Last reviewed · How we verify
Zoloft
At a glance
| Generic name | Zoloft |
|---|---|
| Sponsor | Katarina Wide |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior 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 [See Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Antidepressants increased the risk of suicidal thoughts
Common side effects
- Nausea
- Insomnia
- Diarrhea/Loose stools
- Dry mouth
- Fatigue
- Dizziness
- Somnolence
- Tremor
- Dyspepsia
- Agitation
- Ejaculation failure
- Decreased appetite
Serious adverse events
- Male sexual dysfunction
- Discontinuation due to adverse reaction
Key clinical trials
- TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children (PHASE4)
- Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan (NA)
- ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression (PHASE2)
- Pattern Separation in Major Depressive Disorder (PHASE1)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Predicting SSRI Efficacy in Veterans With PTSD (PHASE4)
- Sertraline and the Risk of Serious Adverse Events
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, 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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |