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):

6.1 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 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 System represented from COSTART medical dictionary.
Body as a WholeHeadache (16.5%)
Abdominal pain/discomfort (11.2%)
Metabolic/NutritionalIncreased weight> 10lbs at 24 months (37.7%)
NervousNervousness (10.8%)
Dizziness (5.6%)
Libido decreased (5.5%)
UrogenitalMenstrual irregularities:
(bleeding (57.3% at 12 months, 32.1% at 24 months)
amenorrhea (55% at 12 months, 68% at 24 months)
Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects
Body System*Adverse Reactions [Incidence (%)]
*
Body System represented from COSTART medical dictionary.
Body as a WholeAsthenia/fatigue (4.2%)
Backache (2.2%)
Dysmenorrhea (1.7%)
Hot flashes (1.0%)
DigestiveNausea (3.3%)
Bloating (2.3%)
Metabolic/NutritionalEdema (2.2%)
MusculoskeletalLeg cramps (3.7%)
Arthralgia (1.0%)
NervousDepression (1.5%)
Insomnia (1.0%)
Skin and AppendagesAcne (1.2%)
No hair growth/alopecia (1.1%)
Rash (1.1%)
UrogenitalLeukorrhea (2.9%)
Breast pain (2.8%)
Vaginitis (1.2%)

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

6.2 Post-Marketing 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 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 and Administration (2.1)].
Body as a WholeChest 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
DigestiveChanges in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding
Hematologic and LymphaticAnemia, Blood dyscrasia
MusculoskeletalOsteoporosis
NeoplasmsCervical cancer, Breast cancer
NervousParalysis, Facial palsy, Paresthesia, Drowsiness
RespiratoryDyspnea and asthma, Hoarseness
Skin and AppendagesHirsutism, Excessive sweating and body odor, Dry skin, Scleroderma
UrogenitalLack 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

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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):

6.1 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 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 System represented from COSTART medical dictionary.
Body as a WholeHeadache (16.5%)
Abdominal pain/discomfort (11.2%)
Metabolic/NutritionalIncreased weight> 10lbs at 24 months (37.7%)
NervousNervousness (10.8%)
Dizziness (5.6%)
Libido decreased (5.5%)
UrogenitalMenstrual irregularities:
(bleeding (57.3% at 12 months, 32.1% at 24 months)
amenorrhea (55% at 12 months, 68% at 24 months)
Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects
Body System*Adverse Reactions [Incidence (%)]
*
Body System represented from COSTART medical dictionary.
Body as a WholeAsthenia/fatigue (4.2%)
Backache (2.2%)
Dysmenorrhea (1.7%)
Hot flashes (1.0%)
DigestiveNausea (3.3%)
Bloating (2.3%)
Metabolic/NutritionalEdema (2.2%)
MusculoskeletalLeg cramps (3.7%)
Arthralgia (1.0%)
NervousDepression (1.5%)
Insomnia (1.0%)
Skin and AppendagesAcne (1.2%)
No hair growth/alopecia (1.1%)
Rash (1.1%)
UrogenitalLeukorrhea (2.9%)
Breast pain (2.8%)
Vaginitis (1.2%)

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

6.2 Post-Marketing 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 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 and Administration (2.1)].
Body as a WholeChest 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
DigestiveChanges in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding
Hematologic and LymphaticAnemia, Blood dyscrasia
MusculoskeletalOsteoporosis
NeoplasmsCervical cancer, Breast cancer
NervousParalysis, Facial palsy, Paresthesia, Drowsiness
RespiratoryDyspnea and asthma, Hoarseness
Skin and AppendagesHirsutism, Excessive sweating and body odor, Dry skin, Scleroderma
UrogenitalLack 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
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