Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Clinical Trial Adverse Events.
Clomiphene citrate, at recommended dosages, is generally well tolerated.
Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.
Adverse experiences reported in patients treated with clomiphene citrate during clinical studies are shown in Table
Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*) Adverse Event % Ovarian Enlargement 13.6 Vasomotor Flushes 10.4 Abdominal-Pelvic Discomfort/Distention/Bloating 5.5 Nausea and Vomiting 2.2 Breast Discomfort 2.1 Visual Symptoms Blurred vision, lights, floaters, waves, unspecified visualcomplaints, photophobia, diplopia, scotomata, phosphenes 1.5 Headache 1.3 Abnormal Uterine Bleeding Intermenstrual spotting, menorrhagia 1.3 *Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such.
Also, excludes 47 patients who did not report symptom data.
The following adverse events have been reported in fewer than 1% of patients in clinical trials: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.
Patients on prolonged clomiphene citrate therapy may show elevated serum levels of desmosterol.
This is most likely due to a direct interference with cholesterol synthesis.
However, the serum sterols in patients receiving the recommended dose of clomiphene citrate are not significantly altered.
WARNINGS Visual Symptoms Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during therapy with clomiphene citrate.
These visual symptoms increase in incidence with increasing total dose or therapy duration.
These visual disturbances are usually reversible;
however, cases of prolonged visual disturbance have been reported with some occurring after clomiphene citrate discontinuation.
The visual disturbances may be irreversible, especially with increased dosage or duration of therapy.
Like all medications, Clomiphene Citrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: