Applies to tranylcypromine: oral tablet.
Warning
Oral route (Tablet)
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Tranylcypromine sulfate is not approved for use in pediatric patients.Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine sulfate or after tranylcypromine sulfate discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine sulfate and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.
Serious side effects of Tranylcypromine
Along with its needed effects, tranylcypromine 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 tranylcypromine:
Incidence not known
- Absence of or decrease in body movement
- actions that are out of control
- agitation
- anxiety
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- confusion
- confusion about identity, place, and time
- cough
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- decreased awareness or responsiveness
- depression
- difficulty in passing urine (dribbling)
- dizziness
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- fever with or without chills
- general feeling of tiredness or weakness
- headache
- hoarseness
- hostility
- hyperventilation
- increased need to urinate
- irritability
- light-colored stools
- longer than usual time to ejaculation of semen
- loss of bladder control
- loss of consciousness
- lower back or side pain
- muscle twitching
- nausea
- nervousness
- painful or difficult urination
- pale skin
- passing urine more often
- pinpoint red spots on the skin
- rapid weight gain
- restlessness
- seizures
- severe sleepiness
- shakiness and unsteady walk
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden jerky movements of the body
- swelling of the face, ankles, or hands
- swollen glands
- talking, feeling, and acting with excitement
- trouble with sleeping
- troubled breathing with exertion
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- upper right abdominal pain
- vomiting
- yellow eyes and skin
Other side effects of Tranylcypromine
Some side effects of tranylcypromine 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
- Blurred vision
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased interest in sexual intercourse
- diarrhea
- drowsiness
- dry mouth
- hair loss or thinning of the hair
- hearing loss
- hives or welts, itching, skin rash
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- loss of appetite
- memory loss
- muscle spasm
- redness of the skin
- stomach pain
- unable to sleep
- weakness
- weight loss
For Healthcare Professionals
Applies to tranylcypromine: oral tablet.
General
The most important adverse event is hypertensive crisis, which may be fatal. The most common adverse event is insomnia, which can frequently be overcome by giving the last dose of the day no later than 3 pm or reducing dosage.[Ref]
Cardiovascular
Severe hypertensive reactions have occurred, notably with tyramine containing foods, and are sometimes fatal. Symptoms may include pain and stiffness in the neck, multiple extrasystoles, often with substernal pain, sweating and pallor, sometimes followed by flushing, mydriasis, and photophobia.
Hypotension and postural hypotension were usually temporary, but sometimes required discontinuation of treatment. Blood pressure rapidly returned to pretreatment levels once treatment was stopped.[Ref]
Frequency not reported: Edema, flushing, hypertension, hypertensive crisis, hypotension, multiple extrasystoles, pallor, palpitation, postural hypotension/postural hypotension with syncope, severe hypertensive reaction, substernal pain, tachycardia[Ref]
Nervous system
Frequency not reported: Adverse effects on the ability to drive and operate machinery, akathisia, drowsiness, dizziness, dysgeusia, headache, headache without blood pressure elevation, hyperreflexia, lethargy, myoclonic jerks, numbness, nystagmus, paresthesia, sedation, seizures, serotonin syndrome, syncope, throbbing headache, tremor, unusually frequent headaches
Postmarketing reports: Akinesia, ataxia, memory loss[Ref]
Psychiatric
Frequency not reported: Aggravation of coexisting symptoms of depression, agitation, anxiety, discontinuation syndrome, drug dependence, excessive stimulation, hallucinations, hypomania, insomnia, loss of libido, mania, manic symptoms, overexcitement, overstimulation, restlessness, sleep disturbances, suicidal behavior, suicidal ideation/thoughts, withdrawal symptoms
Postmarketing reports: Confusion, disorientation[Ref]
Drug dependence with tolerance to high doses may occur in patients without a history of drug dependence.
Overstimulation included increased anxiety, agitation, and manic symptoms, and was usually a sign of excessive therapeutic action.[Ref]
Gastrointestinal
Frequency not reported: Abdominal pain, constipation, diarrhea, dry mouth, nausea, vomiting
Postmarketing reports: Fissuring in corner of mouth[Ref]
Endocrine
Frequency not reported: Syndrome of inappropriate antidiuretic syndrome (SIADH)[Ref]
Genitourinary
Frequency not reported: Delayed ejaculation, impotence, retarded ejaculation, urinary retention
Postmarketing reports: Urinary frequency, urinary incontinence[Ref]
Hematologic
Frequency not reported: Agranulocytosis, anemia, blood dyscrasias, leukopenia, thrombocytopenia[Ref]
Hepatic
Frequency not reported: Elevated aminotransferases, hepatitis, hepatocellular damage, hepatotoxicity, jaundice[Ref]
Musculoskeletal
Frequency not reported: Muscle spasm, neck stiffness
Postmarketing reports: Localized scleroderma[Ref]
Other
Frequency not reported: Chills, drug tolerance, excessive therapeutic action, fatigue, pain, persistence of MAO inhibition after discontinuation, tinnitus, weakness[Ref]
Ocular
Frequency not reported: Blurred vision, mydriasis, photophobia[Ref]
Dermatologic
Frequency not reported: Alopecia, skin rash/rash, sweating
Postmarketing reports: Flare up of cystic acne, urticaria[Ref]
Metabolic
Frequency not reported: Hypoglycemia, impaired water excretion, significant anorexia, weight gain[Ref]
