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Progesterone (Progesterone) - Side Effect Reports to FDA

 
 



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

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 2012-07-23

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 2012-07-13

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

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 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 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 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 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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