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Miralax (Polyethylene Glycol 3350) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (22)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Miralax (Polyethylene Glycol 3350) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

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 2012-08-25

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: Off Label Use, Pain, Underdose, Eructation

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

Miralax
    Indication: Bowel Preparation

Other drugs received by patient: Aspirin



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: 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 2012-08-23

Patient:

Reactions: Off Label Use, Overdose

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Off Label Use, Vomiting, Overdose

Drug(s) suspected as cause:
Miralax
    Dosage: 255 g, once
    Administration route: Oral
    Indication: Bowel Preparation
    Start date: 2012-07-25

Miralax
    Indication: Colonoscopy



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Off Label Use, Overdose, Diarrhoea, Abnormal Faeces

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

Miralax
    Dosage: 119 g, once
    Administration route: Oral
    Indication: Colonoscopy



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Off Label Use, Overdose, Drug Ineffective, Drug Administered To Patient of Inappropriate AGE

Drug(s) suspected as cause:
Miralax
    Dosage: 17 g, qid
    Administration route: Oral
    Indication: Constipation
    Start date: 2012-07-03

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient:

Reactions: Off Label Use, Incorrect Drug Administration Duration, Glossodynia, Foreign Body

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

Miralax
    Indication: Polyp

Miralax
    Dosage: 17 g, qd
    Administration route: Oral
    Indication: Functional Gastrointestinal Disorder
    Start date: 2009-01-01



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Off Label Use, Overdose, 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 2012-08-07

Patient:

Reactions: Off Label Use, Overdose

Drug(s) suspected as cause:
Miralax
    Dosage: 17 g, tid
    Administration route: Oral
    Indication: Medical Observation
    Start date: 2012-05-30

Miralax
    Indication: Colonoscopy



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Off Label Use, Frequent Bowel Movements, Drug Administered To Patient of Inappropriate AGE

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

Miralax
    Dosage: 17 g, unknown
    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 2012-08-06

Patient:

Reactions: Off Label Use, Overdose, Wrong Technique in Drug Usage Process, Nausea, Drug Effect Increased, Blood Electrolytes Decreased

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

Miralax
    Dosage: unk unk, unknown
    Administration route: Oral
    Indication: Colonoscopy
    Start date: 2012-04-24
    End date: 2012-04-25

Other drugs received by patient: ONE-A-DAY Essential Vitamins; Iron (Unspecified); Kelp; Calcium (Unspecified) (+) Vitamin D (Unspecified); Xanthophyll



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Off Label Use, Swelling Face

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Dysgeusia, Off Label Use, 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 2012-07-26

Patient:

Reactions: Off Label Use, Incorrect Storage of Drug

Drug(s) suspected as cause:
Miralax



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient:

Reactions: Off Label Use, Nasopharyngitis, Drug Administered To Patient of Inappropriate AGE, Blood Glucose Increased

Drug(s) suspected as cause:
Miralax
    Dosage: unk, qam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-21

Miralax
    Indication: Medical Observation



Possible Miralax side effects in

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient:

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

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

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



Possible Miralax side effects in male

Reported by a physician from United States on 2011-12-23

Patient: male

Reactions: Somnolence, Off Label Use, Haematocrit Decreased, Fatigue, Aspiration, Dizziness, Hypoxia, Vomiting, Alanine Aminotransferase Increased, Sensation of Heaviness, Muscular Weakness, Toxicity To Various Agents, Haemoglobin Decreased, Diarrhoea, Blood Potassium Decreased, Hypophagia, Dehydration, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: unk
    Indication: Oropharyngeal Cancer Recurrent

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Oropharyngeal Cancer Recurrent
    Start date: 2011-10-12

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    End date: 2011-10-28

External Beam Radiation Therapy
    Dosage: weekly, ex. beam
    Indication: Oropharyngeal Cancer Recurrent
    Start date: 2011-10-13

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

Other drugs received by patient: Glimepiride; Lidoderm; Oxycodone HCL; Ativan; Folic Acid; Levothyroxine Sodium; Colace; Ativan; Neurontin; Ambien; Duragesic-100; Prochlorperazine Maleate; Zofran; Proair HFA



Possible Miralax side effects in male

Reported by a physician from United States on 2011-12-12

Patient: male

Reactions: Vomiting, Alanine Aminotransferase Increased, Febrile Neutropenia, Muscular Weakness, Off Label Use, Fatigue, Diarrhoea, Aspiration, Dehydration, Hypophagia, Aspartate Aminotransferase Increased, Hypoxia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alimta
    Dosage: unk
    Indication: Oropharyngeal Cancer Recurrent

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    End date: 2011-10-28

Erlotinib Hydrochloride
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Oropharyngeal Cancer Recurrent
    Start date: 2011-10-12

External Beam Radiation Therapy
    Dosage: weekly, ex. beam
    Indication: Oropharyngeal Cancer Recurrent
    Start date: 2011-10-13

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

Other drugs received by patient: Colace; Folic Acid; Oxycodone HCL; Ativan; Levothyroxine Sodium; Glimepiride; Zofran; Proair HFA; Neurontin; Prochlorperazine Maleate; Ambien; Lidoderm; Ativan; Duragesic-100

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