Fiorinal with Codeine III Side Effects
Generic Name: aspirin / butalbital / caffeine / codeine
Note: This page contains information about the side effects of aspirin / butalbital / caffeine / codeine. Some of the dosage forms included on this document may not apply to the brand name Fiorinal with Codeine III.
Not all side effects for Fiorinal with Codeine III 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 aspirin / butalbital / caffeine / codeine: oral capsule
In addition to its needed effects, some unwanted effects may be caused by aspirin / 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 aspirin / butalbital / caffeine / codeine:Rare
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the vomit
- bloody urine
- blurred vision
- chills, fever
- dark urine
- decreased frequency or amount of urine
- difficulty breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- general tiredness and weakness
- hives, itching, skin rash
- increased thirst
- joint or muscle pain
- light-colored stools
- lower back or side pain
- nausea or vomiting
- 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
- shakiness in the legs, arms, hands, or feet skin
- sores, ulcers, or white spots in the mouth or on the lips
- swelling of the face, fingers, or lower legs
- tightness or pain in the chest
- trembling or shaking of the hands or feet
- upper right abdominal or stomach pain
- weight gain
- yellow eyes and skin
If any of the following symptoms of overdose occur while taking aspirin / butalbital / caffeine / codeine, get emergency help immediately:Symptoms of overdose
- Confusion as to time, place, or person
- continuing ringing or buzzing or other unexplained noise in the ears
- difficult or troubled breathing
- extremely high fever or body temperature
- hearing loss
- holding false beliefs that cannot be changed by fact
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- muscle cramps
- pale or blue lips, fingernails, or skin
- pale, clammy skin
- pinpoint pupils (black part of the eyes)
- trouble sleeping
- unusual bleeding or bruising
Some of the side effects that can occur with aspirin / 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:Rare
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- confusion about identity, place, and time
- constricted, pinpoint, or small pupils (black part of the eye)
- difficulty having a bowel movement (stool)
- dry mouth
- feeling of constant movement of self or surroundings
- feeling of warmth
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- high energy
- irregular heartbeats
- loss in sexual ability, desire, drive, or performance
- pain in the legs
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- severe mood or mental changes
- slurred speech
- trouble sitting still
- unexplained weight loss
- unusual behavior
For Healthcare Professionals
Applies to aspirin / butalbital / caffeine / codeine: oral capsule
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.
Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.[Ref]
Nervous system side effects in patients receiving codeine have included 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.
Central nervous system effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy and seizures. Tinnitus and subjective hearing loss (or both) may occur. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.[Ref]
Other side effects have been reported. Reye's syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults. Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.
Withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics have included 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]
Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]
Cardiovascular side effects of codeine have included hypotension and dizziness.
Cardiovascular effects of aspirin have been reported rarely and include salicylate-induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.[Ref]
Hypotension is rare with codeine use and has been reported most frequently with high doses.[Ref]
Gastrointestinal side effects have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.
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.
Nausea, vomiting, and constipation have been reported frequently with the use of codeine. Severe constipation and ileus resulting in colonic perforation have been also reported. Four cases of acute pancreatitis have been reported.[Ref]
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. One case-controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.[Ref]
Renal side effects of interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency, and renal failure have occurred in patients receiving aspirin.
Urinary retention has been reported with the use of codeine.[Ref]
Dermatologic side effects from the use of aspirin have been reported rarely and include Stevens-Johnson syndrome and a lichenoid eruption.
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]
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.[Ref]
Renal side effects including acute renal failure (which may respond to naloxone therapy) has been reported in association with codeine therapy.
Renal effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.[Ref]
Immunologic side effects have been reported. 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]
Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.[Ref]
Hypersensitivity side effects related to aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin-sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).[Ref]
The mechanism of aspirin-induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).[Ref]
Hepatic side effects including cases of aspirin-induced hepatotoxicity and cholestatic hepatitis (particularly at high doses)have been reported rarely.[Ref]
Oncologic side effects which were positive effects have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. Other studies have not found such a beneficial effect.[Ref]
Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has been reported in a patient on hemodialysis. Salicylates have also been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]
General side effects have been reported. Consumption of higher doses of caffeine (greater than 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.
In general, many side effects noted with aspirin use are dose-related.[Ref]
Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.[Ref]
Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.
Dyspnea has been reported frequently with the use of butalbital.[Ref]
Endocrine side effects of aspirin use have been reported to include hypoglycemia (children) and hyperglycemia.[Ref]
Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.[Ref]
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