Prometrium Side Effects

Generic Name: progesterone

Note: This page contains side effects data for the generic drug progesterone. It is possible that some of the dosage forms included below may not apply to the brand name Prometrium.

It is possible that some side effects of Prometrium may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to progesterone: oral capsule, oral capsule liquid filled

As well as its needed effects, progesterone (the active ingredient contained in Prometrium) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking progesterone, check with your doctor immediately:

More common
  • Chest pain
  • chills
  • cold or flu-like symptoms
  • cough or hoarseness
  • fever
  • problems with urination
Less common
  • Clear or bloody discharge from the nipple
  • dimpling of the breast skin
  • inverted nipple
  • lump in the breast or under the arm
  • persistent crusting or scaling of the nipple
  • redness or swelling of the breast
  • sore on the skin of the breast that does not heal
Incidence not known
  • Abdominal or stomach pain
  • bloating
  • blurred vision
  • change in vaginal discharge
  • clay-colored stools
  • cleft lip or palate
  • confusion
  • constipation
  • darkened urine
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • difficulty with walking
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • hives
  • indigestion
  • irregular heartbeat
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • lightheadedness
  • loss of appetite
  • nausea
  • nervousness
  • noisy breathing
  • numbness or tingling in the face, arms, or legs
  • pain or feeling of pressure in the pelvis
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of the skin
  • shortness of breath
  • slow heartbeat
  • spontaneous abortion
  • stomach or pelvic discomfort, aching, or heaviness
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble speaking, thinking, or walking
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting
  • vomiting of blood
  • wheezing
  • yellow eyes or skin

Some progesterone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Breast pain or tenderness
  • depression
  • muscle or joint pain
  • white or brownish vaginal discharge
  • worry
Incidence not known
  • Attack, assault, or force
  • blurred or loss of vision
  • change in walking and balance
  • changes in behavior
  • changes in patterns and rhythms of speech
  • choking
  • clumsiness or unsteadiness
  • confusion about identity, place, and time
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased awareness or responsiveness
  • difficulty with moving
  • disturbed color perception
  • double vision
  • drowsiness
  • extreme dizziness or drowsiness
  • feeling drunk
  • feeling of constant movement of self or surroundings
  • feeling of unreality
  • hair loss or thinning of the hair
  • halos around lights
  • hearing loss
  • hives or welts
  • longer or heavier menstrual periods
  • loss of consciousness
  • muscle cramps
  • muscle stiffness
  • night blindness
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  • overbright appearance of lights
  • redness of the skin
  • relaxed and calm
  • sensation of spinning
  • sense of detachment from self or body
  • severe sleepiness
  • sleepiness
  • slurred speech
  • swollen tongue
  • thoughts of killing oneself
  • tunnel vision
  • weight changes

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[Ref]

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.[Ref]

Cardiovascular

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

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 Prometrium) gel 8% have included constipation (27%), nausea (22%), and diarrhea (8%).[Ref]

Musculoskeletal

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

Psychiatric

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

Respiratory

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

Dermatologic

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

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

Ocular

Ocular side effects have included abnormal vision.[Ref]

Hepatic

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

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.[Ref]

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.[Ref]

Local

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

References

1. "Product Information. Prometrium (progesterone)." Solvay Pharmaceuticals, Marietta, GA.

2. Wilkinson SM, Beck MH, Kingston TP "Progesterone-induced urticaria - need it be autoimmune?" Br J Dermatol 133 (1995): 792-4

3. Chawla SV, Quirk C, Sondheimer SJ, James WD "Autoimmune progesterone dermatitis." Arch Dermatol 145 (2009): 341-2

4. Halevy S, Cohen AD, Lunenfeld E, Grossman N "Autoimmune progesterone dermatitis manifested as erythema annulare centrifugum: Confirmation of progesterone sensitivity by in vitro interferon-gamma release." J Am Acad Dermatol 47 (2002): 311-3

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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