DEPO-PROVERA® CI Adverse Reactions

(medroxyprogesterone acetate injectable suspension, for intramuscular use)

6 ADVERSE REACTIONS

The following important adverse reactions observed with the use of Depo-Provera CI 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 (5.10)]
•
Weight Gain [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Clinical trials are conducted under widely varying conditions, therefore, 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 Depo-Provera CI, 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 Depo-Provera CI. 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 Depo-Provera CI 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 lb at 24 months (37.7%)
 
Nervous
 
Nervousness (10.8%)
 
Dizziness (5.6%)
 
Libido decreased (5.5%)
 
Reproductive (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 (1.0%)
 
Digestive
 
Nausea (3.3%)
 
Bloating (2.3%)
 
Metabolic/Nutritional
 
Edema (2.2%)
 
Musculoskeletal
 
Leg cramps (3.7%)
 
Arthralgia (1.0%)
 
Nervous
 
Depression (1.5%)
 
Insomnia (1.0%)
 
Skin and Appendages
 
Acne (1.2%)
 
No hair growth/alopecia (1.1%)
 
Rash (1.1%)
 
Reproductive (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%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Depo-Provera CI. 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 Depo-Provera CI.

 
Table 3. Adverse Reactions Reported during Post-Marketing Experience
 
Body System*
 
Adverse Reactions
 
Body as a Whole
 
Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess†, Injection site infection†, Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, 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
 
Neoplasms
 
Cervical cancer, Breast cancer
 
Nervous
 
Paralysis, Facial palsy, Paresthesia, Drowsiness
 
Respiratory
 
Dyspnea and asthma, Hoarseness
 
Skin and Appendages
 
Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma, Melasma, Chloasma
 
Reproductive (Urogenital*)
 
Lack of return to fertility, Unexpected pregnancy, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Increased libido, Uterine hyperplasia, Vaginal cysts, Genitourinary infections, Dyspareunia
 
* Body System represented from COSTART medical dictionary.
 
† Injection site abscess and injection site infections have been reported; therefore, strict aseptic injection technique should be followed when administering Depo‑Provera CI in order to avoid injection site infections [see Dosage andAdministration (2.1)].

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Adverse Reactions

6 ADVERSE REACTIONS

The following important adverse reactions observed with the use of Depo-Provera CI 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 (5.10)]
•
Weight Gain [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Clinical trials are conducted under widely varying conditions, therefore, 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 Depo-Provera CI, 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 Depo-Provera CI. 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 Depo-Provera CI 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 lb at 24 months (37.7%)
 
Nervous
 
Nervousness (10.8%)
 
Dizziness (5.6%)
 
Libido decreased (5.5%)
 
Reproductive (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 (1.0%)
 
Digestive
 
Nausea (3.3%)
 
Bloating (2.3%)
 
Metabolic/Nutritional
 
Edema (2.2%)
 
Musculoskeletal
 
Leg cramps (3.7%)
 
Arthralgia (1.0%)
 
Nervous
 
Depression (1.5%)
 
Insomnia (1.0%)
 
Skin and Appendages
 
Acne (1.2%)
 
No hair growth/alopecia (1.1%)
 
Rash (1.1%)
 
Reproductive (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%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Depo-Provera CI. 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 Depo-Provera CI.

 
Table 3. Adverse Reactions Reported during Post-Marketing Experience
 
Body System*
 
Adverse Reactions
 
Body as a Whole
 
Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess†, Injection site infection†, Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, 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
 
Neoplasms
 
Cervical cancer, Breast cancer
 
Nervous
 
Paralysis, Facial palsy, Paresthesia, Drowsiness
 
Respiratory
 
Dyspnea and asthma, Hoarseness
 
Skin and Appendages
 
Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma, Melasma, Chloasma
 
Reproductive (Urogenital*)
 
Lack of return to fertility, Unexpected pregnancy, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Increased libido, Uterine hyperplasia, Vaginal cysts, Genitourinary infections, Dyspareunia
 
* Body System represented from COSTART medical dictionary.
 
† Injection site abscess and injection site infections have been reported; therefore, strict aseptic injection technique should be followed when administering Depo‑Provera CI in order to avoid injection site infections [see Dosage andAdministration (2.1)].
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