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Miralax (Polyethylene Glycol 3350) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Miralax (Polyethylene Glycol 3350) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (373)
Death (4)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Drug Ineffective (81)Incorrect Drug Administration Duration (76)Overdose (51)Diarrhoea (32)Drug Administered To Patient of Inappropriate AGE (23)Off Label Use (22)Drug Effect Decreased (17)Flatulence (16)Abdominal Distension (16)Dysgeusia (16)Vomiting (12)Nausea (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Miralax (Polyethylene Glycol 3350). For a complete list or a specific selection of reports, please use the links above.

Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Incorrect Drug Administration Duration, Nausea

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Off Label Use, Anal Pruritus, Drug Administered To Patient of Inappropriate AGE

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Therapeutic Product Ineffective

Drug(s) suspected as cause:
Miralax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Overdose, Drug Ineffective, Asthenia

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qd
    Administration route: Oral
    Indication: Constipation

Miralax
    Dosage: unk, bid
    Administration route: Oral
    Indication: Medical Observation

Other drugs received by patient: Magnesia [milk OF]



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Incorrect Drug Administration Duration, NO Therapeutic Response

Drug(s) suspected as cause:
Miralax
    Dosage: 17 g, qd
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-11-01
    End date: 2012-04-01

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Overdose

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Dysgeusia

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Dyspepsia

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qd
    Administration route: Oral
    Indication: Constipation
    Start date: 2012-07-16

Miralax
    Dosage: 17 g, unk
    Administration route: Oral
    Start date: 2012-07-05
    End date: 2012-07-13

Other drugs received by patient: Mobic; Zoloft; Omega-3-Acid Ethyl Esters; Simvastatin; Calcium (Unspecified) (+) Vitamin D (Unspecified); Cholecalciferol; Aspirin



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-26

Patient:

Reactions: Malaise, Nonspecific Reaction, Product Tampering, Tremor

Drug(s) suspected as cause:
Miralax
    Dosage: unk unk, unknown
    Administration route: Oral
    Indication: Constipation
    End date: 2012-02-21

Miralax
    Indication: Medical Observation

Other drugs received by patient: Lovaza; Hydrochlorothiazide; Arimidex; Caltrate (Calcium Carbonate (+) Cholecalciferol); Pyridoxine HCL



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient:

Reactions: Incorrect Drug Administration Duration, NO Therapeutic Response

Drug(s) suspected as cause:
Miralax
    Indication: Medical Observation

Miralax
    Dosage: 17 g, qd
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-11-01
    End date: 2012-04-01



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient:

Reactions: Vomiting, Nausea, Headache, Hyperhidrosis, Abdominal Pain Upper, Paraesthesia, Off Label Use, Overdose

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qh
    Administration route: Oral
    Indication: Colonoscopy

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Drug Effect Decreased, Incorrect Drug Administration Duration

Drug(s) suspected as cause:
Miralax
    Indication: Medical Observation

Miralax
    Dosage: unk, qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01



Possible Miralax side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Incorrect Drug Administration Duration, Overdose, Nail Discolouration, Drug Administered To Patient of Inappropriate AGE, Nail Disorder

Drug(s) suspected as cause:
Miralax
    Indication: Medical Observation

Miralax
    Dosage: 17 g, bid
    Administration route: Oral
    Indication: Constipation
    Start date: 2010-01-01



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Cardiac Flutter, Incorrect Drug Administration Duration

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Dysgeusia, Nausea, Rhinorrhoea

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Abdominal Distension

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Off Label Use, Incorrect Drug Administration Duration, Faeces Discoloured

Drug(s) suspected as cause:
Miralax
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Colonoscopy
    Start date: 2012-07-01

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Miralax
    Indication: Medical Observation

Miralax
    Dosage: unk, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Drug Ineffective, Pain, Faecal Incontinence, Faecaloma

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Therapeutic Product Ineffective

Drug(s) suspected as cause:
Miralax
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Constipation

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Incorrect Drug Administration Duration, Urinary Tract Disorder

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Gastritis

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Diarrhoea, Faecal Incontinence, Asthenia, Discomfort

Drug(s) suspected as cause:
Miralax
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Miralax
    Dosage: unk unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Off Label Use, Incorrect Drug Administration Duration, Drug Administered To Patient of Inappropriate AGE

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qd
    Administration route: Oral
    Indication: Constipation Prophylaxis

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Incorrect Drug Administration Duration, Diarrhoea, Underdose

Drug(s) suspected as cause:
Miralax
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Constipation

Miralax
    Indication: Medical Observation

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