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Synarel (Nafarelin Nasal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Synarel (Nafarelin Nasal) 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 (17)

Reports by Reaction Type

Respiratory Distress (3)Cerebral Infarction (3)Uterine Haemorrhage (3)Endometrial Hyperplasia (2)Vascular Dissection (2)Visual Impairment (2)Endometrial Atrophy (2)Drug Ineffective (1)Osteoporosis (1)Pain (1)Visual Acuity Reduced (1)Weight Increased (1)

Possible Synarel side effects in 31 year old female

Reported by a physician from Sweden on 2012-07-19

Patient: 31 year old female

Reactions: Visual Acuity Reduced

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 37 year old female

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

Patient: 37 year old female

Reactions: Endometrial Hyperplasia, Uterine Haemorrhage, Endometrial Atrophy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 37 year old female

Reported by a physician from Bulgaria on 2012-06-27

Patient: 37 year old female

Reactions: Endometrial Hyperplasia, Endometrial Atrophy, Uterine Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-22

Patient: 34 year old female

Reactions: Cerebral Infarction, Ischaemic Stroke, Carotid Artery Dissection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Puregon (Follitropin Beta / 01348901 / )
    Dosage: sc
    Indication: Endometriosis
    Start date: 2009-01-01
    End date: 2009-05-01

Synarel
    Dosage: nas
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01
    End date: 2009-01-01



Possible Synarel side effects in 37 year old

Reported by a physician from Bulgaria on 2012-06-12

Patient: 37 year old

Reactions: Uterine Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-05-25

Patient: 34 year old female

Reactions: Cerebral Infarction, Vascular Dissection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Puregon (Follitropin Beta / 01348901 / )
    Dosage: sc
    Indication: Endometriosis
    Start date: 2009-01-01
    End date: 2009-05-01

Synarel
    Dosage: nas
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01
    End date: 2009-01-01



Possible Synarel side effects in 34 year old female

Reported by a physician from Sweden on 2012-05-23

Patient: 34 year old female

Reactions: Cerebral Infarction, Vascular Dissection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Puregon
    Dosage: 0.8 ml (900ie/1.08ml)
    Start date: 2009-01-01
    End date: 2009-01-01

Synarel
    Dosage: 200 ug, unk
    Start date: 2009-01-01
    End date: 2009-01-01



Possible Synarel side effects in

Reported by a physician from Sweden on 2012-05-08

Patient:

Reactions: Visual Impairment

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in

Reported by a physician from Sweden on 2012-05-07

Patient:

Reactions: Visual Impairment

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 35 year old female

Reported by a physician from Finland on 2012-04-04

Patient: 35 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Hypoacusis, Drug Ineffective

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 33 year old female

Reported by a consumer/non-health professional from Spain on 2012-03-23

Patient: 33 year old female

Reactions: Amnesia

Drug(s) suspected as cause:
Synarel
    Dosage: 1 inhalation in the morning and 1 inhalation in the afternoon
    Start date: 2012-03-15

Synarel
    Dosage: 2 inhalations in the morning and 2 inhalations in the afternoon
    Indication: Assisted Fertilisation
    Start date: 2012-03-02



Possible Synarel side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-17

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Weight Increased

Drug(s) suspected as cause:
Depo-Provera
    Dosage: unk
    Indication: Menorrhagia
    Start date: 2011-01-01

Synarel
    Dosage: unk
    Indication: Dysmenorrhoea
    Start date: 2006-01-01
    End date: 2011-01-01

Other drugs received by patient: Warfarin Sodium



Possible Synarel side effects in 44 year old female

Reported by a pharmacist from Sweden on 2012-01-30

Patient: 44 year old female

Reactions: Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 44 year old female

Reported by a pharmacist from Sweden on 2011-12-27

Patient: 44 year old female

Reactions: Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 44 year old female

Reported by a pharmacist from Sweden on 2011-12-06

Patient: 44 year old female

Reactions: Respiratory Distress

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 22 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Bone Loss, Osteoporosis, Multiple Fractures

Drug(s) suspected as cause:
Synarel



Possible Synarel side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 36 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Fatigue, Pain, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synarel

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