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MICONAZOLE NITRATE

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Miconazole Nitrate Adverse Events Reported to the FDA Over Time

How are Miconazole Nitrate adverse event reports trending over time?

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

Most Common Miconazole Nitrate Adverse Events Reported to the FDA

What are the most common Miconazole Nitrate adverse events reported to the FDA?

Drug Ineffective
408 (7.39%)
Vaginal Swelling
392 (7.1%)
Vulval Oedema
267 (4.84%)
Drug Interaction
227 (4.11%)
Vulvovaginal Discomfort
181 (3.28%)
International Normalised Ratio Incr...
159 (2.88%)
Vulvovaginal Burning Sensation
118 (2.14%)
Vaginal Discharge
111 (2.01%)
Vaginal Haemorrhage
111 (2.01%)
Abdominal Pain
81 (1.47%)
Vulvovaginal Pruritus
71 (1.29%)
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Drug Exposure During Pregnancy
70 (1.27%)
Hypersensitivity
69 (1.25%)
Dyspnoea
57 (1.03%)
Pain
54 (.98%)
Vulvovaginal Pain
53 (.96%)
Pruritus
47 (.85%)
Dysuria
45 (.82%)
Blister
43 (.78%)
Nausea
42 (.76%)
Genital Burning Sensation
39 (.71%)
Medication Error
37 (.67%)
Vomiting
37 (.67%)
Haematuria
36 (.65%)
Erythema
35 (.63%)
Abortion Spontaneous
34 (.62%)
Burning Sensation
33 (.6%)
Off Label Use
33 (.6%)
Haematoma
32 (.58%)
Oedema Genital
32 (.58%)
Dizziness
30 (.54%)
Urticaria
30 (.54%)
Wrong Technique In Drug Usage Proce...
30 (.54%)
Blood Urine Present
28 (.51%)
Pyrexia
27 (.49%)
Haemorrhage
25 (.45%)
Oedema Peripheral
25 (.45%)
Product Quality Issue
25 (.45%)
Intentional Drug Misuse
24 (.43%)
Headache
22 (.4%)
Oedema Mouth
22 (.4%)
Swelling
21 (.38%)
Accidental Exposure
20 (.36%)
Localised Oedema
20 (.36%)
Metrorrhagia
20 (.36%)
Application Site Pain
19 (.34%)
Caustic Injury
19 (.34%)
Maternal Drugs Affecting Foetus
19 (.34%)
Rash
18 (.33%)
Swelling Face
18 (.33%)
Application Site Burn
17 (.31%)
Incorrect Drug Administration Durat...
17 (.31%)
Insomnia
17 (.31%)
Skin Exfoliation
17 (.31%)
Amniotic Cavity Disorder
16 (.29%)
Amniotic Fluid Volume Decreased
16 (.29%)
Drug Administration Error
16 (.29%)
Drug Prescribing Error
16 (.29%)
Epistaxis
16 (.29%)
Expired Drug Administered
16 (.29%)
Foreign Body Trauma
16 (.29%)
Swollen Tongue
16 (.29%)
Thermal Burn
16 (.29%)
Abasia
15 (.27%)
Contusion
15 (.27%)
Loss Of Consciousness
15 (.27%)
Pregnancy
15 (.27%)
Vaginal Infection
15 (.27%)
Pain In Extremity
14 (.25%)
Skin Haemorrhage
14 (.25%)
Blindness Transient
13 (.24%)
Deafness Transitory
13 (.24%)
Drug Hypersensitivity
13 (.24%)
Genital Rash
13 (.24%)
Hyperacusis
13 (.24%)
Muscle Spasms
13 (.24%)
Vaginal Mucosal Blistering
13 (.24%)
Anaphylactic Reaction
12 (.22%)
Anaphylactoid Reaction
12 (.22%)
Application Site Vesicles
12 (.22%)
Cough
12 (.22%)
Fungal Infection
12 (.22%)
Hypoglycaemia
12 (.22%)
Premature Baby
12 (.22%)
Rash Erythematous
12 (.22%)
Vaginal Erythema
12 (.22%)
Vulvovaginal Mycotic Infection
12 (.22%)
Condition Aggravated
11 (.2%)
Feeling Abnormal
11 (.2%)
Gastrointestinal Haemorrhage
11 (.2%)
Somnolence
11 (.2%)
Vulvovaginal Dryness
11 (.2%)
Abdominal Pain Upper
10 (.18%)
Abortion Induced
10 (.18%)
Adverse Event
10 (.18%)
Anaemia
10 (.18%)
Application Site Pruritus
10 (.18%)
Application Site Reaction
10 (.18%)
Back Pain
10 (.18%)
Chest Pain
10 (.18%)
Dry Mouth
10 (.18%)

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This graph shows the top adverse events submitted to the FDA for Miconazole Nitrate, 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 Miconazole Nitrate 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 Miconazole Nitrate

What are the most common Miconazole Nitrate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Miconazole Nitrate, 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 Miconazole Nitrate 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 Miconazole Nitrate According to Those Reporting Adverse Events

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

Vulvovaginal Mycotic Infection
1128
Vaginal Mycosis
966
Fungal Infection
268
Drug Use For Unknown Indication
94
Oral Candidiasis
88
Product Used For Unknown Indication
68
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Genital Pruritus Female
46
Tinea Pedis
45
Vaginal Infection
30
Vaginal Burning Sensation
21
Oral Fungal Infection
20
Rash
14
Vulvovaginal Pruritus
12
Vulvovaginal Candidiasis
12
Onychomycosis
12
Vaginal Discharge
12
Drug Exposure During Pregnancy
12
Candidiasis
11
Pruritus
11
Tinea Cruris
9
Mouth Ulceration
8
Accidental Exposure
8
Dermatitis Diaper
8
Aphthous Stomatitis
8
Prophylaxis
7
Fungal Skin Infection
7
Stomatitis
7
Antifungal Prophylaxis
6
Hyperhidrosis
6
Tinea Infection
6
Vaginal Candidiasis
6
Vulvovaginal Discomfort
5
Hypothyroidism
5
Erythema
5
Antifungal Treatment
4
Mycosis Fungoides
4
Oesophageal Candidiasis
4
Vulvovaginitis
4
Genital Discharge
4
Dermatitis
3
Mucosal Inflammation
3
Bacterial Infection
3
Ill-defined Disorder
3
Unevaluable Event
3
Pulmonary Mycosis
2
Tongue Coated
2
Vaginal Odour
2
Dysuria
2
Vulvitis
2
Glossodynia
2
Vaginal Pain
2

Drug Labels

LabelLabelerEffective
Miconazole NitrateActavis Mid Atlantic LLC14-MAR-09
MitrazolantifungalHEALTHPOINT, LTD11-NOV-10
Miconazole NitrateRebel Distributors Corp17-FEB-11
VusionPhysicians Total Care, Inc.20-APR-11
Miconazole 7Actavis Mid Atlantic LLC16-SEP-11
Miconazole NitrateActavis Mid Atlantic LLC06-OCT-11
Miconazole 3 Combination PackCardinal Health11-NOV-11
Miconazole NitrateMcKesson09-DEC-11
Miconazole 3 Combination PackCardinal Health27-DEC-11
Miconazole Nitrate G&W; Laboratories, Inc.16-JAN-12
Miconazole Nitrate G&W; Laboratories, Inc.27-JAN-12
Miconazole NitrateQualitest Pharmaceuticals06-FEB-12
Lotrimin AntifungalMSD Consumer care, Inc.06-APR-12
Miconazole NitrateTaro Pharmaceuticals U.S.A., Inc.01-MAY-12
Miconazole NitrateTaro Pharmaceuticals U.S.A., Inc.02-MAY-12
Miconazole 7Preferred Pharmaceuticals, Inc.25-JUL-12
Miconazole NitrateTaro Pharmaceuticals U.S.A., Inc.10-AUG-12
Antifungal CreamActavis Mid Atlantic LLC21-AUG-12
VusionStiefel Laboratories Inc25-SEP-12
Miconazole NitrateRebel Distributors Corp26-SEP-12
Miconazole NitrateRebel Distributors Corp02-OCT-12
Miconazole NitratePhysicians Total Care, Inc.05-NOV-12
MiconazolePremier Value20-MAR-13

Miconazole Nitrate Case Reports

What Miconazole Nitrate 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 Miconazole Nitrate. 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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