P-A-C Analgesic Side Effects
Generic Name: aspirin / caffeine
Note: This document contains side effect information about aspirin / caffeine. Some of the dosage forms listed on this page may not apply to the brand name P-A-C Analgesic.
For the Consumer
Applies to aspirin / caffeine: oral tablet
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: 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 bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Feeling confused.
- Very bad dizziness or passing out.
- Very bad headache.
- Ringing in ears.
- Hearing loss.
- Very bad belly pain.
- A fast heartbeat.
- Very nervous and excitable.
What are some other side effects of this drug?
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 nervous and excitable.
- Not able to sleep.
- Belly pain or heartburn.
- Upset stomach or throwing up.
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.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
The more commonly reported adverse events with aspirin have included gastrointestinal events such as nausea and dyspepsia; caffeine may cause nervousness, irritability, sleeplessness, and palpitations, especially with higher doses.[Ref]
Very Common (10% or more): Epigastric distress (up to 83%)
Common (1% to 10%): Abdominal discomfort/pain, endoscopically identifiable gastric mucosal lesions, nausea, vomiting
Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin-containing rectal suppositories.[Ref]
Frequency not reported: Predictable antiplatelet effects, hemorrhage, increased blood fibrinolytic activity, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, pancytopenia, aplastic anemia, ecchymosis
Very common (10% or more): Hypersensitivity reactions in asthmatics who are aspirin-sensitive (e.g., with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps)
Frequency not reported: Bronchospasm (in patients sensitive to aspirin and other NSAID)
The mechanism of an aspirin-induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.
Frequency not reported: Renal dysfunction, renal failure, increased blood uric acid levels
Frequency not reported: Reye's syndrome, tinnitus, temporary hearing loss
Frequency not reported: Fibrocystic breast disease
In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds
Frequency not reported: Stevens-Johnson syndrome, lichenoid eruption
Frequency not reported: Hepatotoxicity, cholestatic hepatitis, aminotransferase elevations
Frequency not reported: Nervousness, irritability, sleeplessness (particularly in higher doses)
Frequency not reported: Dizziness, headache
Frequency not reported: Dizziness, tremor
Frequency not reported: Palpitations
Frequency not reported: Interstitial nephritis, papillary necrosis, proteinuria
1. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Multum Information Services, Inc. Expert Review Panel"
Some side effects may not be reported. You may report them to the FDA.