enzyme values^[Ref]

Local

• Very common (10% or more): Application site reactions (transdermal patch)^[Ref]

Application site reactions with the transdermal patch were primarily described as erythema and resolved spontaneously with no treatment.^[Ref]

Metabolic

• Very common (10% or more): Anorexia
• Common (1% to 10%): Hypokalemia, weight loss
• Uncommon (0.1% to 1%): Loss of appetite
• Postmarketing reports: Hyperglycemia, hypoglycemia^[Ref]

The 1.25 mg orally disintegrating tablet contains 1.25 mg phenylalanine.

Anorexia was reported as a very common side effect with selegiline in double-blind placebo-controlled clinical trials when used as adjunctive therapy with levodopa in the earlier phases of Parkinson's disease.^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain, leg cramps, leg pain, low back pain, myalgia, musculoskeletal injuries, muscle cramps
• Uncommon (0.1% to 1%): Myopathy
• Frequency not reported: Muscle twitch, stiff neck
• Postmarketing reports: Muscle weakness (myasthenia)^[Ref]

Muscle twitch was reported at doses greater than 10 mg per day.^[Ref]

Ocular

• Common (1% to 10%): Abnormal accommodation
• Uncommon (0.1% to 1%): Blurred vision
• Frequency not reported: Blepharospasm, diplopia
• Postmarketing reports: Abnormal vision^[Ref]

Oncologic

• Frequency not reported: Melanoma^[Ref]

Epidemiological studies have shown that Parkinson's disease patients are at a 2- to 6-fold increased risk of developing melanoma than the general population. It is unclear whether the observed increase in risk is due to Parkinson's disease or other factors.^[Ref]

Renal

• Frequency not reported: Small increments in serum BUN and creatinine^[Ref]

Small increments in serum BUN and creatinine were observed with high doses of orally disintegrating selegiline (10 mg orally per day).^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea, hiccup, nasal congestion, pharyngitis, rhinitis, sinusitis, sore throat
• Frequency not reported: Asthma^[Ref]

Further information

Carbex 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