ADVERSE REACTIONS
Commonly Observed
The most commonly reported adverse events associated with the use of Fiorinal with Codeine and not reported at an equivalent incidence by placebo-treated patients were nausea and/or abdominal pain, drowsiness, and dizziness.
Associated with Treatment Discontinuation
Of the 382 patients treated with Fiorinal with Codeine in controlled clinical trials, three (0.8%) discontinued treatment with Fiorinal with Codeine because of adverse events. One patient each discontinued treatment for the following reasons: gastrointestinal upset; lightheadedness and heavy eyelids; and drowsiness and generalized tingling.
Incidence in Controlled Clinical Trials
The following table summarizes the incidence rates of the adverse events reported by at least 1% of the Fiorinal with Codeine treated patients in controlled clinical trials comparing Fiorinal with Codeine to placebo, and provides a comparison to the incidence rates reported by the placebo-treated patients.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.
Adverse Events Reported by at Least 1% of Fiorinal with Codeine Treated Patients During Placebo Controlled Clinical Trials
|
Incidence Rate of Adverse Events
|
Body System/
Adverse Event
|
Fiorinal with Codeine
(N = 382)
|
Placebo
(N = 377)
|
| Central Nervous
|
|
|
| Drowsiness |
2.4% |
0.5% |
| Dizziness/Lightheadedness |
2.6% |
0.5% |
| Intoxicated Feeling |
1.0% |
0% |
| Gastrointestinal
|
|
|
| Nausea/Abdominal Pain |
3.7% |
0.8% |
Other Adverse Events Reported During Controlled Clinical Trials
The listing that follows represents the proportion of the 382 patients exposed to Fiorinal with Codeine while participating in the controlled clinical trials who reported, on at least one occasion, an adverse event of the type cited. All reported adverse events, except those already presented in the previous table, are included. It is important to emphasize that, although the adverse events reported did occur while the patient was receiving Fiorinal with Codeine, the adverse events were not necessarily caused by Fiorinal with Codeine.
Adverse events are classified by body system and frequency. “Frequent” is defined as an adverse event which occurred in at least 1/100 (1%) of the patients; all adverse events listed in the previous table are frequent. “Infrequent” is defined as an adverse event that occurred in less than 1/100 patients but at least 1/1000 patients. All adverse events tabulated below are classified as infrequent.
Central Nervous:
headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, and sluggishness.
Autonomic Nervous:
dry mouth and hyperhidrosis.
Gastrointestinal:
vomiting, difficulty swallowing, and heartburn.
Cardiovascular:
tachycardia.
Musculoskeletal:
leg pain and muscle fatigue.
Genitourinary:
diuresis.
Miscellaneous:
pruritus, fever, earache, nasal congestion, and tinnitus.
Voluntary reports of adverse drug events, temporally associated with Fiorinal with Codeine, that have been received since market introduction and that were not reported in clinical trials by the patients treated with Fiorinal with Codeine, are listed below. Many or most of these events may have no causal relationship with the drug and are listed according to body system.
Central Nervous:
abuse, addiction, anxiety, depression, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sedation, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Autonomic Nervous:
epistaxis, flushing, miosis, salivation.
Gastrointestinal:
anorexia, appetite increased, constipation, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasm, hiccup, mouth burning, pyloric ulcer.
Cardiovascular:
chest pain, hypotensive reaction, palpitations, syncope.
Skin:
erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.
Urinary:
kidney impairment, urinary difficulty.
Miscellaneous:
allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.
The following adverse drug events may be borne in mind as potential effects of the components of Fiorinal with Codeine. Potential effects of high dosage are listed in the
OVERDOSAGE
section of this insert.
Aspirin:
occult blood loss, hemolytic anemia, iron deficiency anemia, gastric distress, heartburn, nausea, peptic ulcer, prolonged bleeding time, acute airway obstruction, renal toxicity when taken in high doses for prolonged periods, impaired urate excretion, hepatitis.
Caffeine:
cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Codeine:
nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
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