Skip to main content
PlainMeds

What the label lists and what reports show

Clomiphene side effects

Clomiphene's FDA label lists its adverse reactions in its own words. FAERS holds 1,483 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is abortion spontaneous (110 reports).

  • Generic listed

Check it at the source: the clomiphene FDA label on DailyMed (effective December 1, 2025, Accord Healthcare Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: 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 2 . Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*) *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. …

Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*)

Adverse Event*Includes 498 patients whose reports may have been duplicated in the event totals and… %
Ovarian Enlargement13.6
Vasomotor Flushes10.4
Abdominal-Pelvic Discomfort/Distention/Bloating5.5
Nausea and Vomiting2.2
Breast Discomfort2.1
Visual Symptoms1.5
Headache1.3
Abnormal Uterine Bleeding1.3

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Accord Healthcare Inc., effective December 1, 2025 (SPL set 79f64995-7425-44c6-9f44-f7d20daeff65), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,483 reports list clomiphene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 52 are coded as a death and 334 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Abortion Spontaneous110
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)107
  • Nausea (named in the label)87
  • Off Label Use (a use or a product term, not a reaction)83
  • Headache (named in the label)81
  • Drug Ineffective (a use or a product term, not a reaction)74
  • Exposure During Pregnancy (a use or a product term, not a reaction)74
  • Vomiting (named in the label)65
  • Fatigue (named in the label)60
  • Diarrhoea (named in the label)54
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)54
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)49
  • Insomnia (named in the label)47
  • Pregnancy (a use or a product term, not a reaction)47
  • Dizziness (named in the label)45
  • Ovarian Hyperstimulation Syndrome (a use or a product term, not a reaction)43
  • Premature Baby42
  • Anxiety (named in the label)38
  • Pain37
  • Weight Increased35
  • Arthralgia (named in the label)31
  • Depression29
  • Ovarian Cyst (a use or a product term, not a reaction)29
  • Pyrexia29
  • Feeling Abnormal28

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Clomiphene: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions