URL of this page: https://medlineplus.gov/druginfo/meds/a693001.html

Ketorolac

pronounced as (kee toe role' ak)

Notice:

[Posted 10/15/2020]

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.

For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.

For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: http://bit.ly/2Uadlbz. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.

BACKGROUND:

NSAIDs

  • are a class of medicines available by prescription and OTC. They are some of the most commonly used medicines for pain and fever.
  • are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.
  • work by blocking the production of certain chemicals in the body that cause inflammation.
  • are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.

Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

RECOMMENDATION:

Consumers/Patients

  • If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.
  • Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels, available at: http://bit.ly/2Uadlbz, to find out if the medicines contain NSAIDs.
  • Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.
  • Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.

Health Care Professionals

  • FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
  • These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
  • Oligohydramnios is often, but not always, reversible with treatment discontinuation.
  • Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
  • If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.
  • The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.
  • Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

IMPORTANT WARNING:

Ketorolac is used for the short-term relief of moderately severe pain and should not be used for longer than 5 days, for mild pain, or for pain from chronic (long-term) conditions. You will receive your first doses of ketorolac by intravenous (into a vein) or intramuscular (into a muscle) injection in a hospital or medical office. After that, your doctor may choose to continue your treatment with oral ketorolac. You must stop taking oral ketorolac on the fifth day after you received your first ketorolac injection. Talk to your doctor if you still have pain after 5 days or if your pain is not controlled with this medication. Ketorolac may cause serious side effects, especially when taken improperly. Take ketorolac exactly as directed. Do not take more of it or take it more often than prescribed by your doctor.

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ketorolac may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as ketorolac if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke or 'ministroke;' if you smoke; and if you have or have ever had high cholesterol, high blood pressure, bleeding or clotting problems, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketorolac. If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ketorolac right before or right after the surgery.

NSAIDs such as ketorolac may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking ketorolac. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Do not take aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) while you are taking ketorolac. Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines. If you experience any of the following symptoms, stop taking ketorolac and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Ketorolac may cause kidney failure. Tell your doctor if you have kidney or liver disease, if you have had severe vomiting or diarrhea or think you may be dehydrated, and if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); or diuretics ('water pills'). If you experience any of the following symptoms, stop taking ketorolac and call your doctor: swelling of the hands, arms, feet, ankles, or lower legs; unexplained weight gain; confusion; or seizures.

Some people have severe allergic reactions to ketorolac. Tell your doctor if you are allergic to ketorolac, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn), or any other medications. Also tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose). If you experience any of the following symptoms, stop taking ketorolac and call your doctor right away: rash; hives; itching; swelling of the eyes, face, throat, tongue, arms, hands, ankles, or lower legs; difficulty breathing or swallowing; or hoarseness.

Do not breastfeed while you are taking ketorolac.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ketorolac. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ketorolac and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Why is this medication prescribed?

Ketorolac is used to relieve moderately severe pain, usually after surgery. Ketorolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

How should this medicine be used?

Ketorolac comes as a tablet to take by mouth. It is usually taken every 4 to 6 hours on a schedule or as needed for pain. If you are taking ketorolac on a schedule, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking ketorolac,

  • tell your doctor if you are taking pentoxifylline (Pentoxil) or probenecid (Probalan, in Col-Probenecid). Your doctor will probably tell you not to take ketorolac if you are taking one or more of these medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants; angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran); medications for anxiety or mental illness; medications for seizures such as carbamazepine (Epitol, Tegretol, Teril, others) or phenytoin (Dilantin, Phenytek); methotrexate (Otrexup, Rasuvo, Trexall); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
  • tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or heart failure or swelling of the hands, feet, ankles, or lower legs.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or you plan to become pregnant. If you become pregnant while taking ketorolac, call your doctor.
  • talk to your doctor about the risks and benefits of taking ketorolac if you are 65 years of age or older. Older adults should not usually take ketorolac because it is not as safe as other medications that can be used to treat the same condition.
  • you should know that this medication may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
  • talk to your doctor about the safe use of alcohol while taking this medication. Alcohol can make the side effects of ketorolac worse.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If your doctor has told you to take ketorolac regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Ketorolac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • dizziness
  • drowsiness
  • diarrhea
  • constipation
  • gas
  • sores in the mouth
  • sweating

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ketorolac until you speak to your doctor.

  • fever
  • blisters
  • unexplained weight gain
  • shortness of breath or difficulty breathing
  • swelling in the abdomen, ankles, feet, or legs
  • yellowing of the skin or eyes
  • excessive tiredness
  • unusual bleeding or bruising
  • lack of energy
  • nausea
  • loss of appetite
  • pain in the upper right part of the stomach
  • flu-like symptoms
  • pale skin
  • fast heartbeat
  • cloudy, discolored, or bloody urine
  • back pain
  • difficult or painful urination

Ketorolac may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • nausea
  • vomiting
  • stomach pain
  • bloody, black, or tarry stools
  • vomit that is bloody or looks like coffee grounds
  • drowsiness
  • slowed breathing or fast, shallow breathing
  • coma (loss of consciousness for a period of time)

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Toradol®

This branded product is no longer on the market. Generic alternatives may be available.

Last Revised - 11/15/2020