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MACROBID

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Macrobid Adverse Events Reported to the FDA Over Time

How are Macrobid adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Macrobid, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Macrobid is flagged as the suspect drug causing the adverse event.

Most Common Macrobid Adverse Events Reported to the FDA

What are the most common Macrobid adverse events reported to the FDA?

Nausea
56 (2.43%)
Dyspnoea
50 (2.17%)
Headache
47 (2.04%)
Pyrexia
46 (2%)
Dizziness
42 (1.82%)
Chills
39 (1.69%)
Urinary Tract Infection
35 (1.52%)
Cystitis
33 (1.43%)
Drug Hypersensitivity
33 (1.43%)
Pain
31 (1.35%)
Fatigue
30 (1.3%)
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Malaise
30 (1.3%)
Abdominal Distension
29 (1.26%)
Blood Pressure Increased
28 (1.22%)
Loss Of Consciousness
28 (1.22%)
Weight Decreased
28 (1.22%)
Asthenia
27 (1.17%)
Burning Sensation
27 (1.17%)
Vomiting
26 (1.13%)
Palpitations
25 (1.09%)
Rash
25 (1.09%)
Abdominal Pain
22 (.96%)
Chest Pain
21 (.91%)
Ingrowing Nail
20 (.87%)
Urticaria
20 (.87%)
Blood Count Abnormal
19 (.83%)
Cholecystectomy
19 (.83%)
Cough
19 (.83%)
Insomnia
18 (.78%)
Toe Operation
18 (.78%)
Diarrhoea
16 (.69%)
Drug Interaction
16 (.69%)
Hypoaesthesia
16 (.69%)
Jaundice
16 (.69%)
Oedema Peripheral
16 (.69%)
Abdominal Pain Upper
15 (.65%)
Arthralgia
15 (.65%)
Erythema
15 (.65%)
Pain In Extremity
14 (.61%)
Paraesthesia
14 (.61%)
Pruritus
14 (.61%)
Alanine Aminotransferase Increased
13 (.56%)
Arteriosclerosis Coronary Artery
13 (.56%)
Back Pain
13 (.56%)
Feeling Abnormal
13 (.56%)
Abdominal Discomfort
12 (.52%)
Body Temperature Increased
12 (.52%)
Decreased Appetite
12 (.52%)
Dehydration
12 (.52%)
Chest Discomfort
11 (.48%)
Chromaturia
11 (.48%)
Tremor
11 (.48%)
Anxiety
10 (.43%)
Hepatitis
10 (.43%)
Aspartate Aminotransferase Increase...
9 (.39%)
Blood Alkaline Phosphatase Increase...
9 (.39%)
Blood Bilirubin Increased
9 (.39%)
Depression
9 (.39%)
Hypersensitivity
9 (.39%)
Anaphylactic Shock
8 (.35%)
Atrial Fibrillation
8 (.35%)
Drug Ineffective
8 (.35%)
Myalgia
8 (.35%)
White Blood Cell Count Increased
8 (.35%)
Bladder Operation
7 (.3%)
Condition Aggravated
7 (.3%)
Drug Exposure During Pregnancy
7 (.3%)
Hepatic Enzyme Increased
7 (.3%)
Neuropathy Peripheral
7 (.3%)
Premature Baby
7 (.3%)
Activities Of Daily Living Impaired
6 (.26%)
Blood Glucose Increased
6 (.26%)
Dysuria
6 (.26%)
Hypotension
6 (.26%)
Incision Site Abscess
6 (.26%)
Kidney Infection
6 (.26%)
Lung Disorder
6 (.26%)
Muscular Weakness
6 (.26%)
Pneumonia
6 (.26%)
Pruritus Generalised
6 (.26%)
Pulmonary Fibrosis
6 (.26%)
Syncope
6 (.26%)
Unevaluable Event
6 (.26%)
Vision Blurred
6 (.26%)
Anaemia
5 (.22%)
Appetite Disorder
5 (.22%)
Blood Potassium Decreased
5 (.22%)
Cardiac Arrest
5 (.22%)
Cholelithiasis
5 (.22%)
Confusional State
5 (.22%)
Drug Withdrawal Syndrome
5 (.22%)
Full Blood Count Decreased
5 (.22%)
Gamma-glutamyltransferase Increased
5 (.22%)
Gastric Disorder
5 (.22%)
Heart Rate Increased
5 (.22%)
Hepatic Failure
5 (.22%)
Hyperhidrosis
5 (.22%)
Interstitial Lung Disease
5 (.22%)
Lung Infiltration
5 (.22%)
Maternal Drugs Affecting Foetus
5 (.22%)
Muscle Spasms
5 (.22%)

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This graph shows the top adverse events submitted to the FDA for Macrobid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Macrobid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Macrobid

What are the most common Macrobid adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Macrobid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Macrobid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Macrobid According to Those Reporting Adverse Events

Why are people taking Macrobid, according to those reporting adverse events to the FDA?

Urinary Tract Infection
322
Product Used For Unknown Indication
74
Cystitis
71
Drug Use For Unknown Indication
39
Prophylaxis Urinary Tract Infection
19
Infection
13
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Crohns Disease
11
Infection Prophylaxis
10
Prophylaxis
9
Kidney Infection
8
Dysuria
7
Ill-defined Disorder
5
Sepsis
4
Foetal Exposure During Pregnancy
4
Vaginal Infection
4
Neurogenic Bladder
4
Bladder Disorder
3
Micturition Urgency
3
Drug Exposure During Pregnancy
3
Prostatitis
2
Urinary Retention
2
Pyrexia
2
Cystitis Noninfective
2
Antibiotic Prophylaxis
2
Pneumonia
2
Antibiotic Therapy
2
Swelling
2
Uterine Infection
1
Hypersensitivity
1
Escherichia Test Positive
1
Nephropathy
1
Uterine Disorder
1
Stent Placement
1
Stress Urinary Incontinence
1
Bladder Irrigation
1
Sexually Active
1
Cystoscopy
1
Urethritis
1
Drug Therapy
1
Vaginitis Bacterial
1
Blood Urine Present
1
Catheter Placement
1
Pollakiuria
1
Hypertension
1
Cystitis Escherichia
1
Urinary Tract Infection Bacterial
1
Uterine Rupture
1
Vaginitis Atrophic
1
Bladder Catheter Temporary
1
Urinary Tract Infection Enterococca...
1

Drug Labels

LabelLabelerEffective
MacrobidAlmatica Pharma Inc.07-JUN-12
MacrobidAlmatica Pharma Inc.07-JUN-12

Macrobid Case Reports

What Macrobid safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Macrobid. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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