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Midol Adverse Events Reported to the FDA Over Time

How are Midol adverse event reports trending over time?

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

Most Common Midol Adverse Events Reported to the FDA

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

Completed Suicide
1770 (4.87%)
Drug Toxicity
686 (1.89%)
Cardiac Arrest
568 (1.56%)
Respiratory Arrest
516 (1.42%)
Death
505 (1.39%)
Cardio-respiratory Arrest
461 (1.27%)
No Adverse Event
452 (1.24%)
Nausea
411 (1.13%)
Vomiting
392 (1.08%)
Overdose
340 (.93%)
Dizziness
338 (.93%)
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Dyspnoea
321 (.88%)
Drug Ineffective
313 (.86%)
Renal Failure Acute
274 (.75%)
Gastrointestinal Haemorrhage
270 (.74%)
Hypotension
268 (.74%)
Somnolence
263 (.72%)
Headache
262 (.72%)
Intentional Drug Misuse
247 (.68%)
Diarrhoea
241 (.66%)
Pain
234 (.64%)
Haemoglobin Decreased
211 (.58%)
Suicide Attempt
210 (.58%)
Intentional Overdose
209 (.57%)
Multiple Drug Overdose
209 (.57%)
Poisoning
196 (.54%)
Rash
191 (.53%)
Hypersensitivity
180 (.49%)
Pruritus
180 (.49%)
Tachycardia
178 (.49%)
Abdominal Pain
177 (.49%)
Haematemesis
175 (.48%)
Multiple Drug Overdose Intentional
168 (.46%)
Abdominal Pain Upper
167 (.46%)
Anaemia
166 (.46%)
Chest Pain
165 (.45%)
Asthenia
164 (.45%)
Loss Of Consciousness
161 (.44%)
Gastric Ulcer
160 (.44%)
Pyrexia
160 (.44%)
Urticaria
160 (.44%)
Drug Abuse
159 (.44%)
Fatigue
156 (.43%)
Heart Rate Increased
153 (.42%)
Insomnia
153 (.42%)
Convulsion
152 (.42%)
Confusional State
149 (.41%)
Dysmenorrhoea
148 (.41%)
Drug Interaction
147 (.4%)
Feeling Abnormal
134 (.37%)
Malaise
133 (.37%)
Agitation
130 (.36%)
Abdominal Discomfort
128 (.35%)
Back Pain
127 (.35%)
Arthralgia
120 (.33%)
Coma
120 (.33%)
Oedema Peripheral
117 (.32%)
Melaena
115 (.32%)
Pain In Extremity
111 (.31%)
Condition Aggravated
110 (.3%)
Anxiety
109 (.3%)
Rectal Haemorrhage
109 (.3%)
Duodenal Ulcer
108 (.3%)
Gastric Haemorrhage
107 (.29%)
Renal Failure
107 (.29%)
Incorrect Dose Administered
104 (.29%)
Drug Hypersensitivity
103 (.28%)
Hyperhidrosis
103 (.28%)
Tremor
103 (.28%)
Haemorrhage
102 (.28%)
Pulmonary Oedema
99 (.27%)
Dehydration
97 (.27%)
Hypertension
93 (.26%)
Syncope
93 (.26%)
Lethargy
91 (.25%)
Vision Blurred
91 (.25%)
Asthma
90 (.25%)
Unresponsive To Stimuli
90 (.25%)
Upper Gastrointestinal Haemorrhage
90 (.25%)
International Normalised Ratio Incr...
88 (.24%)
Fall
86 (.24%)
Disorientation
85 (.23%)
Faeces Discoloured
82 (.23%)
Medication Error
82 (.23%)
Pneumonia
82 (.23%)
Blood Creatinine Increased
81 (.22%)
Aspartate Aminotransferase Increase...
80 (.22%)
Constipation
80 (.22%)
Hepatic Failure
80 (.22%)
Hyperkalaemia
80 (.22%)
Swelling Face
78 (.21%)
Hyponatraemia
76 (.21%)
Haematochezia
75 (.21%)
Atrial Fibrillation
74 (.2%)
Hypoaesthesia
74 (.2%)
Dyspepsia
73 (.2%)
Swelling
73 (.2%)
Accidental Overdose
72 (.2%)
Alanine Aminotransferase Increased
72 (.2%)
Erythema
71 (.2%)
Urinary Tract Infection
71 (.2%)

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

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

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

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

Drug Use For Unknown Indication
2257
Product Used For Unknown Indication
2130
Pain
1450
Premedication
1044
Rheumatoid Arthritis
751
Arthritis
648
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Osteoarthritis
535
Suicide Attempt
480
Back Pain
442
Dysmenorrhoea
420
Arthralgia
408
Headache
373
Prophylaxis
186
Insomnia
172
Analgesic Therapy
137
Inflammation
137
Hypersensitivity
128
Pruritus
118
Migraine
109
Ill-defined Disorder
104
Juvenile Arthritis
97
Pain In Extremity
92
Antiinflammatory Therapy
91
Musculoskeletal Pain
86
Gout
70
Sleep Disorder
68
Nasopharyngitis
68
Muscle Spasms
66
Pyrexia
56
Menstrual Disorder
49
Rash
49
Myalgia
48
Psoriatic Arthropathy
47
Completed Suicide
47
Toothache
47
Ankylosing Spondylitis
44
Fibromyalgia
42
Intentional Overdose
41
Cancer Pain
38
Neck Pain
34
Tumour Associated Fever
32
Sleep Disorder Therapy
31
Swelling
29
Sciatica
28
Accidental Exposure
26
Pain Management
26
Chest Pain
26
Urticaria
25
Abdominal Pain
25
Cough
24
Accidental Drug Intake By Child
23

Drug Labels

LabelLabelerEffective
Midol Extended ReliefBayer HealthCare LLC, Consumer Care27-JAN-11
MidolBayer HealthCare LLC - Consumer Care13-OCT-11

Midol Case Reports

What Midol 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 Midol. 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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