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Miralax (Polyethylene Glycol 3350) - Serious Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Events (53)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Miralax (Polyethylene Glycol 3350) serious events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 53   Next >>

Possible Miralax side effects in

Reported by a lawyer from United States on 2012-08-15

Patient:

Reactions: Atrial Septal Defect, Patent Ductus Arteriosus, Ventricular Septal Defect, Maternal Exposure Timing Unspecified, Transposition of THE Great Vessels

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topiramate
    Dosage: 100 mg, 3x/day
    Start date: 2007-01-16
    End date: 2007-07-01

Flexeril
    Dosage: 10 mg, unk

Ibuprofen
    Dosage: 600 mg, 3x/day

Zantac
    Dosage: 150 mg, 2x/day

Miralax
    Dosage: unk

Other drugs received by patient: Folic Acid



Possible Miralax side effects in

Reported by a lawyer from United States on 2012-08-09

Patient:

Reactions: Atrial Septal Defect, Patent Ductus Arteriosus, Ventricular Septal Defect, Transposition of THE Great Vessels

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Indication: Foetal Exposure During Pregnancy

Ibuprofen

Miralax
    Indication: Foetal Exposure During Pregnancy

Flexeril
    Indication: Foetal Exposure During Pregnancy

Zantac
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Folic Acid



Possible Miralax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: male, weighing 89.4 kg (196.8 pounds)

Reactions: Medical Device Complication, Crohn's Disease, Uveitis, Rheumatoid Arthritis, Anal Fistula, Staphylococcal Infection, Joint Swelling, Deafness Unilateral, Skin Lesion, Otorrhoea, Gait Disturbance, Open Wound, Mobility Decreased, Blister

Drug(s) suspected as cause:
Miralax
    Indication: Colonoscopy
    Start date: 2011-12-23
    End date: 2011-12-23

Humira
    Indication: Crohn's Disease
    End date: 2009-05-01

Humira
    Indication: Rheumatoid Arthritis

Dulcolax
    Indication: Colonoscopy
    Start date: 2011-12-23
    End date: 2011-12-23



Possible Miralax side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18

Patient: 55 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Muscle Atrophy, Demyelinating Polyneuropathy

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Clearlax PEG 3350
    Dosage: one capful daily po
    Administration route: Oral
    Indication: Constipation
    Start date: 2010-01-01
    End date: 2012-03-07

Miralax
    Dosage: one capful daily po
    Administration route: Oral
    Indication: Constipation
    Start date: 2010-01-01
    End date: 2012-03-07



Possible Miralax side effects in 21 year old male

Reported by a individual with unspecified qualification from United States on 2012-06-08

Patient: 21 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Neuropsychiatric Syndrome, Fall, Skull Fracture, Loss of Consciousness, Haematoma, Convulsion, Cerebral Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: female, weighing 70.3 kg (154.7 pounds)

Reactions: Drug Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: 79 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Blood Pressure Increased, Dizziness, Headache, Eye Pain

Drug(s) suspected as cause:
Miralax

Other drugs received by patient: Metoprolol Tartrate; Metformin HCL; Digoxin



Possible Miralax side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-04-04

Patient: 63 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Dehydration, Therapeutic Product Ineffective, Hypersomnia

Drug(s) suspected as cause:
Miralax
    Dosage: 17 gm;once po
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-10-25

Miralax
    Dosage: 17 gm;once po
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-11-11
    End date: 2011-11-12

Other drugs received by patient: Gabitril; Dilantin; Carbatrol



Possible Miralax side effects in 72 year old female

Reported by a physician from United States on 2012-03-30

Patient: 72 year old female

Reactions: Blood Pressure Increased, Agitation, Dyspnoea, Vomiting, Constipation, Paraesthesia, Abdominal Pain Upper, Tremor, Anxiety, Panic Attack, Malaise, Palpitations, Memory Impairment

Drug(s) suspected as cause:
Miralax

Exelon
    Dosage: 3 mg, bid, oral
    Administration route: Oral

Other drugs received by patient: Cozaar; Vitamin D; Ranitin (Ranitidine Hydrochloride); Aspirin; Citracal (Calcium Citrate); Valacyclovir; Lisinopril; Crestor; Amlodipine; Paxil; Omeprazole



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-21

Patient: female

Reactions: Abdominal Pain, Diarrhoea, Haemorrhoidal Haemorrhage

Drug(s) suspected as cause:
Phillips' Milk OF Magnesia Liquid Original (Magnesium Hydroxide) Oral
    Dosage: consumer took the product in the morning
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Dosage: consumer took miralax at night, oral
    Indication: Product Used FOR Unknown Indication



Possible Miralax side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-03-21

Patient: 55 year old female, weighing 72.1 kg (158.7 pounds)

Reactions: Ear Discomfort, Pruritus, Dyspnoea, Urticaria, Rash, Pallor, Paraesthesia, Tremor, Abdominal Discomfort, Chest Pain, Swelling, Dizziness, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Miralax
    Dosage: ; po; 17 gm; po
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-06-09

Miralax
    Dosage: ; po; 17 gm; po
    Administration route: Oral
    Indication: Constipation
    Start date: 2012-02-03



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: female

Reactions: Abdominal Pain, Diarrhoea, Haemorrhoidal Haemorrhage

Drug(s) suspected as cause:
Miralax
    Dosage: consumer took miralax at night
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Phillips' Milk OF Magnesia Liquid Original
    Dosage: consumer took the product in the morning
    Indication: Product Used FOR Unknown Indication



Possible Miralax side effects in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 22 year old female

Reactions: Blood Pressure Increased, Heart Rate Increased, Musculoskeletal Stiffness, Feeling Abnormal

Drug(s) suspected as cause:
Clonidine
    Dosage: 0.1 mg, bid

Miralax

Fanapt
    Dosage: 12 mg, bid

Prilosec
    Dosage: 40 mg, bid

Seroquel
    Dosage: 100 mg, bid

Other drugs received by patient: Zantac; Nexium



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: female

Reactions: Faeces Discoloured

Drug(s) suspected as cause:
Aleve (Caplet)
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Miralax
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01



Possible Miralax side effects in 4 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 4 year old female, weighing 15.9 kg (34.9 pounds)

Reactions: Personality Change, Fear, Speech Disorder, TIC, Screaming, Anger, Crying, Scratch, Drug Effect Decreased, Vomiting, Abnormal Behaviour, Faecal Incontinence, Self Injurious Behaviour, Dysphemia, Aggression, Insomnia, Frustration, Inappropriate Affect

Drug(s) suspected as cause:
Miralax
    Dosage: 1/2 capful
    Administration route: Oral
    Indication: Faecaloma
    Start date: 2011-12-01
    End date: 2012-02-18

Miralax
    Dosage: 1/2 capful
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-12-01
    End date: 2012-02-18



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient:

Reactions: Gastrointestinal Infection, Large Intestine Perforation, Drug Ineffective, Procedural Complication, Treatment Noncompliance, Faecaloma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: female

Reactions: Intestinal Perforation, Sepsis, NO Therapeutic Response, Faecaloma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in 54 year old female

Reported by a individual with unspecified qualification from Germany on 2012-02-28

Patient: 54 year old female

Reactions: Death, Dyspnoea, Urinary Incontinence, Urosepsis, Progressive Multiple Sclerosis, Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Miralax

Gilenya
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Multiple Sclerosis

Other drugs received by patient: Cytomel; Oxycodone HCL; Cough Syrup; Stool Softener; Megestrol Acetate; Detrol; Macrodantin; Vitamin D; Nexium; Aspirin; Desyrel; Zyrtec; Soma; Diazepam; Benadryl



Possible Miralax side effects in 88 year old male

Reported by a physician from United States on 2012-02-24

Patient: 88 year old male, weighing 56.7 kg (124.7 pounds)

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: female

Reactions: Vomiting, Nausea, Urinary Tract Infection, Dehydration, Dizziness, Blood Magnesium Decreased, Blood Sodium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: 79 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Blood Pressure Increased, Headache, Eye Pain

Drug(s) suspected as cause:
Miralax

Other drugs received by patient: Metoprolol Tartrate; Digoxin; Metformin HCL



Possible Miralax side effects in 5 year old female

Reported by a consumer/non-health professional from United States on 2012-02-06

Patient: 5 year old female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Substitution Issue, Personality Change, Anxiety, Social Avoidant Behaviour, Abnormal Behaviour, Aggression

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-31

Patient: female

Reactions: Blood Pressure Increased, Headache, Eye Pain

Drug(s) suspected as cause:
Miralax

Other drugs received by patient: Metformin HCL



Possible Miralax side effects in 50 year old male

Reported by a physician from United States on 2012-01-23

Patient: 50 year old male, weighing 103.0 kg (226.6 pounds)

Reactions: Pain in Extremity, Lumbar Radiculopathy, Hypoaesthesia, Hepatic Enzyme Increased, Vitamin B12 Deficiency, Intermittent Claudication, Insomnia, Chest Pain, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lisinopril
    Dosage: 5 mg (5 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lortab
    Dosage: (as needed), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Vitamin B12
    Indication: Product Used FOR Unknown Indication

Vitamin D
    Indication: Product Used FOR Unknown Indication

Prilosec
    Dosage: 40 mg (40 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Docusate Sodium (Docusate Sodium)
    Indication: Constipation

Toprol-XL
    Dosage: 50 mg (50 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ultram
    Dosage: (2 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: (40 mg, 1 d), oral
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal

Baclofen
    Dosage: oral
    Administration route: Oral
    Indication: Muscle Relaxant Therapy

Other drugs received by patient: Aspirin



Possible Miralax side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-17

Patient: male, weighing 103.0 kg (226.6 pounds)

Reactions: Lumbar Radiculopathy, Hypoaesthesia, Myalgia, Vitamin B12 Deficiency, Intermittent Claudication, Coronary Artery Occlusion, Chest Pain, Liver Function Test Abnormal, Insomnia, Dizziness, Angiopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vitamin B-12
    Dosage: unk

Prilosec
    Dosage: 40 mg, 1x/day
    Administration route: Oral

Toprol-XL
    Dosage: 50 mg, 1x/day
    Administration route: Oral

Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal

Ultram
    Dosage: 50 mg, 1-2 tablets twice daily
    Administration route: Oral

Lortab
    Dosage: [hydrocodone 5 mg/ acetaminophen 500 mg], 1/2 to 1 tablet twice daily as needed
    Administration route: Oral

Lisinopril
    Dosage: 5 mg, 1x/day
    Administration route: Oral

Miralax
    Dosage: unk

Docusate Sodium
    Dosage: unk
    Indication: Constipation

Vitamin D
    Dosage: unk

Baclofen
    Dosage: 10 mg, 1/2 to 1 tablet up to twice daily
    Administration route: Oral
    Indication: Muscle Relaxant Therapy

Other drugs received by patient: Aspirin



Possible Miralax side effects in 31 year old female

Reported by a consumer/non-health professional from United States on 2012-01-05

Patient: 31 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Myalgia, Fibromyalgia

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-01-03

Patient: 71 year old male, weighing 88.5 kg (194.6 pounds)

Reactions: Product Label Issue, Drug Hypersensitivity

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-30

Patient: female, weighing 45.4 kg (99.9 pounds)

Reactions: Vomiting, Haemorrhoids, Abdominal Distension

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2011-09-25

Miralax
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vitamin B-12; Omeprazole; Promethazine; Vitamin C; Imuran; Lexapro; Xanax



Possible Miralax side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-29

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Wheezing, Bronchial Secretion Retention, Laryngitis

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-29

Patient: female, weighing 45.4 kg (99.9 pounds)

Reactions: Vomiting, Haemorrhoids, Abdominal Distension

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2011-09-25

Miralax
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Omeprazole; Vitamin C; Lexapro; Xanax; Promethazine; Vitamin B-12; Imuran



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