Zebutal Side Effects

Generic Name: acetaminophen / butalbital / caffeine

Note: This page contains side effects data for the generic drug acetaminophen / butalbital / caffeine. It is possible that some of the dosage forms included below may not apply to the brand name Zebutal.

It is possible that some side effects of Zebutal may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet

As well as its needed effects, acetaminophen / butalbital / caffeine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking acetaminophen / butalbital / caffeine, check with your doctor immediately:

More common
  • 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 heartbeat
  • fast, pounding, or irregular heartbeat or pulse
  • flushed or dry skin
  • fruit-like breath odor
  • hives
  • increased hunger
  • increased thirst
  • increased urination
  • itching
  • 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
  • seizure
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • 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
  • wheezing

If any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine, get emergency help immediately:

Symptoms of overdose
  • Confusion as to time, place, or person
  • dark urine
  • difficult or painful urination
  • difficult or troubled breathing
  • 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
  • sleeplessness
  • sudden decrease in the amount of urine
  • sweating
  • trouble sleeping
  • unable to sleep
  • unpleasant breath odor
  • unusual excitement, nervousness, or restlessness
  • vomiting of blood
  • yellow eyes or skin

Some acetaminophen / butalbital / caffeine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • 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

Nervous system

Nervous system side effects including drowsiness, lightheadedness, dizziness, sedation, and an intoxicated feeling have been reported frequently from the use of butalbital. Headache and seizures have been reported infrequently. Mental confusion, excitement, or depression have also been reported due to either intolerance (primarily in elderly or debilitated patients) or due to an overdose of butalbital.

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate PMS.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting.

Gastrointestinal

Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose. Nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital. In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Renal

Renal side effects are rare with acetaminophen and include acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects including acetaminophen associated bullous erythema and purpura fulminans have been reported. Erythematous skin rashes associated with acetaminophen have been reported rarely. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Respiratory

Respiratory side effects including dyspnea have been reported frequently with the use of butalbital. A case of acetaminophen-induced eosinophilic pneumonia has also been reported.

Cardiovascular

Cardiovascular side effects including several cases of hypotension have been reported following the administration of acetaminophen.

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.

Other

Other side effects have included a positive association with 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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