Last reviewed · How we verify
PHENELZINE SULFATE
At a glance
| Generic name | PHENELZINE SULFATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1961 |
Approved indications
Boxed warnings
- Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Phenelzine Sulfate Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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. Phenelzine Sulfate Tablets is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
Common side effects
- Dizziness
- Headache
- Drowsiness
- Sleep disturbances
- Insomnia
- Hypersomnia
- Fatigue
- Weakness
- Tremors
- Twitching
- Myoclonic movements
- Hyperreflexia
Serious adverse events
- Hypermetabolic syndrome
- Fatal progressive necrotizing hepatocellular damage
- Manic reaction
- Convulsions
- Toxic delirium
- Shock-like coma
- Precipitation of schizophrenia
- Edema of the glottis
- Lupus-like syndrome
- Leukopenia
Key clinical trials
- Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer (PHASE2)
- A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure (PHASE1)
- An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer (PHASE1)
- Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PHENELZINE SULFATE CI brief — competitive landscape report
- PHENELZINE SULFATE updates RSS · CI watch RSS