First Progesterone MC5 Side Effects

Generic name: progesterone

Note: This document contains side effect information about progesterone. Some of the dosage forms listed on this page may not apply to the brand name First Progesterone MC5.

Some side effects of First Progesterone MC5 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to progesterone: intramuscular solution, oral capsule, topical cream

Get emergency medical help if you have any of these signs of an allergic reaction while taking progesterone (the active ingredient contained in First Progesterone MC5) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

• fast or pounding heartbeats;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• unusual or unexpected vaginal bleeding;

• migraine headache;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• fever, chills, body aches, flu symptoms;

• a breast lump; or

• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects of progesterone may include:

• mild nausea, diarrhea, bloating, stomach cramps;

• dizziness, spinning sensation;

• hot flashes;

• mild headache;

• joint pain;

• breast pain or tenderness;

• cough;

• acne or increased hair growth;

• changes in weight; or

• vaginal itching, dryness, or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to progesterone: compounding powder, intramuscular solution, oral capsule, topical cream, vaginal gel, vaginal insert, vaginal suppository

Genitourinary

Genitourinary side effects have included breast tenderness (27%), urinary problems (11%), vaginal discharge (10%), vaginal dryness (6%), breast pain (6%), breast carcinoma (2%), breast excisional biopsy (2%), breast enlargement, leukorrhea, uterine fibroid, vaginal dryness, fungal vaginitis, vaginitis, dysuria, cystitis, and urinary tract infection

Nervous system

Nervous system side effects have included headache (31%), dizziness (15%), confusion, somnolence, asthenia, increased sweating, nervousness, migraine, tremor, and speech disorder. Syncope (with and without hypotension) have been reported.

Cardiovascular

Cardiovascular side effects have included chest pain (7%), hypertension, angina pectoris, syncope, and palpitations.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (20%), bloating (8%), diarrhea (8%), nausea (8%), constipation (3%), dyspepsia, dry mouth, gastroenteritis, hemorrhagic rectum, hiatus hernia, and vomiting. The side effects reported during clinical studies evaluating the use of progesterone (the active ingredient contained in First Progesterone MC5) gel 8% have included constipation (27%), nausea (22%), and diarrhea (8%).

Musculoskeletal

Musculoskeletal side effects have included joint pain (20%), musculoskeletal pain (12%), back pain (8%), arthritis, leg cramps, hypertonia, muscle disorder, and myalgia.

Psychiatric

Psychiatric side effects have included depression (19%), anxiety, impaired concentration, insomnia, forgetfulness, and personality disorder.

Respiratory

Respiratory side effects have included cough (8%), bronchitis, nasal congestion, pharyngitis, pneumonitis, and sinusitis.

Dermatologic

Dermatologic side effects have included acne, pruritus, rash, skin discoloration, seborrhea, verruca, and wound debridement during therapy.

Additional dermatologic side effects have included case reports of familial autoimmune dermatitis.

Ocular

Ocular side effects have included abnormal vision.

Hepatic

Hepatic side effects including reversible cases of hepatitis, elevated transaminases, and cholecystectomy have been reported.

Other

Other side effects have included viral infection (12%), hot flashes (11%), fatigue (8%), irritability (8%), worry (8%), night sweats (7%), earache, tooth disorder, anorexia, increased appetite, peripheral edema, edema, accidental injury, fever, abscess, lymphadenopathy, and herpes simplex.

Immunologic

Immunologic side effects have included autoimmune dermatitis during the luteal phase of the menstrual cycle. Test results using interferon gamma release in vivo and vitro tests confirmed the diagnosis.

Local

Local side effects have included pain, irritation, and redness at the injection site.

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