Zoloft (sertraline hydrochloride)


Sertraline Hydrochloride Tablets, For oral use.



Selective Serotonin Reuptake Inhibitor (SSRI) for the off label use of treating Premature Ejaculation (PE) (1).
Tablets: 25mg, 50mg, 100mg, 200mg
Please note that while the maximum dose of Sertraline is 200mg per day, you will need to follow the directions on your patient label. Your dosage is individualized based on other prescription medications, over the counter medications, herbal supplements, and vitamins that you are taking. It is also important to let your doctor know about all the medications you are taking (prescription, OTC, and vitamins) and if you have any liver impairment as this may alter your dosing.
  • It is used to treat low mood (depression).
  • It is used to treat obsessive-compulsive problems.
  • It is used to treat panic attacks.
  • It is used to treat post-traumatic stress.
  • It is used to treat mood problems caused by monthly periods.
  • It is used to treat social anxiety problems. 
Store in a cool, dry place that is free from any moisture at room temperature. Keep all drugs in a safe place, away from children and pets. Throw away any expired or unused drugs, do not flush down the toilet or put down a sink unless told to do so. Check with your pharmacist if you have questions about the best way to dispose of drugs.
When taken for erectile dysfunction, Sertraline becomes most effective after 2-4 weeks of daily intake and lasts 24-36 hours. If taken when needed, Sertraline will work about 4-6 hours after being taken.
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drugs affects you.
  • Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
  • Avoid drinking alcohol while taking this drug.
  • Talk with your doctor before you use marijuana, other forms of cannabis, or prescription or OTC drugs that may slow your actions.
  • In depression, sleep and appetite may get better soon after starting this drug. Other low mood signs may take up to 4 weeks to get better.
  • This drug may raise the chance of a broken bone. Talk with the doctor.
  • This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
  • This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death.
  • Some people may have a higher chance of eye problems with this drug. Your doctor may want you have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
  • A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child. 
  • Please follow the directions on your patient label. This medication is an oral medication only and should not be split, crushed, or chewed.
  • Sertraline for P.E. should be taken daily for best results, but can also be taken 4-6 hours before sexual activity.
  • This medication can be taken with or without food, however please be aware that if you consume a high fat meal, the medication will take longer to start working.
  • Do not take this medication if you are allergic to this drug, or any part of this drug.
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Grapefruit. Avoid grapefruit/grapefruit juice while taking this medication.


All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling dizzy, sleepy, tired, or weak
  • Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry
  • Dry mouth
  • Trouble sleeping
  • Sweating a lot
  • Shakiness

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.



Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
  • Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Seizures.
  • Not able to control bladder.
  • A big weight gain or loss.
  • Sex problems have happened with drugs like this one. This includes lowered interest in sex,
  • trouble having an orgasm, ejaculation problems, or trouble getting or keeping an erection. If you have any sex problems or if you have any questions, talk with your doctor.
  • Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A type of abnormal heartbeat (prolonged QT interval) has happened with this drug. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out.
  • These are not all of the severe side effects that may occur. 

Your safety as our patient is our highest priority. Please be sure to inform your primary care physician and your pharmacist that you are taking this medication. It is helpful to keep an updated list of all the prescription medications, over the counter medications, herbal supplements, and vitamins you are currently taking. This will help all of your healthcare providers ensure none of your medications will interact or cause harmful side effects. Read this medication guide with care, read it again each time this medication is refilled. If you have any questions about this medication, please contact your doctor, pharmacist, or other healthcare provider.

If you require additional consultation, a pharmacist can be reached at 1-310-800-2265 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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