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Scopolamine (Scopolamine) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (20)

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

Possible Scopolamine side effects in male

Reported by a pharmacist from Denmark on 2012-07-24

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Off Label Use, Swollen Tongue

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Acetaminophen



Possible Scopolamine side effects in male

Reported by a pharmacist from Ireland on 2012-07-24

Patient: male

Reactions: Off Label Use, Therapeutic Response Unexpected, Application Site Hypersensitivity

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Nexium; Amlodipine Besylate; Mirtazapine; Lioresal; Losartan Potassium; Zolpidem Tatrate; Cetirizine HCL; Proscar; Galfer; Senokot / UNK /; Citalopram Hydrobromide; Solpadeine / IRE /; Lactulose



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-07-10

Patient: female, weighing 89.0 kg (195.8 pounds)

Reactions: Weight Increased, Off Label Use, Sedation, Obesity, Tachycardia, Constipation, Faecaloma

Drug(s) suspected as cause:
Clozaril
    Dosage: 75mg in morning and 100mg in evening

Clozaril
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2010-07-01

Clozaril
    Dosage: 50 mg, bid

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2010-09-01

Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Diazepam; Valproic Acid



Possible Scopolamine side effects in female

Reported by a physician from United Kingdom on 2012-07-10

Patient: female, weighing 89.0 kg (195.8 pounds)

Reactions: Off Label Use, Weight Increased, Sedation, Obesity, Tachycardia, Constipation, Faecaloma

Drug(s) suspected as cause:
Clozaril
    Dosage: 50 mg, bid

Clozaril
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2010-07-01

Clozaril
    Dosage: 75mg in morning and 100mg in evening

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2010-09-01

Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Valproic Acid; Diazepam



Possible Scopolamine side effects in 85 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-07-03

Patient: 85 year old male

Reactions: Incoherent, Off Label Use, Urinary Tract Infection, Coordination Abnormal, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-02

Patient: female

Reactions: Confusional State, Off Label Use, Speech Disorder, Mydriasis, Erythema, Altered State of Consciousness

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in male

Reported by a pharmacist from Denmark on 2012-06-22

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Off Label Use, Swollen Tongue

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in female

Reported by a physician from United Kingdom on 2012-06-19

Patient: female, weighing 89.0 kg (195.8 pounds)

Reactions: Off Label Use, Weight Increased, Tachycardia, Sedation, Obesity, Constipation, Faecaloma

Drug(s) suspected as cause:
Clozaril
    Dosage: 50 mg, bid

Clozaril
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2010-08-25

Clozaril
    Dosage: 75mg in morning and 100mg in evening

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2010-09-01

Other drugs received by patient: Diazepam; Procyclidine Hydrochloride 2MG TAB; Valproic Acid



Possible Scopolamine side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-19

Patient: female, weighing 89.0 kg (195.8 pounds)

Reactions: Weight Increased, Off Label Use, Tachycardia, Obesity, Sedation, Constipation, Faecaloma

Drug(s) suspected as cause:
Clozaril
    Dosage: 50 mg, bid

Clozaril
    Dosage: 75mg in morning and 100mg in evening

Clozaril
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2010-08-25

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2010-09-01

Other drugs received by patient: Valproic Acid; Diazepam; Procyclidine Hydrochloride 2MG TAB



Possible Scopolamine side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-07

Patient: 69 year old male

Reactions: Off Label Use, Unresponsive To Stimuli, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Haloperidol; Aspirin; Lidocaine; Bisoprolol Fumarate; Furosemide; Oxycodone HCL; Gabapentin



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from NEW Zealand on 2012-02-06

Patient: female

Reactions: Dysgeusia, Off Label Use, Dysphagia, Pharyngeal Oedema, Oedema Mouth, Vocal Cord Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in 11 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-25

Patient: 11 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Off Label Use, Diplopia, Nightmare, Hallucination, Auditory, Incorrect Dose Administered, Hallucination, Nervousness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Acetaminophen



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from France on 2012-01-20

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Abasia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in female

Reported by a pharmacist from France on 2012-01-16

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Abasia, Incorrect Dose Administered

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in 15 year old

Reported by a pharmacist from Norway on 2011-12-23

Patient: 15 year old

Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Diplopia, Headache

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Start date: 2011-12-11

Scopolamine
    Dosage: 1 df, q72h
    Indication: Nausea
    Start date: 2011-12-07
    End date: 2011-12-11

Other drugs received by patient: Ondansetron; Medrol; Acetaminophen; Ibuprofen; Esomeprazole Magnesium



Possible Scopolamine side effects in 15 year old

Reported by a pharmacist from Norway on 2011-12-20

Patient: 15 year old

Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Diplopia, Headache

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Start date: 2011-12-11

Scopolamine
    Dosage: 1 df, q72h
    Indication: Nausea
    Start date: 2011-12-07
    End date: 2011-12-11

Other drugs received by patient: Medrol; Acetaminophen; Ibuprofen; Esomeprazole; Ondansetron



Possible Scopolamine side effects in 76 year old female

Reported by a consumer/non-health professional from Germany on 2011-11-04

Patient: 76 year old female

Reactions: Off Label Use, Vomiting, Nausea, Urinary Retention

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in 16 year old male

Reported by a physician from United Kingdom on 2011-10-27

Patient: 16 year old male, weighing 28.0 kg (61.6 pounds)

Reactions: Incorrect Route of Drug Administration, Vomiting, Wrong Technique in Drug Usage Process, Pruritus, Dyskinesia, Eructation, Food Aversion, Off Label Use, Rash Erythematous, Application Site Irritation, Hypersomnia

Drug(s) suspected as cause:
Metoclopramide
    Dosage: 5 to 10mg, prn
    Indication: Vomiting
    Start date: 2011-09-05

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2011-05-16
    End date: 2011-09-16

Scopolamine
    Dosage: unk, unk
    Start date: 2002-01-01
    End date: 2002-01-01

Scopolamine
    Administration route: Oral
    Start date: 2011-09-16
    End date: 2011-09-16



Possible Scopolamine side effects in male

Reported by a consumer/non-health professional from Germany on 2011-10-25

Patient: male

Reactions: Wrong Technique in Drug Usage Process, Paresis, Extrasystoles, Quality of Life Decreased, Pallor, Somnolence, Death, Poor Quality Sleep, Off Label Use, Fatigue, Oedema Peripheral, Respiratory Muscle Weakness, Sudden Onset of Sleep, Oxygen Saturation Decreased, Motor Dysfunction, General Physical Health Deterioration, Cognitive Disorder, Anxiety, Hypopnoea, Depressed Level of Consciousness, Mobility Decreased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Scopolamine
    Dosage: 0.25 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2011-03-15

Scopolamine
    Dosage: 0.5 df, q72h
    Start date: 2011-03-14
    End date: 2011-03-14

Other drugs received by patient: Metoprolol Succinate; Levothyroxine Sodium; NON-Drug: Bandages



Possible Scopolamine side effects in male

Reported by a pharmacist from United Kingdom on 2011-10-19

Patient: male, weighing 28.0 kg (61.6 pounds)

Reactions: Incorrect Route of Drug Administration, Pruritus, Wrong Technique in Drug Usage Process, Vomiting, Dyskinesia, Eructation, Food Aversion, Off Label Use, Rash Erythematous, Hypersomnia, Application Site Irritation

Drug(s) suspected as cause:
Metoclopramide
    Dosage: 5 to 10mg, prn
    Indication: Vomiting
    Start date: 2011-09-05

Scopolamine
    Dosage: unk, unk
    Start date: 2002-01-01
    End date: 2002-01-01

Scopolamine
    Dosage: 1 df, q72h
    Indication: Salivary Hypersecretion
    Start date: 2011-05-16
    End date: 2011-09-16

Scopolamine
    Administration route: Oral
    Start date: 2011-09-16
    End date: 2011-09-16

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