ADVERSE REACTIONS:
Respiratory:
CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR.
CHRONIC PULMONARY REACTIONS MAY OCCUR GENERALLY IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE, DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY REACTION. FEVER IS RARELY PROMINENT.
THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREES OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY, EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY.
In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe.
Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation of pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic. (See WARNINGS.)
Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions.
Cyanosis has been reported rarely.
Hepatic:
Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic neurosis, occur rarely. (See WARNINGS.)
Neurologic:
Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy (See WARNINGS.)
Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness have also been reported with the use of nitrofurantoin.
Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.
Dermatologic:
Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely. Transient alopecia also has been reported.
Allergic:
A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and chills have been reported. Hypersensitivity reactions present the most frequent spontaneously-reported adverse events in world-wide postmarketing experience with nitrofurantoin formulations.
Gastrointestinal:
Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. (See WARNINGS.)
Hematologic:
Cyanosis secondary to methemoglobinemia has been reported rarely.
Miscellaneous:
As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas species or Candida species, can occur. There are sporadic reports of Clostridium difficile superinfections, or pseudomembranous colitis, with the use of nitrofurantoin.
Laboratory Adverse Events:
The following laboratory adverse events have been reported with the use of nitrofurantoin; increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see WARNINGS), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FURADANTIN
Below is a sample of reports where side effects / adverse reactions may be related to Furadantin. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Furadantin side effects / adverse reactions in 62 year old male
Reported by a consumer/non-health professional from Netherlands on 2007-02-01
Patient: 62 year old male weighing 80.0 kg (176.0 pounds)
Reactions: Jaundice
Suspect drug(s):
Amoxicillin
Dosage: 625mg per day
Administration route: Oral
Indication: Infection
Start date: 2006-11-17
Furadantin
Dosage: 50mg per day
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2006-12-25
End date: 2006-12-31
Possible Furadantin side effects / adverse reactions in 66 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2007-02-06
Patient: 66 year old male
Reactions: Rash Maculo-Papular, Blister, Eosinophilia
Adverse event resulted in: hospitalization
Suspect drug(s):
Ciprofloxacin
Dosage: unk
Administration route: Oral
Indication: Prostatitis
Start date: 2006-05-06
End date: 2006-06-03
Nifluril
Dosage: unk
Administration route: Oral
Indication: Prostatitis
Start date: 2006-06-03
End date: 2006-06-04
Xatral
Dosage: unk
Administration route: Oral
Indication: Prostatitis
Start date: 2006-04-29
End date: 2006-06-06
Furadantin
Dosage: unk
Administration route: Oral
Indication: Prostatitis
Start date: 2006-06-03
End date: 2006-06-04
Possible Furadantin side effects / adverse reactions in 62 year old male
Reported by a consumer/non-health professional from Netherlands on 2007-02-08
Patient: 62 year old male weighing 80.0 kg (176.0 pounds)
Reactions: Jaundice
Suspect drug(s):
Amoxicillin + Clavulanate Potassium
Dosage: 625mg per day
Administration route: Oral
Indication: Infection
Start date: 2006-11-17
Furadantin
Dosage: 50mg per day
Administration route: Oral
Indication: Drug USE FOR Unknown Indication
Start date: 2006-12-25
End date: 2006-12-31
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