Macrobid Side Effects

Generic Name: nitrofurantoin

Please note - some side effects for Macrobid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Macrobid - for the Consumer

Macrobid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Macrobid:

Gas; headache; loss of appetite; mild diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or watery stools; bluish skin or nails; blurred vision or other vision changes; butterfly-shaped rash on the nose and cheeks; confusion; joint or muscle pain; mood or mental changes (eg, depression); persistent feeling of being unwell; persistent headache; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe stomach pain or cramps; symptoms of liver problems (eg, yellowing of the eyes or skin, pale stools, severe or persistent nausea or loss of appetite, stomach pain); symptoms of lung problems (eg, fever, chills, chest pain, shortness of breath, unusual or persistent cough); tingling, numbness, or burning of the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness.

Macrobid Side Effects - for the Professional

Macrobid

In clinical trials of Macrobid, the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical adverse events reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below within each body system in order of decreasing frequency:

Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, emesis

Neurologic: Dizziness, drowsiness, amblyopia

Respiratory: Acute pulmonary hypersensitivity reaction

Allergic: Pruritus, urticaria

Dermatologic: Alopecia

Miscellaneous: Fever, chills, malaise

The following additional clinical adverse events have been reported with the use of nitrofurantoin:

Gastrointestinal: Sialadenitis, pancreatitis. 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.

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.

Asthenia, vertigo, and nystagmus also have 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.

Respiratory:

CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR WITH THE USE OF NITROFURANTOIN.

CHRONIC PULMONARY REACTIONS GENERALLY OCCUR 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 DEGREE 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 or 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.

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 necrosis, occur rarely.

Allergic: Lupus-like syndrome associated with pulmonary reaction to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; anaphylaxis; arthralgia; myalgia; drug fever; and chills have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with nitrofurantoin formulations.

Dermatologic: Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely.

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.

In clinical trials of Macrobid, the most frequent laboratory adverse events (1-5%), without regard to drug relationship, were as follows: eosinophilia, increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus. The following laboratory adverse events also have been reported with the use of nitrofurantoin: glucose-6-phosphate dehydrogenase deficiency anemia, 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.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, anorexia, diarrhea, and abdominal pain. These adverse effects occur more frequently with Furadantin, the crystalline form of the drug. Administration of the drug with food reduces gastrointestinal intolerance. Sialadenitis, pancreatitis, parotitis (rare), and pseudomembranous colitis have also been reported.

Comparative studies of the gastrointestinal adverse effects of the crystalline form (Furadantin) and the macrocrystalline form (Macrodantin) reported 14% to 34% GI intolerance with the crystalline form and 8% to 13% with the macrocrystalline form. In patients who were unable to tolerate Furadantin, 80% were able to tolerate Macrodantin.

Pancreatitis due to nitrofurantoin has been reported. In one case the patient experienced cholestatic jaundice secondary to edema of the pancreas.

Respiratory

Respiratory side effects associated with nitrofurantoin therapy have occurred as both acute and chronic events. Acute pulmonary reactions have manifested as a type of hypersensitivity, and have occurred rapidly in patients who were previously sensitized. Of one group of 447 pulmonary reactions reported, 89% were of the acute type. Patients will commonly have eosinophilia. Lung changes generally include alveolar infiltrates. Alveolar hemorrhage and death have been reported. Symptoms generally resolved within 24 to 48 hours after nitrofurantoin is discontinued.

Chronic pulmonary reactions occur after six months of therapy and are generally more severe. Biopsy often reveals interstitial fibrosis. Eosinophilia is less common. Positive antinuclear antibodies are reported in 60% to 66% of patients, and patients commonly exhibit abnormal liver function tests. Resolution of symptoms usually occurs over a few months, although deaths have been reported. It has been suggested that the mechanism of this reaction is a combination of drug toxicity and an immune reaction.

Respiratory system side effects have included both acute and chronic pulmonary toxicity. Acute toxicity has occurred from within a few hours to 3 weeks after therapy was started and consisted of dyspnea, cough, fever, and chills. Chronic toxicity has generally occurred after 6 months of therapy and has presented with an insidious onset of dyspnea, cough, malaise, and fatigue. Cyanosis (rare), alveolar infiltrates, alveolar hemorrhage (including fatal cases), interstitial fibrosis, and pneumonitis have been reported.

Cardiovascular

Cardiovascular side effects have included changes in EKG (such as nonspecific ST/T wave changes or bundle branch block) associated with pulmonary reactions.

Hepatic

Most acute hepatic reactions are self-limiting and resolve within a few days. Patients who experience chronic reactions often have positive antinuclear antibodies (77%) and may develop chronic active hepatitis or hepatic necrosis. Liver function tests generally return to normal after a few months, although deaths due to hepatic failure have been reported.

Hepatotoxicity with concurrent pulmonary effects following the use of nitrofurantoin has been reported and may be mediated by the immune system. A case of hepatotoxicity accompanied by elevations in serum immune globulins (IgG) has been reported. The authors theorized that cytotoxic T cells (CD8) were involved in the liver damage. They postulated that the antigen-antibody complex was removed when the drug was discontinued as evidenced by the patient's rapidly corrected liver enzyme levels.

Hepatic side effects have included elevated transaminase levels, hepatitis (including fatal cases), elevated bilirubin, cholestatic jaundice, and hepatic necrosis. Hepatotoxicity with concurrent pulmonary reactions has occurred rarely. Hepatic toxicity has occurred more often following lengthy therapy (6 months or more) and has presented with jaundice, abdominal pain, malaise, nausea, and anorexia.

Nervous system

Peripheral neuropathy may develop after a few days to several months of therapy. There is no consistent relationship between the dose, length of therapy, and neuropathy development. In a review of 100 cases of peripheral neuropathy, 34 experienced total regression, 45 had partial regression, 13 had no change, and 8 died. Nitrofurantoin therapy in those at risk is not recommended.

Nervous system side effects have included headache or dizziness. Less frequently, severe and debilitating peripheral neuropathy due to nitrofurantoin may occur. Neuropathy generally begins as paresthesia of the lower extremities and the hands and progresses to muscle weakness and wasting. Patients at risk include the elderly and those with renal impairment, anemia, vitamin B12 deficiency, diabetes, or debilitating diseases. Vertigo, cerebellar dysfunction, benign intracranial hypertension (pseudotumor cerebri), and confusion have been reported rarely.

Hematologic

Hematologic side effects have included hemolytic anemia, leukopenia, agranulocytosis, granulocytopenia, megaloblastic anemia, cyanosis secondary to methemoglobinemia, eosinophilia, decreased hemoglobin, glucose-6-phosphate dehydrogenase deficiency anemia, thrombocytopenia, and aplastic anemia.

Hypersensitivity

Hypersensitivity side effects have included lupus-like syndrome, angioedema, eruptions (maculopapular, erythematous, and eczematous), anaphylaxis, arthralgia, myalgia, drug fever, and chills.

Dermatologic

Dermatologic side effects have included exfoliative dermatitis, erythema multiforme, and Stevens-Johnson syndrome.

Ocular

Ocular side effects have included amblyopia, diplopia, nystagmus, and optic neuritis. Retinopathy due to intraretinal crystals has been reported in a patient with a nine year history of nitrofurantoin use.

Other

Other side effects have included systemic lupus erythematous-like reactions (rare), asthenia, fever, chills, and superinfections due to resistant organisms.

Renal

Renal side effects have rarely included acute interstitial nephritis.

Psychiatric

Psychiatric side effects have rarely included depression and psychotic reactions.

Metabolic

Metabolic side effects have included increased serum phosphorus, alkaline phosphatase, lactate dehydrogenase, and creatine phosphokinase.

Genitourinary

Genitourinary side effects have included dark discoloration of urine.

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