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Prometrium (Progesterone Oral) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prometrium (Progesterone Oral) 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 (96)
Death (1)
Disability (2)

Reports by Reaction Type

Vaginal Haemorrhage (11)Off Label Use (10)Headache (9)Anxiety (9)Insomnia (8)Abortion Spontaneous (7)Dizziness (7)Premature Baby (7)Maternal Exposure During Pregnancy (7)Foetal Exposure During Pregnancy (5)Fatigue (5)Breast Cancer (5)

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

Possible Prometrium side effects in female

Reported by a pharmacist from United States on 2012-08-09

Patient: female

Reactions: Speech Disorder, Mental Disorder, Feeling Abnormal, Delirium

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient:

Reactions: Weight Decreased, Foot Operation, Tinea Versicolour, Cyst, Rash Pruritic, Exostosis, Menorrhagia, Migraine, Breast Cancer, Cataract, Nausea, Ovarian Cyst, Hepatic Enzyme Increased, Osteoarthritis, Syncope, Intermittent Claudication, Arthralgia, Bronchial Hyperreactivity, Angiopathy, Asthenia, Ovarian Cancer, Deep Vein Thrombosis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Prometrium
    Indication: Menstruation Irregular
    Start date: 2007-01-01
    End date: 2007-01-01

Nuvaring
    Indication: Contraception
    Start date: 2005-09-25
    End date: 2006-05-01

Nuvaring
    Indication: Menstrual Disorder

Other drugs received by patient: Advair; Singulair; Topamax; Anesthetic (Unspecified)



Possible Prometrium side effects in female

Reported by a physician from United States on 2012-06-29

Patient: female

Reactions: Retinal Vascular Thrombosis

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-25

Patient: female

Reactions: Palpitations, Tremor

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: female

Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Abnormal Behaviour, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2001-01-01
    End date: 2007-01-01

Prometrium
    Indication: Foetal Exposure During Pregnancy

Nifedipine
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Lithium Carbonate
    Indication: Foetal Exposure During Pregnancy

Clindamycin
    Indication: Foetal Exposure During Pregnancy

Lexapro
    Indication: Foetal Exposure During Pregnancy

Zithromax
    Indication: Foetal Exposure During Pregnancy

Betamethasone
    Indication: Foetal Exposure During Pregnancy

Ampicillin
    Indication: Foetal Exposure During Pregnancy



Possible Prometrium side effects in female

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

Patient: female

Reactions: Emotional Distress, Chorioamnionitis, Bipolar Disorder, Maternal Exposure During Pregnancy, Premature Delivery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexapro
    Administration route: Oral
    Indication: Bipolar Disorder

Zithromax
    Indication: Product Used FOR Unknown Indication

Prometrium
    Administration route: Oral
    Indication: Pregnancy

Topamax
    Administration route: Oral
    Indication: Anxiety
    Start date: 2001-01-01
    End date: 2007-01-01

Lithium Carbonate
    Administration route: Oral
    Indication: Bipolar Disorder

Betamethasone
    Indication: Product Used FOR Unknown Indication

Clindamycin
    Indication: Bacterial Infection

Topamax
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2001-01-01
    End date: 2007-01-01

Nifedipine
    Indication: Product Used FOR Unknown Indication

Ampicillin
    Indication: Product Used FOR Unknown Indication

Terbutaline
    Administration route: Oral
    Indication: Premature Labour



Possible Prometrium side effects in 57 year old female

Reported by a pharmacist from Canada on 2012-06-05

Patient: 57 year old female

Reactions: Drug Interaction, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient possibly interacting with the suspect drug:
Methotrexate Sodium
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Estrace
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-09

Other drugs received by patient: Budesonide; Synthroid; Cefzil; Folic Acid; Chlortripolon; Triatec-30



Possible Prometrium side effects in

Reported by a physician from United States on 2012-06-04

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Heart Valve Disorder

Drug(s) suspected as cause:
Prometrium
    Indication: Maternal Exposure Timing Unspecified

Lupron Depot
    Indication: Maternal Exposure Timing Unspecified



Possible Prometrium side effects in male

Reported by a physician from Greece on 2012-06-04

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Folic Acid
    Indication: Maternal Exposure Timing Unspecified

Prometrium
    Indication: Maternal Exposure Timing Unspecified

Vitamin B Complex CAP
    Indication: Maternal Exposure Timing Unspecified

Paricalcitol
    Indication: Maternal Exposure Timing Unspecified



Possible Prometrium side effects in 36 year old female

Reported by a physician from Greece on 2012-06-04

Patient: 36 year old female

Reactions: Off Label Use, Premature Rupture of Membranes, Caesarean Section, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Calcium Carbonate; Paricalcitol; Vitamin B Complex CAP; Darbepoetin Alfa; Tinzaparin; Levocarnitine; Iron Sucrose; Sevelamer Hydrochloride; Tinzaparin; Folic Acid



Possible Prometrium side effects in male

Reported by a physician from Greece on 2012-06-04

Patient: male, weighing 2.1 kg (4.6 pounds)

Reactions: Caesarean Section, Premature Baby, Foetal Exposure During Pregnancy, Gastroenteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paricalcitol
    Indication: Maternal Exposure Timing Unspecified

Folic Acid
    Indication: Maternal Exposure Timing Unspecified

Prometrium
    Indication: Maternal Exposure Timing Unspecified

Vitamin B Complex CAP
    Indication: Maternal Exposure Timing Unspecified



Possible Prometrium side effects in female

Reported by a physician from United States on 2012-06-04

Patient: female

Reactions: Proteinuria, PRE-Eclampsia

Drug(s) suspected as cause:
Prometrium
    Indication: Product Used FOR Unknown Indication

Lupron Depot
    Indication: Endometriosis

Other drugs received by patient: Fioricet; Multi-Vitamins



Possible Prometrium side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-01

Patient: 35 year old female

Reactions: Movement Disorder, Hypotension, Sensation of Heaviness, Blood Glucose Abnormal, Dysarthria, Hypotonia, Dizziness, Asthenia, Bradyphrenia

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Extra Strength Tylenol; Betahistine; Multi-Vitamins



Possible Prometrium side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-30

Patient: 36 year old female

Reactions: Off Label Use, Abortion Spontaneous

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

Prometrium
    Indication: Product Used FOR Unknown Indication



Possible Prometrium side effects in

Reported by a physician from United States on 2012-05-15

Patient:

Reactions: Rash, Withdrawal Bleed

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in 38 year old female

Reported by a pharmacist from United States on 2012-05-15

Patient: 38 year old female

Reactions: Dysphagia, Wrong Technique in Drug Usage Process, Choking

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female, weighing 49.9 kg (109.9 pounds)

Reactions: Off Label Use, Asthma, Hypersensitivity, Urticaria, Headache, Upper Respiratory Tract Congestion

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female, weighing 113.5 kg (249.7 pounds)

Reactions: Drug Prescribing Error, Drug Dispensing Error, Contraindication To Medical Treatment

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Methyldopa; Metformin HCL; Hydorchlorothiazide; Levoxyl



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female, weighing 88.5 kg (194.8 pounds)

Reactions: Drug Dose Omission, Headache, Vaginal Haemorrhage

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Propranolol; Myland; Estradiol; Spironolactone



Possible Prometrium side effects in female

Reported by a physician on 2012-05-15

Patient: female

Reactions: Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female

Reactions: Capsule Physical Issue, Depressed Mood, Incorrect Storage of Drug, Vaginal Haemorrhage

Drug(s) suspected as cause:
Vivelle-DOT
    Indication: Oestrogen Therapy

Prometrium
    Indication: Product Used FOR Unknown Indication



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female

Reactions: Visual Impairment

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 64 year old male, weighing 77.2 kg (169.8 pounds)

Reactions: Wrong Drug Administered

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Plavix; Aspirin; Advair Diskus 100 / 50; Zestril; Combivent; Lovaza



Possible Prometrium side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 55 year old female

Reactions: Anxiety, Fatigue, Headache, Nervousness, Menopausal Symptoms

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a pharmacist from United States on 2012-05-15

Patient: female

Reactions: Off Label Use, Pruritus, Food Allergy, Urticaria, Eye Swelling, Infertility

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Testosterone
    Indication: Product Used FOR Unknown Indication

Prometrium
    Indication: Product Used FOR Unknown Indication



Possible Prometrium side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 39 year old female, weighing 63.6 kg (139.8 pounds)

Reactions: Off Label Use, Thinking Abnormal, Fatigue

Drug(s) suspected as cause:
Prometrium
    Indication: Antioestrogen Therapy

Prometrium
    Dosage: take on days 11-28 of cycle at bedtime
    Indication: Endometriosis
    Start date: 2012-04-06

Other drugs received by patient: Thyroid TAB



Possible Prometrium side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 39 year old female

Reactions: Off Label Use, Flatulence, Abdominal Distension

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female

Reactions: Drug Effect Decreased, Insomnia, Product Physical Issue

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female

Reactions: Therapeutic Response Unexpected, Inflammation

Drug(s) suspected as cause:
Prometrium

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