Short answer: In clinical studies of 8029 women, the most common Clomid side effects were ovarian enlargement (13.6%), hot flashes (10.4%), stomach and pelvic discomfort or bloating (5.5%), nausea and vomiting (2.2%), breast discomfort (2.1%) and visual symptoms (1.5%). The label gives no placebo comparison. It says reactions are usually mild and short-lived, and it has no boxed warning.
What Clomid is approved for: Clomid is approved to treat ovulatory dysfunction (not ovulating normally) in women who want to become pregnant, after other causes of infertility are ruled out or treated. The label says there are no adequate studies showing it works for male infertility, and it is not recommended for IVF or combined ovulation-induction regimens (Indications and Usage).
Source
Clomid (clomiPHENE citrate) Tablets, USP, prescribing information. Cosette Pharmaceuticals. DailyMed, version published February 3, 2025. DailyMed setid 2ca373c1-4dba-4126-8616-5c533d606fe5
No. The current Clomid label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Clomid.
| 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 visual complaints, photophobia, diplopia, scotomata, phosphenes) | 1.5 |
| Headache | 1.3 |
| Abnormal Uterine Bleeding (Intermenstrual spotting, menorrhagia) | 1.3 |
Women treated with clomiphene citrate in clinical studies; there was no placebo column. The label notes the total includes 498 patients whose reports may have been counted twice and excludes 47 who reported no symptom data.
Reported in fewer than 1% of patients: acute abdomen, increased appetite, constipation, rash, depression, diarrhea, dizziness, fatigue, hair loss or dry hair, more frequent urination, trouble sleeping, light-headedness, nervous tension, vaginal dryness, vertigo, and weight gain or loss.
In clinical studies, among patients with a known pregnancy outcome, the miscarriage rate was 20.4% and the stillbirth rate was 1.0%. The label says available data suggest no increase in miscarriage or birth defects compared with the general population.
One study patient taking 200 mg daily developed blurred vision on day 7 that became a severe loss of sharpness by day 10; vision returned to normal on the 3rd day after stopping. Another patient's spots and flashes disappeared by the 32nd day after stopping.
After approval, reports have included vision problems (including temporary or prolonged, possibly irreversible, loss of vision), high triglycerides sometimes with pancreatitis, ovarian cysts and bleeding, tubal pregnancy, raised liver enzymes and hepatitis, and mood changes; frequencies are not known.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Visual symptoms. Blurring, spots or flashes can occur and become more likely with higher total dose or longer use. They are usually reversible but can last a long time or be permanent. Anyone with visual symptoms stops treatment and has a full eye exam, and the label warns driving may be riskier, especially in changing light.
Ovarian hyperstimulation syndrome (OHSS). OHSS has been reported and can become serious within 24 hours to several days. Early signs are stomach pain and swelling, nausea, vomiting, diarrhea and weight gain. Deaths from shock or blood clots have occurred, and it can get worse quickly if pregnancy occurs.
Ovarian enlargement and cysts. The lowest effective dose is used. Maximum enlargement may come several days after a course ends. If the ovaries enlarge, no more Clomid is given until they return to normal size, and the next course is shortened or lowered. Cysts that do not go away on their own are checked for tumors.
Polycystic ovary syndrome. Some women with PCOS respond strongly to usual doses, so they start on the lowest dose and shortest course for the first cycle.
Pelvic exams between courses. A pelvic exam is needed before the first course and before each later one, and pregnancy, ovarian enlargement and cysts are ruled out between cycles.
High triglycerides and pancreatitis. High triglycerides have been reported, more likely with a personal or family history of high blood fats or higher-than-recommended doses or longer use. Triglycerides are screened before starting. Pancreatitis has been reported.
Multiple pregnancy. There is a higher chance of multiple pregnancy, including tubal pregnancy in both tubes and a tubal pregnancy alongside one in the uterus.
Ovarian cancer. Prolonged use may increase the risk of a borderline or invasive ovarian tumor.
Breastfeeding. It is not known whether clomiphene passes into breast milk, and it may reduce milk supply in some women.
Who should not take it. Pregnancy, liver disease or a history of liver problems, abnormal uterine bleeding of unknown cause, ovarian cysts or enlargement not due to PCOS, uncontrolled thyroid or adrenal disease, a brain lesion such as a pituitary tumor, or allergy to clomiphene.
From the Information for Patients (Precautions) that comes with Clomid:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.