nitrofurantoin
Pharmaranks rates Nitrofurantoin 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Nitrofurantoin is a nitrofuran antibacterial used to treat Escherichia Coli Infections, Klebsiella Infections, Staphylococcal Infections, Urinary Tract Infections.
Nitrofuran Antibacterial · by Amneal
Generic of Furadantin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Nitrofurantoin
- Drug class
- Nitrofuran Antibacterial
- Form
- Capsule, Suspension
- Strength
- Nitrofurantoin 25MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Amneal
- Half-life
- about 20 minutes (roughly 0.3 hours) for the parent drug in adults with normal kidney function (how long it stays in your system)
- What the pharmacy pays
- ~$2.11 per ml — not your price
- FDA application
- ANDA201679
- Availability
- Discontinued (per FDA)
What is Nitrofurantoin?
From the FDA label:Nitrofurantoin oral suspension USP, a synthetic chemical, is a stable, yellow, crystalline compound. Nitrofurantoin oral suspension, USP is an antibacterial agent for specific urinary tract infections. Nitrofurantoin oral suspension, USP is available in 25 mg/5 mL liquid suspension for oral administration. Inactive Ingredients Nitrofurantoin oral suspension, USP contains anhydrous citric acid, artificial fruit flavor, carboxymethylcellulose sodium, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin insoluble, sodium citrate, and sorbitol solution 52ae3bb2-figure-01
How to use
Nitrofurantoin is sold in more than one form (Capsule and Suspension), and each is dosed differently. The instructions below come from the FDA label for application ANDA201679 — follow the label that came with the product you were actually prescribed.
Nitrofurantoin oral suspension should be given with food to improve drug absorption and, in some patients, tolerance. Adults 50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. Pediatric Patients 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). The following table is based on an average weight in each range receiving 5 to 6 mg/kg of body weight per 24 hours, given in four divided doses. It can be used to calculate an average dose of nitrofurantoin oral suspension (25 mg/5 mL) for pediatric patients. Table 3: Pediatric Dosing Table Weight in Kilograms (kg) Pediatric Doses (milliliters) and Frequency 7 kg to 11 kg 2.5 mL Four times Daily 12 kg to 21 kg 5 mL Four times Daily 22 kg to 30 kg 7.5 mL Four times Daily 31 kg to 41 kg 10 mL Four times Daily 42 kg or greater See Adult Dose Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation. For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED…
Side effects
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…
Warnings
Important safety information
Pulmonary reactions ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN ORAL SUSPENSION 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 (see RESPIRATORY REACTIONS ). Hepatotoxicity Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken. Neuropathy 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 disease may enhance the occurrence of peripheral neuropathy. Patients receiving long-term therapy should be monitored periodically for changes in renal function. Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations. Hemolytic anemia Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin. Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin. Hemolysis is an indication for discontinuing Nitrofurantoin oral suspension; hemolysis ceases when the drug is withdrawn. Clostridium difficile -associated diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin oral suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Who should not take Nitrofurantoin
Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin oral suspension is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.
Overdose — what happens if you take too much
Occasional incidents of acute overdosage of nitrofurantoin oral suspension have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. It is dialyzable.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Nitrofurantoin stay in your body?
The elimination half-life of nitrofurantoin is about 20 minutes (roughly 0.3 hours) for the parent drug in adults with normal kidney function — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The FDA/DailyMed nitrofurantoin labels (Macrobid, Macrodantin, Furadantin) do not print an explicit numeric elimination half-life; the Macrodantin label states the drug is "readily absorbed and rapidly excreted in urine," with about 35-38% of a 100 mg dose recovered unchanged in urine over 24 hours and low blood levels at therapeutic doses. Published pharmacology puts the serum (plasma) half-life at about 20 minutes, so the parent drug clears from the blood within a few hours. Nitrofurantoin is not a prodrug and has no active metabolite that outlasts it. Because it is eliminated mainly by the kidneys, blood levels run higher and it clears more slowly when kidney function is reduced — it is contraindicated when creatinine clearance is under 60 mL/min, and older adults (who more often have reduced kidney function) need extra caution. It is dosed several times a day precisely because it leaves the bloodstream so quickly; this short blood half-life is not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Macrodantin (nitrofurantoin macrocrystals) Capsules — FDA label, Clinical Pharmacology / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Capsule and Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Nitrofurantoin treat?
- Nitrofurantoin (Nitrofurantoin) may be used to treat escherichia coli infections, klebsiella infections, staphylococcal infections, urinary tract infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Nitrofurantoin rated?
- pharmaranks gives Nitrofurantoin a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Nitrofurantoin cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.11 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Bethkis — about $1.08 on the same basis.
- Is there a coupon or discount for Nitrofurantoin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nitrofurantoin. To pay less, Nitrofurantoin is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nitrofurantoin?
- Nitrofurantoin is marketed by Amneal. You can see Amneal's full profile, rating, and other products on pharmaranks.
- Is Nitrofurantoin a brand-name or generic drug?
- Nitrofurantoin is a generic medication; its active ingredient is Nitrofurantoin. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Nitrofurantoin available over the counter?
- No. Nitrofurantoin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nitrofurantoin come in?
- Nitrofurantoin is currently marketed as capsule and suspension, per the FDA's National Drug Code Directory.
- What class of drug is Nitrofurantoin?
- Nitrofurantoin is classified as nitrofuran antibacterial, per the FDA's Established Pharmacologic Class.
- Is Nitrofurantoin FDA-registered?
- Nitrofurantoin is on record with the U.S. FDA under application number ANDA201679. You can verify this on its official FDA label.
- Has Nitrofurantoin been recalled by the FDA?
- Nitrofurantoin has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Nitrofurantoin safe?
- There's no single safe-or-not verdict. pharmaranks gives Nitrofurantoin a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Nitrofurantoin?
- Nitrofurantoin's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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nitrofurantoin
70/100