Acetaminophen / butalbital / caffeine / codeine Side Effects
Not all side effects for acetaminophen / butalbital / caffeine / codeine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule
In addition to its needed effects, some unwanted effects may be caused by acetaminophen / butalbital / caffeine / codeine. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / butalbital / caffeine / codeine:Less common
- Confusion (mild)
- mental depression
- unusual excitement (mild)
- Bleeding or crusting sores on the lips
- chest pain
- fever with or without chills
- hallucinations (seeing, hearing, or feeling things that are not there)
- hive-like swellings on the eyelids, face, lips, or tongue
- muscle cramps or pain
- red, thickened, or scaly skin
- skin rash
- sores, ulcers, or white spots in the mouth
- sore throat
- swollen or painful glands
- tightness in the chest
- troubled breathing
If any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine / codeine, get emergency help immediately:Symptoms of overdose
- Anxiety (severe)
- cold and clammy skin
- confusion (severe)
- convulsions (seizures)
- dizziness, lightheadedness, drowsiness, or weakness (severe)
- excitement (severe)
- increased sleepiness in babies (more than usual)
- increased sweating
- irritability (severe)
- limpness (in babies)
- nausea or vomiting
- restlessness (severe)
- shortness of breath or unusually slow or troubled breathing
- slow, fast, or irregular heartbeat
- slurred speech
- stomach cramps or pain
- swelling, pain, or tenderness in the upper abdomen or stomach area
- trembling or shaking of the hands or feet
- trouble sleeping (severe)
Some of the side effects that can occur with acetaminophen / butalbital / caffeine / codeine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Bloated or "gassy" feeling
- dizziness or lightheadedness (mild)
- drowsiness (mild)
- stomach pain (mild)
For Healthcare Professionals
Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule
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.
Acetaminophen is generally well tolerated when administered in therapeutic doses.[Ref]
In alcoholic patients, severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen. Hepatotoxicity has been increased during fasting.[Ref]
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.[Ref]
In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.
Nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital.
Nausea, vomiting, and constipation are relatively common. Severe constipation and ileus resulting in colonic perforation have been also reported. Four cases of acute pancreatitis have been reported.
Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose.[Ref]
Renal side effects are rare with acetaminophen use 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 renal failure (which may respond to naloxone therapy) has been reported in association with codeine therapy.[Ref]
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.[Ref]
Hypersensitivity reactions, including anaphylaxis and fixed drug eruptions, have been reported rarely in association with acetaminophen use.[Ref]
Rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]
Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). Erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported.
Codeine-induced rashes have been reported rarely. Codeine-induced rashes may be related to direct stimulation of histamine release. Case reports of severe scarlatiniform eruptions have also been reported.[Ref]
Dyspnea has been reported frequently with the use of butalbital.
A case of acetaminophen-induced eosinophilic pneumonia has been reported.[Ref]
At least two cases of hypotension have been reported following the administration of acetaminophen.
Cardiovascular adverse effects of codeine include hypotension and dizziness.[Ref]
Two cases of 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.
Hypotension is rare with codeine use and has been reported most frequently with high doses.[Ref]
Central nervous system adverse effects reported from the use of codeine include mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has been associated with codeine therapy, particularly in the elderly.
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.[Ref]
Opioids may result in psychotic symptoms in some patients.
One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched nonusers.[Ref]
Withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics may occur and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating.
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.[Ref]
Urinary retention has been reported with the use of codeine.[Ref]
One study of a patient with exercise-induced anaphylaxis and three control subjects has found a correlation between codeine wheal size and recent exercise.[Ref]
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