Toradol

(Generic versions may still be available.)

DRUG DESCRIPTION

TORADOL (ketorolac tromethamine) is a member of the pyrrolo-pyrrole group of
nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac
tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic
acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the
chemical structure is:

Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine.
Ketorolac tromethamine may exist in three crystal forms. All forms are equally
soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water
partition coefficient of 0.26. The molecular weight of ketorolac tromethamine
is 376.41. Its molecular formula is C₁₉H₂₄N₂O₆.

TORADOL (ketorolac tromethamine) ^ORAL is available as round, white, film-coated, red-printed
tablets. Each tablet contains 10 mg ketorolac tromethamine, the active ingredient,
with added lactose, magnesium stearate and microcrystalline cellulose. The white
film-coating contains hydroxypropyl methylcellulose, polyethylene glycol and
titanium dioxide.

The tablets are printed with red ink that includes FD&C Red #40 Aluminum
Lake as the colorant. There is a large T printed on both sides of the tablet,
as well as the word TORADOL (ketorolac tromethamine) on one side, and the word ROCHE on the other.

What are the possible side effects of ketorolac (Toradol, Toradol IM, Toradol IV/IM)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ketorolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;


• black, bloody, or tarry stools;


• coughing up blood or vomit that looks like coffee grounds;

...

Read All Potential Side Effects and See Pictures of Toradol »

What are the precautions when taking ketorolac tromethamine (Toradol)?

Before taking ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, growths in the nose (nasal polyps),...

Read All Potential Precautions of Toradol »

Toradol Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, unusual tiredness, nausea, vomiting, constipation, diarrhea, gas, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), mental/mood changes (such as confusion, depression), persistent/severe headache, stomach pain, sudden/unexplained weight gain, swelling of the hands or feet, vision changes (such as blurred vision).

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, change in amount of urine, signs of infection (such as fever, chills, persistent sore throat), symptoms of meningitis (such as unexplained stiff neck, fever).

This drug may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, growths in the nose (nasal polyps), throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers), stroke, swelling of the ankles/feet/hands, a severe loss of body water (dehydration).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may cause stomach/intestinal bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may infrequently make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of the drug, especially bleeding in the stomach/intestines or effects on the kidneys. Using high doses for a long time may increase this risk.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in very small amounts and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Toradol Patient Information Including Side Effects

Brand Names: Toradol, Toradol IM, Toradol IV/IM

Generic Name: ketorolac (Pronunciation: KEE toe ROLE ak)

• What is ketorolac (Toradol)?


• What are the possible side effects of ketorolac (Toradol)?


• What is the most important information I should know about ketorolac (Toradol)?


• What should I discuss with my healthcare provider before taking ketorolac (Toradol)?


• How should I take ketorolac (Toradol)?


• What happens if I miss a dose (Toradol)?


• What happens if I overdose (Toradol)?


• What should I avoid while taking ketorolac (Toradol)?


• What other drugs will affect ketorolac (Toradol)?


• Where can I get more information?

What is ketorolac (Toradol)?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Ketorolac is used short-term (5 days or less) to treat moderate to severe pain.

Ketorolac may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ketorolac (Toradol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ketorolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;


• black, bloody, or tarry stools;


• coughing up blood or vomit that looks like coffee grounds;


• swelling or rapid weight gain;


• urinating less than usual or not at all;


• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);


• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;


• the first sign of any mouth sores or skin rash, no matter how mild;


• pale skin, easy bruising, severe tingling, numbness, pain, muscle weakness; or


• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

• upset stomach, mild nausea or vomiting, diarrhea, constipation;


• mild heartburn, stomach pain, bloating, gas;


• dizziness, headache, drowsiness;


• sweating; or


• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ketorolac (Toradol)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use ketorolac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ketorolac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking ketorolac. Alcohol can increase the risk of stomach bleeding caused by ketorolac.

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