Fortabs Side Effects
Generic Name: aspirin / butalbital / caffeine
Note: This page contains information about the side effects of aspirin / butalbital / caffeine. Some of the dosage forms included on this document may not apply to the brand name Fortabs.
For the Consumer
Applies to aspirin / butalbital / caffeine: capsules, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking aspirin / butalbital / caffeine:
Dizziness; drowsiness; gas; lightheadedness; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; fast heartbeat; red, swollen, or blistered skin; stomach pain; unusual bruising or bleeding.
For Healthcare Professionals
Applies to aspirin / butalbital / caffeine: oral capsule, oral tablet
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]
Gastrointestinal effects are common and include 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.
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.[Ref]
Renal effects of aspirin include 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]
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]
Hematologic effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) include increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.[Ref]
Aspirin hypersensitivity reactions include 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]
Dermatologic effects from the use of aspirin have been reported rarely and include Stevens-Johnson syndrome and a lichenoid eruption.[Ref]
Cases of aspirin-induced hepatoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.[Ref]
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 throxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]
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]
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]
Central nervous system effects in patients receiving aspirin include 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.
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]
Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]
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, 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.[Ref]
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.
Many side-effects noted with aspirin use are dose-related.[Ref]
Musculoskeletal effects of rhabdomyolysis have occurred in patients receiving aspirin.[Ref]
Respiratory effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.
Dyspnea has been reported frequently with the use of butalbital.[Ref]
Renal effects of interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency, and renal failure have occurred in patients receiving aspirin.[Ref]
Endocrine effects of aspirin use have been reported to include hypoglycemia (children) and hyperglycemia.[Ref]
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.[Ref]
Cases of localized periorbital edema have been reported rarely in patients receiving aspirin.[Ref]
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2. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO "Frequency of major complications of aspirin, warfarin, and intravenous heparin for secondary stroke prevention: a population study." Ann Intern Med 130 (1999): 14-22
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5. He J, Whelton PK, Vu B, Klag MJ "Aspirin and risk of hemorrhagic stroke: a meta-analysis of randomized controlled trials." JAMA 280 (1998): 1930-35
6. Boissel JP "Individualizing aspirin therapy for prevention of cardiovascular events." JAMA 280 (1998): 1949-50
7. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94
8. Boyle CA, Berkowitz GS, LiVolsi VA, Ort S, Merino MJ, White C, Kelsey JL "Caffeine consumption and fibrocystic breast disease: a case-control epidemiologic study." J Natl Cancer Inst 72 (1984): 1015-9
9. Sawynok J "Pharmacological rationale for the clinical use of caffeine." Drugs 49 (1995): 37-50
10. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
11. Clementz GL, Dailey JW "Psychotropic effects of caffeine." Am Fam Physician 37 (1988): 167-72
Not all side effects for Fortabs may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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