... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-FAQ | Instructions | Glossary | Contact Us Search Results for 'sertraline ' Products listed on this page may not be equivalent to one another. Click on a drug name for more information: Click on a column header to re-sort the table: Drug Name Active Ingredients SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE ZOLOFT SERTRALINE HYDROCHLORIDE Back to Top | Back to Previous Page | Back to Drugs @FDA Home Disclaimer FDA / Center for Drug Evaluation and Research Office of Training and Communications Division of Information Services Update Frequency: Daily---Home About FDA Contact Us A to Z Subject Index Web Site Policies FOIA Accessibility No FEAR Act Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections / Compliance State & Local Officials Consumers Industry Health Professionals-- ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prescribing Information-- Zoloft (sertraline HCl) Tablets and Oral Concentrate January 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS Serotonin Syndrome or Neuroleptic Malignant Syndrome ...

... Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Drugs Home >Drugs >Drug Safety and Availability >Postmarket Drug Safety Information for Patients and Providers Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Drug Safety Information for Healthcare Professionals Public Health Advisories (Drugs) 2009 Public Health Advisories 2008 Public Health Advisories 2007 Public Health Advisories 2006 Public Health Advisories 2005 Public Health Advisories 2004 Public Health Advisories 2003 Public Health Advisories 2002 Public Health Advisory 2001 Public Health Advisories 2000 Public Health Advisories Pre-2000 Public Health Advisories-Sertraline (marketed as Zoloft) Information Sertraline (marketed as Zoloft) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). This class of drugs is used to treat depression, anxiety, and other mood disorders. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, using the contact information at the bottom of this page.-Related Information Antidepressant Use in Children, Adolescents, and Adults 5 / 2 / 2007 Information for Healthcare ...

... Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products 2010 Safety Alerts for Human Medical Products 2009 Safety Alerts for Human Medical Products 2008 Safety Alerts for Human Medical Products 2007 Safety Alerts for Human Medical Products 2006 Safety Alerts for Human Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Zoloft (sertraline hydrochloride) Audience: Psychiatrists and other healthcare professionals At the request of the FDA, Pfizer issued an important drug warning letter announcing that they have added new information to the CONTRAINDICATIONS and PRECAUTIONS sections of the Zoloft labeling, contraindicating the concomitant use of pimozide with sertraline. [November 2002-Letter-Pfizer]-- Links on this page: Page Last Updated: 07 / 09 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About FDA Contact Us ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Zoloft (sertraline hydrochloride) Prescribing Informatiom March 2008-- Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-March 2008 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified PRECAUTIONS Abnormal Bleeding Information for Patients Drug Interactions Drugs That Interfere With Hemostasis (Non-selective NSAIDs, ...

... Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products 2010 Safety Alerts for Human Medical Products 2009 Safety Alerts for Human Medical Products 2008 Safety Alerts for Human Medical Products 2007 Safety Alerts for Human Medical Products 2006 Safety Alerts for Human Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Zoloft (sertraline) Audience: Neuropsychiatric healthcare professionals and consumers [UPDATE 07 / 08 / 2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. [Posted 07 / 01 / 2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has ...

... ) â €¢ Paxil (paroxetine HCl) â €¢ Pexeva (paroxetine mesylate) â €¢ Prozac (fluoxetine HCl) â €¢ Remeron (mirtazapine) â €¢ Sarafem (fluoxetine HCl) â €¢ Seroquel (quetiapine) â €¢ Sinequan (doxepin) â €¢ Surmontil (trimipramine) â €¢ Symbyax (olanzapine / fluoxetine) â €¢ Tofranil (imipramine) â €¢ Tofranil-PM (imipramine pamoate) â €¢ Triavil (perphenazine / amitriptyline) â €¢ Vivactil (protriptyline) â €¢ Wellbutrin (bupropion HCl) â €¢ Zoloft (sertraline HCl) â €¢ Zyban (bupropion HCl) Additional Information: FDA MedWatch Safety Alert. Antidepressant Medication Products. May 2, 2007. http :// www.fda.gov / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProduct / ucm153362.htm FDA Patient Safety News is available at www.fda.gov / psn ...

... Important Warnings in Antidepressant Drug Labeling FDA Patient Safety News: Show #31, September 2004 Now an update on several important changes to the labeling of antidepressant drugs. The first changes address suicide risk and clinical worsening of depression, a topic we've talked about before on this program. We told you that FDA was working with antidepressant drug manufacturers to add new warnings to their drugs ' labels. The drugs that are the focus of these changes are: Prozac (fluoxetine ), Zoloft (sertraline ), Paxil (paroxetine ), Luvox (fluvoxamine ), Celexa (citalopram ), Lexapro (escitalopram ), Wellbutrin (bupropion ), Effexor (venlafaxine ), Serzone (nefazodone ), and Remeron (mirtazapine). A number of the manufacturers have already changed the labeling for their drugs, and have notified health care professionals about the changes. The new labeling says that both adult and pediatric patients with major depressive disorder may experience a worsening of their depression or start to have suicidal thoughts, and that this can happen whether or not they're taking antidepressant drugs. Even though a causal link hasn't been ...

... , May 2004 In a previous edition of FDA Patient Safety News, we told you about FDA's ongoing review of a possible increased risk of suicidal thinking and suicide attempts in pediatric patients being treated with various antidepressants. Although this review is still underway, FDA has now sent a new advisory to health care professionals. The advisory describes new warnings about the need to closely observe both children and adults on antidepressants. The trade names of the drugs that are the focus of this labeling change include: Prozac (fluoxetine ); Zoloft (sertraline ); Paxil (paroxetine ); Luvox (fluvoxamine ); Celexa (citalopram ); Lexapro (escitalopram ); Wellbutrin (bupropion ); Effexor (venlafaxine ); Serzone (nefazodone ); and, Remeron (mirtazapine). The advisory says to carefully monitor patients on these drugs for possible worsening depression or emergent suicidality. This is especially important at the beginning of treatment or when the dose is either increased or decreased. At this point, a causal link hasn't been established between these drugs and suicidality. Suicidal thoughts and attempts in these patients might be due to ...

... Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Drugs Home >Drugs >Drug Safety and Availability >Postmarket Drug Safety Information for Patients and Providers Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-Historical Information on Sertraline hydrochloride (marketed as Zoloft) These items are out-of-date. For current information on sertraline hydrochloride, see Sertraline (marketed as Zoloft) Information. Previous FDA Alert: Suicidal Thoughts or Actions in Children and Adults [issued 7 / 2005] 7 / 2006 update: The issues described below have been addressed in product labeling. All patients being treated with any type of antidepressants should be observed closely for clinical worsening and suicidality especially during the first few months of therapy and when the dose is modified. Pediatrics FDA has concluded that suicidal ...