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Scopolamine (Scopolamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Scopolamine 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 (104)
Death (12)
Life Threatening Events (4)
Disability (5)

Reports by Reaction Type

Off Label Use (20)Vomiting (16)Confusional State (13)Hallucination (13)Abdominal Pain (11)Dyskinesia (10)Pain (10)Nausea (10)DRY Mouth (9)Weight Decreased (8)Dizziness (8)Anaemia (8)

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

Possible Scopolamine side effects in female

Reported by a physician from Germany on 2012-08-27

Patient: female, weighing 70.7 kg (155.5 pounds)

Reactions: Bedridden, Vomiting, Nausea, Tremor, Renal Impairment, Visual Impairment, DRY Mouth, Dizziness, Cardiovascular Disorder, Blood Pressure Fluctuation, Asthenia

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Haematuria, Anaemia, Rectal Haemorrhage, Duodenal Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Dosage: 1df= 1dose
    Administration route: Oral
    Indication: Factor V Leiden Mutation
    Start date: 2008-01-01
    End date: 2012-07-28

Ibuprofen
    Dosage: 1df= 1dose
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Scopolamine
    Dosage: buscopan 20 mg/ml. 1df=1 dose
    Indication: Abdominal Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Other drugs received by patient: Allopurinol; Pentacol



Possible Scopolamine side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-21

Patient: male

Reactions: Haematuria, Anaemia, Rectal Haemorrhage, Duodenal Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coumadin
    Administration route: Oral
    Indication: Factor V Leiden Mutation
    Start date: 2008-01-01
    End date: 2012-07-28

Ibuprofen
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Scopolamine
    Indication: Abdominal Pain
    Start date: 2012-07-21
    End date: 2012-07-28

Other drugs received by patient: TPN



Possible Scopolamine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-10

Patient: 38 year old female

Reactions: Oligohydramnios, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Acetaminophen
    Indication: Renal Colic

Diazepam
    Indication: Renal Colic

Diclofenac Sodium
    Dosage: 6 doses
    Indication: Renal Colic

Dipyrone TAB
    Indication: Renal Colic

Meperidine HCL
    Indication: Renal Colic

Scopolamine
    Indication: Renal Colic



Possible Scopolamine side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-25

Patient: 38 year old female

Reactions: Dysmenorrhoea, Haemorrhage, Purpura, Platelet Aggregation Abnormal

Drug(s) suspected as cause:
Scopolamine
    Indication: Dysmenorrhoea

Voltaren
    Dosage: 75 mg daily
    Administration route: Oral
    Indication: Dysmenorrhoea
    End date: 2011-07-05

Other drugs received by patient: Leuprolide Acetate; Loxonin



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 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 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 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-06

Patient: 66 year old male

Reactions: Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Actiskenan
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 2009-02-17
    End date: 2009-05-12

Duragesic-100
    Dosage: 1 df, 1x/day
    Start date: 2009-04-14
    End date: 2009-05-12

Hydroxyzine HCL
    Dosage: 1 df, 1x/day
    Indication: Insomnia
    Start date: 2009-04-13
    End date: 2009-05-12

Nexium
    Dosage: 40 mg, 1x/day
    Indication: Oesophagitis
    Start date: 2009-04-13
    End date: 2009-04-20

Paroxetine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-12
    End date: 2009-05-12

Scopolamine
    Dosage: unk
    Start date: 2009-03-06
    End date: 2009-05-12

Solu-Medrol
    Dosage: 1 df, 1x/day
    Indication: Decreased Appetite
    Start date: 2009-04-13
    End date: 2009-05-12

Other drugs received by patient: Therapeutic Radiopharmaceuticals



Possible Scopolamine side effects in 77 year old male

Reported by a pharmacist from United States on 2012-07-05

Patient: 77 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Confusional State, Psychomotor Hyperactivity, Post Procedural Complication, Abnormal Behaviour, Delirium, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Thiamine; Amlodipine; Enoxaparin; Ferrous Sulfate TAB; Terazosin HCL; Warfarin Sodium; Acetaminophen / Hydrocodone Bitartrate; Senna / Docusate; Oxycodone HCL; Pantoprazole; Atenolol; Zolpidem



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 physician from Netherlands on 2012-07-03

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Agitation, Confusional State, Abnormal Behaviour, Atrial Fibrillation, Delirium, Fall, Dysarthria, Anger, Coordination Abnormal, Transient Ischaemic Attack, Hallucination

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Start date: 2012-06-02
    End date: 2012-06-03

Scopolamine
    Dosage: 1 df, once/single
    Indication: Motion Sickness
    Start date: 2012-05-29

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Start date: 2012-05-27
    End date: 2012-06-03

Other drugs received by patient: Calcium Carbonate W / Calcium Gluconate; Prolia; Ebastine; Hydrochlorothiazide; Metoprolol Succinate



Possible Scopolamine side effects in female

Reported by a physician from Netherlands on 2012-07-03

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Agitation, Atrial Fibrillation, Abnormal Behaviour, Fall, Delirium, Dysarthria, Anger, Coordination Abnormal, Transient Ischaemic Attack, Hallucination

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Start date: 2012-06-02
    End date: 2012-06-03

Scopolamine
    Dosage: 1 df, once/single
    Indication: Motion Sickness
    Start date: 2012-05-29

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Start date: 2012-05-27
    End date: 2012-06-03

Other drugs received by patient: Prolia; Calcium Carbonate W / Calcium Gluconate; Metoprolol Succinate; Hydrochlorothiazide; Ebastine



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 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-26

Patient: 66 year old male

Reactions: Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Duragesic-100
    Dosage: 1 df, 1x/day
    Start date: 2009-04-14
    End date: 2009-05-12

Hydroxyzine HCL
    Dosage: 1 df, 1x/day
    Indication: Insomnia
    Start date: 2009-04-13
    End date: 2009-05-12

Morphine Sulfate
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 2009-02-17
    End date: 2009-05-12

Nexium
    Dosage: 40 mg, 1x/day
    Indication: Oesophagitis
    Start date: 2009-04-13
    End date: 2009-04-20

Paroxetine HCL
    Dosage: unk
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-12
    End date: 2009-05-12

Scopolamine
    Dosage: unk
    Start date: 2009-03-06
    End date: 2009-05-12

Solu-Medrol
    Dosage: 1 df, 1x/day
    Indication: Decreased Appetite
    Start date: 2009-04-13
    End date: 2009-05-12

Other drugs received by patient: Therapeutic Radiopharmaceuticals



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Augmentin '125'
    Dosage: unk

Benadryl
    Dosage: 2% spray

Butorphanol
    Dosage: unk

Celebrex
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Clindamycin HCL
    Dosage: unk

Cyproheptadine HCL
    Dosage: unk

Dihydroergotamine Mesylate
    Dosage: unk

Doxycycline Monohydrate
    Dosage: unk

Frova
    Dosage: unk

Keflex
    Dosage: unk

Ketorolac Tromethamine
    Dosage: unk

Lidocaine Hydrochloride
    Dosage: unk

Lovenox
    Dosage: unk

Lyrica
    Dosage: unk

Naproxen
    Dosage: unk

Prochlorperazine
    Dosage: unk

Reglan
    Dosage: unk

Scopolamine
    Dosage: unk

Skelaxin
    Dosage: unk

Talwin
    Dosage: unk

Tramadol HCL
    Dosage: unk

Valium
    Dosage: unk

Zomig
    Dosage: unk



Possible Scopolamine side effects in male

Reported by a physician from France on 2012-06-22

Patient: male

Reactions: Anaemia, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 100mg/2ml
    Indication: Insomnia
    Start date: 2009-04-13

Duragesic-100
    Dosage: 1 patch daily
    Administration route: Topical
    Start date: 2009-04-14

Morphine Sulfate
    Administration route: Oral
    Start date: 2009-02-17

Nexium
    Indication: Oesophagitis
    Start date: 2009-04-13
    End date: 2009-04-20

Paroxetine HCL
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-12

Scopolamine
    Administration route: Topical
    Start date: 2009-03-06

Solu-Medrol
    Dosage: 40mg/2ml
    Indication: Decreased Appetite
    Start date: 2009-04-13

Other drugs received by patient: Radiotherapy



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 France on 2012-06-21

Patient: female

Reactions: Confusional State, Agitation, Retrograde Amnesia, Incorrect Dose Administered, Disorientation, Headache, Disinhibition, Balance Disorder, Vertigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Scopolamine

Other drugs received by patient: Practazin; Levothyroxine Sodium



Possible Scopolamine side effects in male

Reported by a physician from France on 2012-06-21

Patient: male

Reactions: Anaemia, Malnutrition, Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Atarax
    Dosage: 1 df, qd
    Indication: Insomnia
    Start date: 2009-04-13
    End date: 2009-05-12

Duragesic-100
    Dosage: 1 df, qd
    Start date: 2009-04-14
    End date: 2009-05-12

Morphine Sulfate
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2009-02-17

Nexium
    Dosage: 40 mg, qd
    Indication: Oesophagitis
    Start date: 2009-04-13
    End date: 2009-04-20

Paroxetine HCL
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-12
    End date: 2009-05-12

Scopolamine
    Dosage: unk
    Start date: 2009-03-06

Solu-Medrol
    Dosage: 1 df, qd
    Indication: Decreased Appetite
    Start date: 2009-04-13
    End date: 2009-05-12



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-06-20

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Agitation, Atrial Fibrillation, Fall, Dysarthria, Anger, Coordination Abnormal, Hallucination, Transient Ischaemic Attack

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Indication: Motion Sickness
    Start date: 2012-05-27

Scopolamine
    Dosage: 1 df, unk
    Start date: 2012-06-02
    End date: 2012-06-03

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Start date: 2012-05-27
    End date: 2012-06-03

Other drugs received by patient: Ebastine; Prolia; Calcium ^sandoz^; Hydrochlorothiazide; Metoprolol Succinate



Possible Scopolamine side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-06-20

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Agitation, Confusional State, Atrial Fibrillation, Fall, Dysarthria, Anger, Coordination Abnormal, Hallucination, Transient Ischaemic Attack

Drug(s) suspected as cause:
Scopolamine
    Dosage: 1 df, unk
    Indication: Motion Sickness
    Start date: 2012-05-27

Scopolamine
    Dosage: 1 df, unk
    Start date: 2012-06-02
    End date: 2012-06-03

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Start date: 2012-05-27
    End date: 2012-06-03

Other drugs received by patient: Ebastine; Calcium ^sandoz^; Prolia; Hydrochlorothiazide; Metoprolol Succinate



Possible Scopolamine side effects in male

Reported by a physician from France on 2012-06-20

Patient: male

Reactions: Anaemia, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atarax
    Dosage: 100mg per day
    Indication: Insomnia
    Start date: 2009-04-13
    End date: 2009-05-12

Duragesic-100
    Dosage: 1unit per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-14
    End date: 2009-05-12

Morphine Sulfate
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-17
    End date: 2009-05-12

Nexium
    Dosage: 40mg per day
    Indication: Oesophagitis
    Start date: 2009-04-13
    End date: 2009-04-20

Paroxetine HCL
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-12
    End date: 2009-05-12

Scopolamine
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-03-06
    End date: 2009-05-12

Solu-Medrol
    Dosage: 40mg per day
    Indication: Decreased Appetite
    Start date: 2009-04-13
    End date: 2009-05-12

Other drugs received by patient: Radiotherapy



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 female

Reported by a consumer/non-health professional from Germany on 2012-06-13

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Bedridden, Vomiting, Nausea, Tremor, Renal Impairment, Visual Impairment, DRY Mouth, Dizziness, Blood Pressure Fluctuation, Cardiovascular Disorder, Asthenia

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-22

Patient: 75 year old female, weighing 53.3 kg (117.3 pounds)

Reactions: Nausea, Anaemia, Rash, Pyrexia, Haematotoxicity, Agranulocytosis, Gastrointestinal Disorder, Diarrhoea Haemorrhagic, Bone Marrow Failure, Blood Pressure Abnormal, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flumazenil
    Dosage: unk

Imatinib Mesylate
    Dosage: 100 mg, daily 3 times per week
    Administration route: Oral
    Start date: 2007-10-01
    End date: 2007-11-01

Imatinib Mesylate
    Dosage: 400 mg, daily, 3 times per week
    Administration route: Oral
    Start date: 2007-11-01

Imatinib Mesylate
    Dosage: 400 mg, daily, 3 times per week
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2001-12-01

Scopolamine
    Dosage: unk



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from Germany on 2012-05-22

Patient: female

Reactions: Vomiting, Nausea, Visual Impairment, DRY Mouth, Cardiovascular Disorder, Blood Pressure Fluctuation

Drug(s) suspected as cause:
Scopolamine



Possible Scopolamine side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-05-14

Patient: female

Reactions: Application Site Pain, Thermal Burn, Wound Secretion

Drug(s) suspected as cause:
Scopolamine
    Dosage: unk, unk
    Start date: 2012-01-06
    End date: 2012-01-06

Scopolamine
    Dosage: unk, unk
    Indication: Motion Sickness
    Start date: 2011-11-01
    End date: 2011-11-01

Other drugs received by patient: Bendroflumethiazide; Alendronic Acid

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