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MIRALAX

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Miralax Adverse Events Reported to the FDA Over Time

How are Miralax adverse event reports trending over time?

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

Most Common Miralax Adverse Events Reported to the FDA

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

Age 1-9 Years

Abnormal Behaviour
8 (.23%)
Tic
6 (.17%)
Anxiety
5 (.14%)
Convulsion
5 (.14%)
Aggression
4 (.11%)
Anger
4 (.11%)
Insomnia
4 (.11%)
Constipation
3 (.09%)
Crying
3 (.09%)
Diarrhoea
3 (.09%)
Drug Dependence
3 (.09%)
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Faecal Incontinence
3 (.09%)
Flatulence
3 (.09%)
Pain In Extremity
3 (.09%)
Personality Change
3 (.09%)
Rash
3 (.09%)
Abdominal Distension
2 (.06%)
Abdominal Pain
2 (.06%)
Anaphylactic Reaction
2 (.06%)
Blood Glucose Increased
2 (.06%)
Blood Lead Increased
2 (.06%)
Condition Aggravated
2 (.06%)
Dehydration
2 (.06%)
Encopresis
2 (.06%)
Failure To Thrive
2 (.06%)
Fear
2 (.06%)
Gait Disturbance
2 (.06%)
Gastrointestinal Disorder
2 (.06%)
Incorrect Dose Administered
2 (.06%)
Irritability
2 (.06%)
Kidney Enlargement
2 (.06%)
Malaise
2 (.06%)
Middle Insomnia
2 (.06%)
Muscle Spasms
2 (.06%)
Pain
2 (.06%)
Psychomotor Hyperactivity
2 (.06%)
Screaming
2 (.06%)
Swelling Face
2 (.06%)
Vomiting
2 (.06%)
Abasia
1 (.03%)
Abnormal Dreams
1 (.03%)
Abnormal Faeces
1 (.03%)
Acute Lymphocytic Leukaemia
1 (.03%)
Affective Disorder
1 (.03%)
Anion Gap Increased
1 (.03%)
Anorectal Disorder
1 (.03%)
Anuria
1 (.03%)
Arrhythmia
1 (.03%)
Arthralgia
1 (.03%)
Back Pain
1 (.03%)
Blister
1 (.03%)
Blood Alkaline Phosphatase Increase...
1 (.03%)
Blood Sodium Decreased
1 (.03%)
Bronchospasm
1 (.03%)
Bruxism
1 (.03%)
Communication Disorder
1 (.03%)
Contusion
1 (.03%)
Dark Circles Under Eyes
1 (.03%)
Dental Caries
1 (.03%)
Depression
1 (.03%)
Developmental Coordination Disorder
1 (.03%)
Disturbance In Attention
1 (.03%)
Drug Effect Decreased
1 (.03%)
Drug Hypersensitivity
1 (.03%)
Drug Ineffective
1 (.03%)
Drug Prescribing Error
1 (.03%)
Dry Skin
1 (.03%)
Dysarthria
1 (.03%)
Dyskinesia
1 (.03%)
Dysphemia
1 (.03%)
Early Satiety
1 (.03%)
Emotional Disorder
1 (.03%)
Excessive Eye Blinking
1 (.03%)
Fall
1 (.03%)
Feeling Abnormal
1 (.03%)
Feeling Drunk
1 (.03%)
Frustration
1 (.03%)
Gastrointestinal Injury
1 (.03%)
Grand Mal Convulsion
1 (.03%)
Grunting
1 (.03%)
Haematochezia
1 (.03%)
Haemorrhage
1 (.03%)
Head Banging
1 (.03%)
Headache
1 (.03%)
Hordeolum
1 (.03%)
Hyperphosphataemia
1 (.03%)
Hyponatraemia
1 (.03%)
Inappropriate Affect
1 (.03%)
Injury
1 (.03%)
Lethargy
1 (.03%)
Mental Status Changes
1 (.03%)
Mood Altered
1 (.03%)
Mood Swings
1 (.03%)
Movement Disorder
1 (.03%)
Muscle Twitching
1 (.03%)
Nausea
1 (.03%)
Nervousness
1 (.03%)
Nightmare
1 (.03%)
No Therapeutic Response
1 (.03%)
Oedema Peripheral
1 (.03%)
Oral Herpes
1 (.03%)

All Ages and Genders

Drug Ineffective
155 (4.42%)
Incorrect Drug Administration Durat...
139 (3.96%)
Diarrhoea
108 (3.08%)
Overdose
108 (3.08%)
Faeces Discoloured
71 (2.02%)
Nausea
58 (1.65%)
Abdominal Distension
54 (1.54%)
Constipation
54 (1.54%)
Vomiting
52 (1.48%)
Flatulence
51 (1.45%)
Asthenia
41 (1.17%)
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Convulsion
39 (1.11%)
Dehydration
39 (1.11%)
Off Label Use
39 (1.11%)
Abdominal Pain
38 (1.08%)
Abdominal Pain Upper
37 (1.05%)
Drug Effect Decreased
36 (1.03%)
Dizziness
35 (1%)
Rectal Haemorrhage
35 (1%)
Muscle Spasms
34 (.97%)
Pruritus
34 (.97%)
Swollen Tongue
34 (.97%)
Dysgeusia
33 (.94%)
Pain
32 (.91%)
Haematochezia
30 (.85%)
Urticaria
29 (.83%)
Malaise
28 (.8%)
Rash
27 (.77%)
Dyspnoea
26 (.74%)
Blood Pressure Increased
25 (.71%)
Condition Aggravated
25 (.71%)
Fibromyalgia
25 (.71%)
Headache
24 (.68%)
Pharyngeal Oedema
24 (.68%)
Fatigue
22 (.63%)
Oedema Peripheral
22 (.63%)
Feeling Abnormal
20 (.57%)
Underdose
20 (.57%)
Hypersensitivity
19 (.54%)
Swelling Face
19 (.54%)
Drug Hypersensitivity
18 (.51%)
Loss Of Consciousness
18 (.51%)
Faecal Incontinence
17 (.48%)
Abnormal Faeces
16 (.46%)
Chest Pain
16 (.46%)
Frequent Bowel Movements
16 (.46%)
Abdominal Discomfort
15 (.43%)
Haemorrhage
15 (.43%)
Inappropriate Schedule Of Drug Admi...
15 (.43%)
Pain In Extremity
15 (.43%)
Weight Decreased
15 (.43%)
Anxiety
14 (.4%)
Blood Pressure Decreased
14 (.4%)
Hypertension
14 (.4%)
No Therapeutic Response
14 (.4%)
Speech Disorder
14 (.4%)
Lip Swelling
13 (.37%)
Abnormal Behaviour
12 (.34%)
Blood Glucose Increased
12 (.34%)
Drug Dependence
12 (.34%)
Expired Drug Administered
12 (.34%)
Glossodynia
12 (.34%)
Incorrect Drug Administration Rate
12 (.34%)
Pyrexia
12 (.34%)
Heart Rate Increased
11 (.31%)
Hypoaesthesia
11 (.31%)
Insomnia
11 (.31%)
Therapeutic Product Ineffective
11 (.31%)
Anaphylactic Shock
10 (.28%)
Drug Exposure During Pregnancy
10 (.28%)
Gait Disturbance
10 (.28%)
Incorrect Dose Administered
10 (.28%)
Medication Error
10 (.28%)
Memory Impairment
10 (.28%)
Swelling
10 (.28%)
Tremor
10 (.28%)
Wrong Technique In Drug Usage Proce...
10 (.28%)
Nail Disorder
9 (.26%)
Retching
9 (.26%)
Talipes
9 (.26%)
Burning Sensation
8 (.23%)
Cardiac Disorder
8 (.23%)
Confusional State
8 (.23%)
Dyspepsia
8 (.23%)
Erythema
8 (.23%)
Eye Swelling
8 (.23%)
Haemorrhoids
8 (.23%)
Hypotension
8 (.23%)
Muscular Weakness
8 (.23%)
Pollakiuria
8 (.23%)
Renal Function Test Abnormal
8 (.23%)
Urinary Tract Infection
8 (.23%)
Blood Potassium Decreased
7 (.2%)
Chills
7 (.2%)
Colonic Polyp
7 (.2%)
Drug Ineffective For Unapproved Ind...
7 (.2%)
Dry Mouth
7 (.2%)
Dry Skin
7 (.2%)
Dysphagia
7 (.2%)
Eructation
7 (.2%)
Escherichia Urinary Tract Infection
7 (.2%)

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

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

Age 1-9 Years

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All Ages and Genders

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ExportShare/Embed Graph Export Export Data

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

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

Constipation
1276
Product Used For Unknown Indication
488
Drug Use For Unknown Indication
365
Medical Observation
155
Colonoscopy
48
Laxative Supportive Care
30
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Irritable Bowel Syndrome
24
Off Label Use
19
Constipation Prophylaxis
18
Bowel Preparation
18
Bowel Movement Irregularity
16
Gastrointestinal Disorder
15
Prophylaxis
12
Faeces Hard
11
Crohns Disease
10
Abnormal Faeces
10
Gastrointestinal Motility Disorder
10
Ill-defined Disorder
7
Diarrhoea
7
Nausea
6
Infrequent Bowel Movements
6
Faecaloma
5
Small Intestinal Obstruction
5
Gastrooesophageal Reflux Disease
5
Intestinal Functional Disorder
5
Intestinal Obstruction
4
Frequent Bowel Movements
4
Abdominal Distension
4
Sjogrens Syndrome
3
Abdominal Discomfort
3
Pain
3
Diverticulitis
3
Gastric Disorder
3
Colitis
3
Gastrointestinal Disorder Therapy
2
Drug Therapy
2
Obstruction
2
Restless Legs Syndrome
2
Enema Administration
2
Rectal Prolapse
2
Menopause
2
Incontinence
2
Endoscopy
2
Megacolon
2
Functional Gastrointestinal Disorde...
2
Impaired Gastric Emptying
2
Nuclear Magnetic Resonance Imaging
2
Rectal Fissure
1
Haemorrhoid Operation
1
Foetal Exposure During Pregnancy
1
Preoperative Care
1

Child Safety Precautions


Drug Labels

LabelLabelerEffective
MiralaxMSD Consumer Care, Inc.06-FEB-13
MiralaxCardinal Health22-MAR-13

Miralax Case Reports

What Miralax 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 Miralax. 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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