Pharmagesic Side Effects
Generic name: acetaminophen / butalbital / caffeine
Medically reviewed by Drugs.com. Last updated on Jan 29, 2025.
Note: This document provides detailed information about Pharmagesic Side Effects associated with acetaminophen / butalbital / caffeine. Some dosage forms listed on this page may not apply specifically to the brand name Pharmagesic.
Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Liver failure, sometimes associated with liver transplant or fatalities, has occurred with acetaminophen use.
These cases of liver injury were often associated with the use of more than 1 acetaminophen-based product and with total daily acetaminophen doses exceeding 4000 mg.
Precautions
It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Pharmagesic
Along with its needed effects, acetaminophen/butalbital/caffeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / butalbital / caffeine:
More common side effects
- lightheadedness
- shortness of breath
Incidence not known
- abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blurred vision
- change in the frequency of urination or amount of urine
- chills
- cough
- diarrhea
- difficulty with breathing
- difficulty with swallowing
- dizziness
- drowsiness
- dry mouth
- fainting
- fast, pounding, or irregular heartbeat or pulse
- flushed or dry skin
- fruit-like breath odor
- hives, itching, or skin rash
- increased hunger
- increased thirst
- increased urination
- joint or muscle pain
- loss of appetite
- nausea or vomiting
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- shakiness in the legs, arms, hands, or feet
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sweating
- swelling of the feet or lower legs
- tightness in the chest
- trembling or shaking of the hands or feet
- troubled breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine:
Symptoms of overdose
- confusion as to time, place, or person
- dark urine
- difficult or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- general feeling of discomfort or illness
- hallucinations
- headache
- holding false beliefs that cannot be changed by fact
- increased sweating
- irregular, fast or slow, or shallow breathing
- light-colored stools
- loss of appetite
- pale or blue lips, fingernails, or skin
- restlessness
- sudden decrease in the amount of urine
- sweating
- trouble sleeping
- unpleasant breath odor
- unusual excitement, nervousness, or restlessness
- vomiting of blood
- yellow eyes or skin
Other side effects of Pharmagesic
Some side effects of acetaminophen / butalbital / caffeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- relaxed and calm
- sleepiness
Incidence not known
- anxiety
- bloated
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- depression
- earache
- excess air or gas in the stomach or intestines
- false or unusual sense of well-being
- full feeling
- hearing loss
- heartburn
- heavy eyelids
- high energy
- hot spells
- hyperventilation
- irritability
- numbness
- pain in the leg
- passing gas
- sluggishness
- stuffy nose
- tingling sensation
For healthcare professionals
Applies to acetaminophen / butalbital / caffeine: oral capsule, oral liquid, oral tablet.
General adverse events
The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]
Nervous system
Butalbital/Acetaminophen/Caffeine:
- Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
- Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance
Caffeine:
- Frequency not reported: Tremor[Ref]
Hepatic
Acetaminophen:
- Frequency not reported: Liver failure[Ref]
Acute liver failure has been reported with acetaminophen use; many case have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, vomiting, abdominal pain
- Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]
Renal
Butalbital/Acetaminophen/Caffeine:
- Uncommon (0.1% to 1%): Diuresis
Caffeine:
- Frequency not reported: Nephrotoxicity[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Allergic reactions
- Postmarketing reports: Anaphylaxis
Acetaminophen:
- Postmarketing reports: Anaphylaxis[Ref]
Hematologic
Acetaminophen:
- Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]
Dermatologic
Butalbital/Acetaminophen/Caffeine:
- Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
- Frequency not reported: Toxic epidermal necrolysis, erythema multiforme
Acetaminophen:
- Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
- Frequency not reported: Rash[Ref]
Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.[Ref]
Respiratory
- Common (1% to 10%): Shortness of breath
- Uncommon (0.1% to 1%): Nasal congestion[Ref]
Cardiovascular
Butalbital/Acetaminophen/Caffeine:
- Uncommon (0.1% to 1%): Tachycardia
Caffeine:
- Frequency not reported: Cardiac stimulation[Ref]
Other
- Common (1% to 10%): Intoxicated feeling
- Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus[Ref]
Metabolic
Caffeine:
- Frequency not reported: Hyperglycemia[Ref]
Musculoskeletal
- Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]
Psychiatric
Butalbital/Acetaminophen/Caffeine:
- Uncommon (0.1% to 1%): Agitation, euphoria
Caffeine:
- Frequency not reported: Irritability, dependence[Ref]
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References
1. (2022) "Product Information. Fioricet (acetaminophen / butalbital / caffeine)." Novartis Pharmaceuticals
2. (2016) "Product Information. Acetaminophen/Butalbital/Caffeine (acetaminophen / butalbital / caffeine)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc)
3. (2016) "Product Information. Esgic (acetaminophen / butalbital / caffeine)." Forest Pharmaceuticals
4. (2016) "Product Information. Vanatol LQ (acetaminophen / butalbital / caffeine)." GM Pharmaceuticals
More about Pharmagesic (acetaminophen / butalbital / caffeine)
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- Drug class: analgesic combinations
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Further information
Pharmagesic side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.