Fiorinal with Codeine Side Effects

Generic name: aspirin / butalbital / caffeine / codeine

Note: This document contains side effect information about aspirin / butalbital / caffeine / codeine. Some of the dosage forms listed on this page may not apply to the brand name Fiorinal with Codeine.

Some side effects of Fiorinal with Codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to aspirin / butalbital / caffeine / codeine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking aspirin / butalbital / caffeine / codeine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• shallow breathing, slow heart rate;

• fast or pounding heart rate, muscle twitching;

• confusion, unusual thoughts or behavior;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• problems with urination; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy, shaky, anxious, or agitated;

• heartburn, mild nausea, vomiting, upset stomach, constipation, diarrhea;

• mood changes, sleep problems (insomnia);

• sweating, urinating more than usual; or

• ringing in your ears, blurred vision, or dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to aspirin / butalbital / caffeine / codeine: oral capsule

Nervous system

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.

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.

Other

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.

Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Cardiovascular

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.

Hypotension is rare with codeine use and has been reported most frequently with high doses.

Gastrointestinal

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.

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.

Genitourinary

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.

Dermatologic

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.

Renal

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.

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.

Immunologic

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.

Hematologic

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.

Hypersensitivity

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).

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).

Hepatic

Hepatic side effects including cases of aspirin-induced hepatotoxicity and cholestatic hepatitis (particularly at high doses)have been reported rarely.

Oncologic

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.

Metabolic

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.

General

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.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.

Respiratory

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.

Endocrine

Endocrine side effects of aspirin use have been reported to include hypoglycemia (children) and hyperglycemia.

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.

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