This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prometrium (Progesterone) 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). 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 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
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 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 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
Possible Prometrium side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female
Reactions: Amenorrhoea
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 54.5 kg (119.9 pounds)
Reactions: Incorrect Dose Administered
Drug(s) suspected as cause:
Prometrium
Start date: 2011-09-29
Prometrium
Indication: Supplementation Therapy
Start date: 2011-08-27
End date: 2011-09-28
Other drugs received by patient: Estradiol; Levothyroxine Sodium; Crinone
Possible Prometrium side effects in male
Reported by a pharmacist from United States on 2012-05-15
Patient: male
Reactions: Wrong Drug Administered, Drug Dispensing Error
Drug(s) suspected as cause:
Prometrium
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Provigil
Indication: Product Used FOR Unknown Indication
Possible Prometrium side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: 46 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Palpitations, Hyperhidrosis
Drug(s) suspected as cause:
Prometrium
Dosage: ten days each month
Start date: 2011-09-14
End date: 2011-09-18
Prometrium
Dosage: for ten days a month each month
Indication: Hormone Therapy
Start date: 1995-01-01
End date: 2011-01-01
Possible Prometrium side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female
Reactions: Drug Interaction, Vaginal Haemorrhage
Drug(s) suspected as cause:
Prometrium
Other drugs received by patient possibly interacting with the suspect drug: Fluconazole
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-01
End date: 2011-11-01
Possible Prometrium side effects in female
Reported by a physician from Greece on 2012-05-15
Patient: female
Reactions: Off Label Use, Caesarean Section, Premature Rupture of Membranes, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Folic Acid
Indication: Product Used FOR Unknown Indication
Vitamin B Complex CAP
Indication: Product Used FOR Unknown Indication
Paricalcitol
Indication: Product Used FOR Unknown Indication
Prometrium
Dosage: start at 22 weeks of pregnancy
Indication: Prophylaxis of Abortion
Other drugs received by patient: Darbepoetin Alfa; Sevelamer Hydrochloride; Levocarnitine
Possible Prometrium side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female
Reactions: General Symptom
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 54.5 kg (119.9 pounds)
Reactions: Weight Increased, Breast Pain, Fatigue, Fungal Infection, Seborrhoea, General Symptom
Drug(s) suspected as cause:
Prometrium
Other drugs received by patient: Plaquenil; Levothyroxine Sodium
Possible Prometrium side effects in female
Reported by a pharmacist from United States on 2012-05-15
Patient: female
Reactions: Vaginal Discharge
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: Fatigue, Frequent Bowel Movements, Ill-Defined Disorder, Somnolence
Drug(s) suspected as cause:
Prometrium
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