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Macrobid (Nitrofurantoin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS:

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 (see WARNINGS)

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. (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, 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. (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 necrosis, occur rarely. (See WARNINGS.)

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 (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.



REPORTS OF SUSPECTED MACROBID SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Macrobid. The information is not vetted and should not be considered as verified clinical evidence.

Possible Macrobid side effects / adverse reactions in 71 year old female

Reported by a consumer/non-health professional from United States on 2011-10-06

Patient: 71 year old female weighing 65.8 kg (144.7 pounds)

Reactions: Burning Sensation, Product Substitution Issue, Swelling Face, Palpitations, Swelling, Abasia, Urticaria, Asthenia

Suspect drug(s):
Macrobid

Other drugs received by patient: Macrobid



Possible Macrobid side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-10-06

Patient: 45 year old female

Reactions: Irritability, Pruritus, Dyspnoea, Chest Discomfort, Dyspnoea Exertional, Urticaria, Urinary Tract Infection, Pollakiuria

Suspect drug(s):
Prednisone

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-20

Macrobid
    Indication: Urinary Tract Infection

Gelnique
    Indication: Urinary Tract Infection

Prednisone
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-27

Prednisone

Other drugs received by patient: Multi-Vitamins; Ultram ER; Supplements; Flexeril; Excedrine Migraines; Sudafed 12 Hour; Dexilant



Possible Macrobid side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 45 year old female

Reactions: Irritability, Dyspnoea, Chest Discomfort, Pruritus, Urticaria, Urinary Tract Infection, Pollakiuria

Suspect drug(s):
Prednisone

Prednisone

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-20

Macrobid
    Indication: Urinary Tract Infection

Gelnique
    Indication: Urinary Tract Infection

Prednisone
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-27

Other drugs received by patient: Sudafed 12 Hour; Supplements; Flexeril; Ultram ER; Multi-Vitamins; Excedrine Migraines; Dexilant



See index of all Macrobid side effect reports >>

Drug label data at the top of this Page last updated: 2009-03-23

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