DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Medroxyprogesterone (Medroxyprogesterone Acetate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section (5):

  • Loss of Bone Mineral Density [see Warnings and Precautions (5.1)
  • Thromboembolic disease [see Warnings and Precautions (5.2)
  • Breast Cancer [see Warnings and Precautions (5.3)
  • Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.5)
  • Bleeding Irregularities[see Warnings and Precautions (5.9)
  • Weight Gain [see Warnings and Precautions (5.10)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two clinical trials with medroxyprogesterone acetate injectable suspension, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of medroxyprogesterone acetate injectable suspension. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg medroxyprogesterone acetate injectable suspension every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months.

Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects

Body System* Adverse Reactions (Incidence (%))
Body as a Whole

Headache (16.5%)

Abdominal pain/discomfort (11.2%)

Metabolic/Nutritional Increased weight > 10 lbs at 24 months (37.7%)
Nervous

Nervousness (10.8%)

Dizziness (5.6%)

Libido decreased (5.5%)

Urogenital

Menstrual irregularities:

(bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months)

 * Body System represented from COSTART medical dictionary.

 

Table 2. Adverse Reactions that Were Reported by between 1 and 5% of Subjects

Body System* Adverse Reactions (Incidence (%))
Body as a Whole

Asthenia/fatigue (4.2%)

Backache (2.2%)

Dysmenorrhea (1.7%)

Hot flashes (1%)

Digestive

Nausea (3.3%)

Bloating (2.3%)

Metabolic/Nutritional Edema (2.2%)
Musculoskeletal

Leg cramps (3.7%)

Arthralgia (1%)

Nervous

Depression (1.5%)

Insomnia (1%)

Skin and Appendages

Acne (1.2%)

No hair growth/alopecia (1.1%)

Rash (1.1%)

Urogenital

Leukorrhea (2.9%)

Breast pain (2.8%)

Vaginitis (1.2%)

 * Body System represented from COSTART medical dictionary.

Adverse reactions leading to study discontinuation in ≥ 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)

Post-marketing Experience

The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate injectable suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate injectable suspension.

Table 3. Adverse Reactions Reported during Post-Marketing Experience

Body System Adverse Reactions
Body as a Whole Chest pain, Allergic reactions, Fever, Pain at injection site, Chills, Axillary swelling
Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins
Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding
Hematologic and Lymphatic Anemia, Blood dyscrasia
Musculoskeletal Osteoporosis
Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness
Respiratory Dyspnea and asthma, Hoarseness
Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma
Urogenital Cervical cancer, Breast cancer, Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia

 * Body System represented from COSTART medical dictionary.



REPORTS OF SUSPECTED MEDROXYPROGESTERONE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Medroxyprogesterone. The information is not vetted and should not be considered as verified clinical evidence.

Possible Medroxyprogesterone side effects / adverse reactions in 57 year old female

Reported by a lawyer from United States on 2011-10-03

Patient: 57 year old female

Reactions: Breast Cancer

Suspect drug(s):
Medroxyprogesterone

Estradiol and Norethindrone Acetate

Provella-14



Possible Medroxyprogesterone side effects / adverse reactions in 30 year old female

Reported by a lawyer from United States on 2011-11-01

Patient: 30 year old female weighing 70.8 kg (155.7 pounds)

Reactions: Goitre, Pulmonary Embolism, Headache, Autoimmune Thyroiditis, Accident AT Work, Multiple Injuries, Emotional Disorder, Menorrhagia, Back Pain, Phlebitis, Ovarian Cyst, Breast Mass, Blood Thyroid Stimulating Hormone Decreased, Operative Haemorrhage, Mental Disorder, Pelvic Fluid Collection, Fractured Coccyx, Breast Inflammation, Head Injury, Pain, Dysfunctional Uterine Bleeding, Pelvic Pain, Fall, Disease Progression, Breast Infection, Chest Pain, Intervertebral Disc Degeneration, Depression, Latex Allergy, Pharyngitis, Nausea, Cognitive Disorder, Anxiety, Breast Swelling, Flank Pain, Coccydynia, Breast Fibrosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Medroxyprogesterone
    Indication: Contraception
    Start date: 2008-02-08

Nuvaring
    Dosage: vag
    Indication: Contraception
    Start date: 2007-12-03
    End date: 2008-02-08

Nuvaring
    Dosage: vag
    Indication: Vaginal Haemorrhage
    Start date: 2007-12-03
    End date: 2008-02-08

Other drugs received by patient: Hydrocodone Bitartrate and Acetaminophen; Cephalexin; Tobradex; Syntroid



Possible Medroxyprogesterone side effects / adverse reactions in 24 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-17

Patient: 24 year old female

Reactions: Dysarthria, Dystonia, Grimacing, Skin Discolouration, Dyskinesia, Laceration, Gait Disturbance, Alcohol Poisoning

Adverse event resulted in: hospitalization

Suspect drug(s):
Cetirizine
    Dosage: 10 mg/day

Medroxyprogesterone
    Dosage: depot

Valacyclovir
    Dosage: daily
    Indication: Herpes Simplex



See index of all Medroxyprogesterone side effect reports >>

Drug label data at the top of this Page last updated: 2012-08-13

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017