ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the
treatment of (1):
? Major depressive disorder (MDD)
? Obsessive-compulsive disorder (OCD)
? Panic disorder (PD)
? Post-traumatic stress disorder (PTSD)
? Social anxiety disorder (SAD)
? Premenstrual dysphoric disorder (PMDD)
Take ZOLOFT exactly as prescribed. Your healthcare provider may need to change the dose of ZOLOFT until
it is the right dose for you.
? ZOLOFT Tablets may be taken with or without food.
? ZOLOFT Oral Solution may look cloudy or hazy after mixing, this is normal.
? ZOLOFT Oral Solution must be diluted before use:
oDo not mix ZOLOFT until you are ready to take it.
oWhen diluting ZOLOFT Oral Solution, use only water, ginger ale, lemon/lime soda, lemonade, or orange
oThe oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or
pharmacist about the best way to measure your medicine.
? If you miss a dose of ZOLOFT, take the missed dose as soon as you remember. If it is almost time for the next
dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ZOLOFT at
the same time.
If you take too much ZOLOFT, call your healthcare provider or poison control center right away, or go to
the nearest hospital emergency room right away.
The most common side effects in adults who take ZOLOFT include:
? nausea, loss of appetite, diarrhea, or
? change in sleep habits including increased sleepiness or insomnia
? increased sweating ? sexual problems including decreased libido and ejaculation failure
? tremor or shaking ? feeling tired or fatigued
? agitation ? anxiety
The most common side effects in children and adolescents who take include abnormal increase in muscle
movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and
weight change. Your child’s height and weight should be monitored during treatment with ZOLOFT.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are
not all the possible side effects of ZOLOFT. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088
Store ZOLOFT at room temperature, 68 °F to 77°F (20°C to 25°C).
? Keep ZOLOFT bottle closed tightly.
Keep ZOLOFT and all medicines out of the reach of children.
Protein-bound drugs: Monitor for adverse reactions and reduce dosage of
ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. (7.1,
? CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1,
The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting,
tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been
Other important adverse events reported with ZOLOFT overdose (single or multiple drugs) include bradycardia,
bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction,
pancreatitis, QT-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope.
No specific antidotes for ZOLOFT are known. Contact Poison Control (1-800-222-1222) for latest