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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use If Over 60 [what does this mean?]
Generic drug name: nitrofurantoin (nye troe FYOOR an toyn)
Brand name(s): FURADANTIN, MACROBID, MACRODANTIN
GENERIC: not available FAMILY: Other Drugs for Bacterial Infection
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Breast-feeding Warning

Nitrofurantoin is excreted in human milk. Because of the potential for serious adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]

Antibiotic-Associated Diarrhea

Antibiotic-associated diarrhea (AAD) is quite common and its incidence varies from 5% to 20% of patients depending on which antibiotic they are taking, although practically all antibiotics have been associated with AAD. Fortunately, most cases are mild and self-limited, ending with the cessation of use of the offending antibiotic. The antibiotics most commonly associated with this mild form of AAD include ampicillin, amoxicillin, cephalosporins and clindamycin.[1] There have been studies in children or adults in which the use of prophylactic yogurt in people using antibiotics has significantly reduced the occurrence or severity of AAD.[2],[3] However, 10% to 20% of all patients who get AAD (0.5% to 4% of patients using antibiotics) will get the more severe form of AAD known as pseudomembranous colitis (see below). If you are taking any antibiotic and develop diarrhea after starting to use the drug, call your physician to discuss whether another antibiotic should be used and to discuss the need for rehydration due to the fluid loss from the diarrhea.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Because antibiotic therapy has been associated with severe colitis, which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Treatment with antibacterial agents alters the normal flora of the colon and may permit over-growth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis."

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug that is clinically effective against C. difficile colitis.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy.

Facts About This Drug [top]

Nitrofurantoin (FURADANTIN, MACROBID, MACRODANTIN) is used to treat certain urinary tract infections.[4] It is a dangerous drug and should not be used in older adults. People over 60 who take this drug have such a high risk of harmful side effects that the World Health Organization has said older adults should not use it.[5] People taking this drug should ask their doctors to consider another drug that will be just as effective as nitrofurantoin and much safer.

Side effects

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Nitrofurantoin (FURADANTIN, MACROBID, MACRODANTIN) is used to treat certain urinary tract infections.[4] It is a dangerous drug and should not be used in older adults. People over 60 who take this drug have such a high risk of harmful side effects that the World Health Organization has said older adults should not use it.[5] People taking this drug should ask their doctors to consider another drug that will be just as effective as nitrofurantoin and much safer.

Side effects

A decrease in kidney function is a normal part of the aging process; because of this, the kidneys do not eliminate this drug from the body fast enough in older people. As a result, nitrofurantoin can accumulate to dangerously high levels in the bloodstream, causing side effects. Two of the possible side effects, a nerve disease called peripheral neuropathy and scarring of the lungs may be irreversible, and deaths from these side effects have been reported.[6]

The New Zealand Centre for Adverse Reactions Monitoring (CARM) reviewed reports of nitrofurantoin-induced lung toxicity in May 2002 after receiving a case of fatal lung toxicity resulting from long-term nitrofurantoin treatment. The patient was a 67-year-old woman with a history of severe rheumatoid arthritis who developed a cough after 20 months of nitrofurantoin treatment taken for severe recurrent urinary tract infections. Nitrofurantoin was continued for a further six months after lung toxicity was diagnosed. She died three months later.

In the CARM database, 34 percent of the nitrofurantoin side effect reports involve the respiratory system. Half of these reflect lung damage, including nine reports of pulmonary fibrosis (a disease in which the lung tissue becomes scarred and thickens, making it difficult to breathe). Twenty-six reports for respiratory system side effects were the result of chronic nitrofurantoin treatment.

The Danish Health and Medicines Authority reported that it had received increasing numbers of reports of pulmonary fibrosis in patients on long-term treatment with nitrofurantoin for urinary tract infections.[7]

The Australian Adverse Drug Reactions Advisory Committee has received multiple reports of liver damage associated with the use of nitrofurantoin, including some deaths.[8]

Warnings

<> The product label for nitrofurantoin carries the following bolded warning about lung toxicity:

 

ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, MACRODANTIN SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH.

CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS.[4]

Practice prevention

 

Practice measures to prevent urinary tract infections. Drink plenty of fluids, especially water.

While cranberry juice is unreliable as a cure for urinary tract infections, the juice may reduce odor from incontinence.[9]

Practice meticulous hygiene. For women, after using the toilet, wipe backward, not forward, then wash your hands.

Prepare and store foods properly, especially when traveling, to prevent diarrhea. Restrict caffeine, which widens the urethra.

Indwelling bladder catheters invite urinary tract infections. However, unless there are symptoms of urinary infection, it is not always necessary to take medication just because bacteria are found in a urine test.[10]

Women are particularly prone to repeated urinary tract infections. If urinary tract symptoms occur often, ask your doctor about keeping a supply of medication on hand.

Ideally, the antibiotic you use should be the most effective, least toxic, and least costly.[11],[12]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • anemia
  • pregnancy or are breast-feeding
  • disease that has severely weakened you
  • diabetes
  • electrolyte imbalance
  • vitamin B deficiency
  • G6PD deficiency
  • allergy to nitrofurantoin
  • peripheral neuropathy (muscle weakness and atrophy, pain, and numbness)
  • lung disease
  • kidney disease

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Check with your doctor if there is no improvement within a few days.
  • If using this drug for long-term therapy, have regular visits with your doctor to check your progress.
  • You may experience rust-yellow or brown urine and/or temporary hair loss when you use this drug. You do not need to call your doctor if you experience these symptoms.

How to Use This Drug [top]

  • Take this drug for the prescribed length of time. If you stop too soon, your symptoms could come back.
  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with food or milk.
  • For oral liquid:
  • Shake well before each dose.
  • Use a specially marked measuring spoon or other device.
  • The liquid may be mixed with water, milk, or fruit juices.
  • For extended-release capsules:
  • Do not break, chew, or crush long-acting forms of this drug.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drugs’ FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.

antacids containing magnesium trisilicate, BENEMID, probenecid.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • shortness of breath
  • swelling of face, mouth, hands, or feet
  • changes in facial skin color
  • sudden trouble in swallowing or breathing
  • hoarseness
  • joint pain
  • chills
  • fever shortly after onset of therapy
  • skin rash
  • muscle pain
  • itching
  • hives
  • chest pain
  • cough
  • general feeling of discomfort or illness
  • sore throat
  • unusual tiredness or weakness
  • unusual bleeding or bruising
  • pale or black, tarry stools
  • blood in urine or stools
  • pinpoint red spots on skin
  • dizziness
  • drowsiness
  • headache
  • burning, numbness, tingling, or painful sensations in arms, legs, hands, or feet
  • weakness in arms, hands, legs, or feet
  • wheezing or chest tightness
  • sores, ulcer, or white spots on lips or in mouth
  • swollen or painful glands
  • appetite loss
  • nausea or vomiting
  • visual changes, blurred vision, or loss of vision, with or without eye pain
  • blue skin color
  • pale skin
  • yellow eyes or skin
  • dark urine
  • continual severe abdominal or stomach pain or cramps
  • continuous unpleasant breath odor
  • vomiting blood
  • severe watery diarrhea (may be bloody)
  • confusion
  • mental depression
  • mood or mental changes
  • blistering, peeling, or loosening of skin and mucous membranes
  • red, thickened, or scaly skin
  • red skin lesions, often with a purple center

Call your doctor if these symptoms continue:

  • abdominal or stomach pain or upset
  • diarrhea
  • gas
  • appetite loss
  • nausea or vomiting
  • headache

Call your doctor if these symptoms continue after you stop taking this drug:

  • severe abdominal or stomach cramps or pain
  • fever
  • severe watery diarrhea (may be bloody)

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • liver function tests
  • kidney function tests
  • lung function tests

last reviewed April 30, 2021