"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Macrobid Side Effects Center
Medical Author: Charles Patrick Davis, MD, PhD
Macrobid (nitrofurantoin monohydrate/macrocrystals) is an antibacterial drug used to treat urinary tract and bladder infections caused by Escherichia coli or Staphyloccocus saprophyticus strains of bacteria that are sensitive to this drug. The drug is available as a generic under the name nitrofurantoin. Macrobid should not be used for pyelonephritis (kidney infections) or other deep tissue infections such as perinephric abscesses. Common side effects of Macrobid are nausea, vomiting, upset stomach, diarrhea, rust-colored or brownish urine, vaginal discharge, headaches, and gas (flatulence). Contact your doctor if you experience serious side effects of Macrobid including bloody or watery diarrhea, sudden chest pain, shortness of breath, cough, fever or chills, numbness or tingling in the hands or feet, or easy bruising.
Macrodid is available in 100 mg tablets for use in children >12 years old and adults. Macrobid should not be used in infants and its use in children <12 years old and pregnant females is not well documented. Lactating females should not use Macrobid. Infrequent but serious side effects include ulcerative colitis, pancreatitis, nystagmus, blood cell alterations and pulmonary complications such as pulmonary hypertension, swelling and short of breath. Some serious side effects appear only after long -term use of the drug. Also, chronic use to suppress urinary infections may allow other bacteria to proliferate and cause infections. Patients with blood or liver problems should avoid Macrobid use. Magnesium trisilicate, found in antacids reduces the adsorption of Macrobid.
Our Macrobid Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Macrobid in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using nitrofurantoin and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- shortness of breath, running out of breath easily;
- sudden chest pain or discomfort, wheezing, dry cough or hack;
- fever, chills, body aches, unexplained weight loss;
- peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- pale skin, easy bruising, confusion or weakness;
- patchy skin color, red spots, or a severe blistering, peeling, and red skin rash; or
- severe headache, ringing in your ears, dizziness, vision problems, pain behind your eyes.
Less serious side effects may include:
- upset stomach, vomiting;
- mild diarrhea;
- rust-colored or brownish urine; or
- vaginal itching or discharge.
Read the entire detailed patient monograph for Macrobid (Nitrofurantoin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Macrobid Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may cause your urine to turn dark yellow or brown in color. This is usually a harmless, temporary effect and will disappear when the medication is stopped. However, dark brown urine can also be a sign of rare side effects (liver problems or anemia). Therefore, seek immediate medical attention if you notice dark urine along with any of the following symptoms: persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, tiredness, fast/pounding heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: eye pain, vision changes, mental/mood changes, persistent/severe headaches, new signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.
Seek immediate medical attention if you develop the following rare but very serious side effects: numbness/tingling of the hands/feet, unusual muscle weakness.
This medication may rarely cause very serious (possibly fatal) lung problems. Lung problems may occur within the first month of treatment or after long-term use of nitrofurantoin (generally for 6 months or longer). Get medical help right away if you develop symptoms of lung problems, including: persistent cough, chest pain, shortness of breath/trouble breathing, joint/muscle pain, bluish/purplish skin.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur during treatment or even weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
Use of nitrofurantoin for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Macrobid (Nitrofurantoin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Macrobid FDA Prescribing Information: Side Effects
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:
Neurologic: Dizziness, drowsiness, amblyopia
Respiratory: Acute pulmonary hypersensitivity reaction (see WARNINGS)
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. (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.)
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.
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. (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.
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; chills; and vasculitis (sometimes associated with pulmonary reactions) have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with nitrofurantoin formulations.
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 (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.
Read the entire FDA prescribing information for Macrobid (Nitrofurantoin)
Additional Macrobid Information
Macrobid - User Reviews
Macrobid User Reviews
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