ADVERSE REACTIONS
ADVERSE REACTIONS
Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
| ||
Gastrointestinal (GI) experiences including: | ||
abdominal pain | constipation/diarrhea | dyspepsia |
flatulence | GI fullness | GI ulcers (gastric/duodenal) |
gross bleeding/perforation | heartburn | nausea* |
stomatitis | vomiting |
|
Other experiences: | ||
abnormal renal function | anemia | dizziness |
drowsiness | edema | elevated liver enzymes |
headaches* | hypertension | increased bleeding time |
injection site pain | pruritus | purpura |
rashes | tinnitus | sweating |
Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include:
Body as a Whole: fever, infections, sepsis
Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope
Dermatologic: alopecia, photosensitivity, urticaria
Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding
Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia
Metabolic and Nutritional: weight change
Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise
Reproductive, female: infertility
Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis
Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss
Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention
Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine or other NSAIDs) are:
Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS), myalgia
Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis
Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption (FDE)
Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, post operative wound hemorrhage (rarely requiring blood transfusion — see Boxed WARNING, WARNINGS, and PRECAUTIONS)
Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia
Nervous System: aseptic meningitis, convulsions, coma, psychosis
Respiratory: bronchospasm, respiratory depression, pneumonia
Special Senses: conjunctivitis
Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome
Postmarketing Surveillance Study
A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamine, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent (see Tables 3A and 3B). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine (see Table 3A).
A. Adult Patients without History of PUB | ||||
Age of Patients | Total Daily Dose of Ketorolac Tromethamine Injection | |||
≤60 mg | >60 to 90 mg | >90 to 120 mg | >120 mg | |
<65 years of age | 0.4% | 0.4% | 0.9% | 4.6% |
≥65 years of age | 1.2% | 2.8% | 2.2% | 7.7% |
B. Adult Patients with History of PUB | ||||
Age of Patients | Total Daily Dose of Ketorolac Tromethamine Injection | |||
≤60 mg | >60 to 90 mg | >90 to 120 mg | >120 mg | |
<65 years of age | 2.1% | 4.6% | 7.8% | 15.4% |
≥65 years of age | 4.7% | 3.7% | 2.8% | 25.0% |
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
- •
- Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
- •
- with increasing doses of NSAIDs
- •
- with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
- •
- Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
- •
- anytime during use
- •
- without warning symptoms
- •
- that may cause death
The risk of getting an ulcer or bleeding increases with:
• past history of stomach ulcers, • increasing doses of NSAIDs
or stomach or intestinal • longer use of NSAIDs
bleeding with the use of • smoking
NSAIDs • drinking alcohol
• taking medicines called • older age
"corticosteroids", • poor health
"anticoagulants", "SSRIs", or • advanced liver disease
"SNRIs" • bleeding problems
NSAIDs should only be used:
- •
- exactly as prescribed
- •
- at the lowest dose possible for your treatment
- •
- for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
- •
- if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
- •
- right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
- •
- have liver or kidney problems
- •
- have high blood pressure
- •
- have asthma
- •
- are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
- •
- are breastfeeding or plan to breast feed
Tell your healthcare provider about all of the medicines you take, including prescription or over‑the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including:
- •
- new or worse high blood pressure
- •
- heart failure
- •
- liver problems including liver failure
- •
- kidney problems including kidney failure
- •
- low red blood cells (anemia)
- •
- life-threatening skin reactions
- •
- life-threatening allergic reactions
- •
- Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms:
- •
- shortness of breath or trouble breathing
- •
- chest pain
- •
- weakness in one part or side of your body
- •
- slurred speech
- •
- swelling of the face or throat
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
• nausea • vomit blood
• more tired or weaker than usual • there is blood in your bowel movement
• diarrhea or it is black and sticky like tar
• itching • unusual weight gain
• your skin or eyes look yellow • skin rash or blisters with fever
• indigestion or stomach pain • swelling of the arms and legs, hands and
• flu-like symptoms feet
If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Other information about NSAIDs
- •
- Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
- •
- Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 
LAB-0895-5.0
Revised: 06/2024
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