This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (85)
Death (17)
Life Threatening Events (7)
Disability (1)
Reports by Reaction Type
Foetal Exposure During Pregnancy (14),
Premature Baby (10),
Maternal Exposure During Pregnancy (9),
Death Neonatal (8),
Drug Ineffective (7),
Jaundice (6),
LOW Birth Weight Baby (6),
Nausea (6),
Headache (5),
Abdominal Pain Upper (5),
Pain (4),
Hyperhidrosis (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Progesterone. For a complete list or a specific selection of reports, please use the links above.
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Hot Flush, Incontinence, Drug Intolerance, Headache, Feeling Abnormal, Ill-Defined Disorder, Nervousness
Drug(s) suspected as cause:
Prempro
Dosage: unk
Premarin
Dosage: unk
Progesterone
Dosage: unk
Possible Progesterone side effects in 38 year old female
Reported by a physician from Philippines on 2012-08-17
Patient: 38 year old female
Reactions: Caesarean Section, Procedural Haemorrhage, Maternal Exposure During Pregnancy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Progesterone
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Progesterone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Possible Progesterone side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-09
Patient: female
Reactions: Digeorge's Syndrome, Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Dexamethasone
Indication: Infertility
Humira
Indication: Infertility
Kiovig
Indication: Off Label Use
Enoxaparin Sodium
Indication: Antiinflammatory Therapy
Progesterone
Indication: Infertility
Kiovig
Indication: Infertility
Aspirin
Indication: Infertility
Possible Progesterone side effects in 59 year old female
Reported by a physician from France on 2012-06-21
Patient: 59 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Haemangioma
Drug(s) suspected as cause:
Actemra
Indication: Product Used FOR Unknown Indication
Start date: 2009-02-01
Progesterone
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2003-01-01
Estradiol
Indication: Hormone Replacement Therapy
Start date: 2003-01-01
Other drugs received by patient: Indapamide
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Drug Ineffective FOR Unapproved Indication, Skin Induration, Bone Disorder
Drug(s) suspected as cause:
Progesterone
Dosage: unk
Indication: Off Label Use
Start date: 1968-01-01
End date: 2012-03-01
Premarin
Dosage: two tablets of 1.25mg, daily
Administration route: Oral
Indication: Hormone Therapy
Progesterone
Indication: Hormone Therapy
Depo-Estradiol
Dosage: 10mg/ml, once every two week
Indication: Hormone Therapy
End date: 2012-03-01
Depo-Estradiol
Dosage: 10mg/ml, once every week
Indication: Off Label Use
Start date: 1968-01-01
Depo-Estradiol
Dosage: unk
End date: 2012-03-01
Premarin
Dosage: 2.5 mg, daily
Administration route: Oral
Indication: Off Label Use
Start date: 1968-01-01
Other drugs received by patient: Vitamin B-12
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from Germany on 2012-05-18
Patient: female, weighing 3.0 kg (6.5 pounds)
Reactions: LOW Birth Weight Baby, Hypoplastic Left Heart Syndrome, Necrotising Colitis, Turner's Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cetirizine Hydrochloride
Indication: Foetal Exposure During Pregnancy
Start date: 2010-10-01
End date: 2011-06-01
Metformin HCL
Indication: Foetal Exposure During Pregnancy
Start date: 2010-09-01
End date: 2010-11-01
Levothyroxine Sodium
Indication: Foetal Exposure During Pregnancy
Start date: 2010-09-13
End date: 2011-06-26
Clotrimazole
Indication: Foetal Exposure During Pregnancy
Cetirizine Hydrochloride
Ebenol
Indication: Foetal Exposure During Pregnancy
Start date: 2010-11-14
End date: 2010-11-17
Albuterol
Indication: Foetal Exposure During Pregnancy
Start date: 2010-12-20
End date: 2010-12-25
Iodine
Indication: Foetal Exposure During Pregnancy
Start date: 2010-09-19
End date: 2011-04-04
Progesterone
Indication: Foetal Exposure During Pregnancy
Start date: 2010-09-12
End date: 2010-11-14
Folic Acid
Indication: Foetal Exposure During Pregnancy
Start date: 2010-09-19
End date: 2011-04-04
Emser Salt
Indication: Foetal Exposure During Pregnancy
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female
Reactions: Dizziness, Feeling Abnormal
Drug(s) suspected as cause:
Progesterone
Dosage: daily dose: 200 milligram(s); takes for 10 days monthly
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
End date: 2011-04-01
Progesterone
Dosage: daily dose: 200 milligram(s), bad batch of medication.
Administration route: Oral
Start date: 2011-05-01
Other drugs received by patient: Estrogens Conjugated
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Body Height Decreased, Feeling Abnormal, Ovarian Cancer
Drug(s) suspected as cause:
Premarin
Dosage: 1.25 mg, daily
Administration route: Oral
Indication: Menopausal Symptoms
Progesterone
Dosage: unk
Premarin
Indication: Menopause
Other drugs received by patient: Vitamin C
Possible Progesterone side effects in male
Reported by a physician from Greece on 2012-05-09
Patient: male
Reactions: Caesarean Section, Maternal Drugs Affecting Foetus, Apgar Score LOW, Premature Baby, Foetal Exposure During Pregnancy, Gastroenteritis
Drug(s) suspected as cause:
Progesterone
Indication: Maternal Exposure Timing Unspecified
Paricalcitol
Indication: Maternal Exposure Timing Unspecified
Folic Acid
Indication: Maternal Exposure Timing Unspecified
Vitamin B Complex CAP
Indication: Maternal Exposure Timing Unspecified
Other drugs received by patient: Levocarnitine; Darbepoetin Alfa; Sevelamer Hydrochloride
Possible Progesterone side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-09
Patient: female
Reactions: Jaundice, Asterixis, Hepatic Failure, Encephalopathy, Hepatitis Toxic, Liver Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Progesterone
Administration route: Oral
Indication: Hormone Replacement Therapy
Escitalopram
Indication: Major Depression
Disulfiram
Indication: Alcoholism
Start date: 2011-05-01
End date: 2011-06-01
Other drugs received by patient: Levothyroxine Sodium; Milnacipran; Oxazepam; Estradiol
Possible Progesterone side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-09
Patient: female
Reactions: Jaundice, Asterixis, Encephalopathy, Hepatic Failure, Hepatitis Toxic, Liver Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Progesterone
Administration route: Oral
Indication: Hormone Replacement Therapy
Escitalopram
Indication: Major Depression
Disulfiram
Indication: Alcoholism
Start date: 2011-05-01
End date: 2011-06-01
Other drugs received by patient: Oxazepam; Levothyroxine Sodium; Estradiol; Milnacipran
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Movement Disorder, Arthralgia, Pain, Arthritis
Drug(s) suspected as cause:
Progesterone
Start date: 2012-02-01
End date: 2012-02-01
Estradiol
Dosage: 0.5
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-02-01
End date: 2012-02-01
Medroxyprogesterone
Dosage: 0.45/1.5
Administration route: Oral
Indication: Menopausal Symptoms
End date: 2012-01-01
Estradiol
Indication: Mood Swings
Estradiol
Indication: Anxiety
Medroxyprogesterone
Indication: Mood Swings
Estradiol
Indication: Hot Flush
Medroxyprogesterone
Indication: Anxiety
Medroxyprogesterone
Indication: Hot Flush
Possible Progesterone side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-30
Patient: female
Reactions: Jaundice, Asterixis, Encephalopathy, Hepatic Failure, Hepatitis Toxic, Liver Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Progesterone
Administration route: Oral
Indication: Hormone Replacement Therapy
Esperal
Indication: Alcoholism
Start date: 2011-05-01
End date: 2011-06-01
Escitalopram
Indication: Major Depression
Other drugs received by patient: Oxazepam; Estreva; Ixel; Levothyroxine Sodium
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-20
Patient: female, weighing 68.9 kg (151.6 pounds)
Reactions: Hypokinesia, Arthralgia, Musculoskeletal Pain, Pain, Arthritis
Drug(s) suspected as cause:
Progesterone
Indication: Hot Flush
Progesterone
Indication: Anxiety
Estradiol
Indication: Mood Swings
Progesterone
Dosage: 1.25 mg, 1x/day
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-02-01
End date: 2012-02-01
Progesterone
Indication: Mood Swings
Estradiol
Dosage: 0.5 mg, 1x/day
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-02-01
End date: 2012-02-01
Estradiol
Indication: Anxiety
Estradiol
Indication: Hot Flush
Other drugs received by patient: Prempro; Prempro
Possible Progesterone side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: 57 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Product Substitution Issue, Abdominal Discomfort, Malaise, Nausea, Device Malfunction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Progesterone
Other drugs received by patient: Progesterone
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: female
Reactions: Blood Follicle Stimulating Hormone Decreased
Drug(s) suspected as cause:
Clomid
Indication: in Vitro Fertilisation
Estradiol
Indication: in Vitro Fertilisation
Progesterone
Indication: in Vitro Fertilisation
Possible Progesterone side effects in 38 year old female
Reported by a physician from Ukraine on 2012-04-12
Patient: 38 year old female
Reactions: Systemic Lupus Erythematosus
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Divigel
Start date: 2009-01-01
Progesterone
Start date: 2009-01-01
Lisinopril
Administration route: Oral
Indication: Hypertension
Methyldopa
Indication: Hypertension
Metoprolol Tartrate
Progesterone
Start date: 2009-01-01
Progesterone
Start date: 2009-01-01
Other drugs received by patient: Curantyl; Aspigrel
Possible Progesterone side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-05
Patient:
Reactions: Medication Error
Drug(s) suspected as cause:
Empty Gelatin Capsules
Progesterone
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Body Height Decreased, Feeling Abnormal, Ovarian Cancer
Drug(s) suspected as cause:
Premarin
Administration route: Oral
Progesterone
Dosage: unk
Premarin
Dosage: 1.25 mg, 1x/day
Administration route: Oral
Indication: Menopausal Symptoms
Other drugs received by patient: Ascorbic Acid
Possible Progesterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Movement Disorder, Arthralgia, Pain, Arthritis
Drug(s) suspected as cause:
Estradiol
Dosage: 0.5
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2012-02-01
End date: 2012-02-01
Estradiol
Indication: Mood Swings
Estradiol
Indication: Anxiety
Medroxyprogesterone
Dosage: 0.45/1.5
Administration route: Oral
Indication: Menopausal Symptoms
End date: 2012-01-01
Medroxyprogesterone
Indication: Mood Swings
Medroxyprogesterone
Indication: Anxiety
Estradiol
Indication: Hot Flush
Progesterone
Start date: 2012-02-01
End date: 2012-02-01
Medroxyprogesterone
Indication: Hot Flush
Possible Progesterone side effects in 66 year old female
Reported by a physician from France on 2012-03-27
Patient: 66 year old female, weighing 67.0 kg (147.4 pounds)
Reactions: Transient Ischaemic Attack
Drug(s) suspected as cause:
Progesterone
Dosage: 3 in 1 wk,
Indication: Menopause
Estradiol
Dosage: 1 pump, 1 in 1 d, transdermal
Indication: Menopause
Other drugs received by patient: Crestor; Lexomil (Bromazepam)
Possible Progesterone side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-23
Patient: female, weighing 78.0 kg (171.6 pounds)
Reactions: Mitral Valve Disease, Aortic Valve Disease
Drug(s) suspected as cause:
Mediator
Dosage: daily dose: 3 dosage form
Indication: Weight Decreased
Start date: 2002-07-17
End date: 2003-05-14
Indapamide
Dosage: daily dose: 1.5 milligram(s)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Acetaminophen W / Codeine
Dosage: daily dose: unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Estradiol
Dosage: daily dose: unknown
Indication: Product Used FOR Unknown Indication
Progesterone
Dosage: daily dose: unknown
Indication: Product Used FOR Unknown Indication
Ramipril
Dosage: daily dose: 10 milligram(s)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
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