Common Side Effects of Veozah 45 mg
Clinical trials of Veozah have identified several common side effects, which typically affect a small percentage of patients and are generally mild. The most frequently reported issues include stomach or abdominal pain, diarrhea, and insomnia.
- Stomach (Abdominal) Pain: Affecting approximately 4% of users in clinical trials, this side effect can range from mild discomfort to more noticeable pain.
- Diarrhea: Experienced by a similar number of patients, diarrhea is a common gastrointestinal side effect. Staying well-hydrated is important for managing this symptom.
- Insomnia: Sleep disturbances were reported in clinical studies, although some patients may find their sleep improves due to the medication’s effect on managing night sweats. Taking the medication earlier in the day may help mitigate this side effect.
- Back Pain: Back pain has also been identified as a common side effect for some individuals taking Veozah. Gentle stretching or applying a heat pack can offer relief.
- Hot Flushes: While the purpose of Veozah is to treat hot flashes, some patients reported hot flushes as a side effect. This may also be a reflection of the underlying menopause symptoms.
The Serious Risk of Liver Injury: An FDA Boxed Warning
A rare but serious risk associated with Veozah is hepatotoxicity, or liver damage, which is significant enough for the FDA to issue a boxed warning. In postmarketing experience, rare cases of serious drug-induced liver injury have occurred, sometimes within 40 days of starting treatment.
Key symptoms of serious liver problems include:
- Unusual fatigue or weakness
- Nausea and vomiting
- Abdominal pain, particularly in the right upper side
- Unexplained itching
- Dark urine
- Yellowing of the skin or eyes (jaundice)
- Light-colored or pale feces
Patients experiencing any of these symptoms should contact their healthcare provider immediately and stop taking Veozah. To mitigate this risk, patients undergo routine blood tests to check liver function before and during treatment.
Drug Interactions and Contraindications
Veozah is not suitable for everyone and has important drug interactions and contraindications that patients and providers must consider.
Contraindicated Conditions
Patients with certain pre-existing conditions should not take Veozah:
- Cirrhosis: Due to the risk of liver damage, Veozah is contraindicated in women with known cirrhosis.
- Severe Renal Impairment or End-Stage Renal Disease: These conditions can affect how the body clears the medication, potentially leading to increased drug levels and a higher risk of side effects.
Significant Drug Interactions
Veozah is metabolized by the enzyme CYP1A2. Concomitant use with drugs that inhibit this enzyme can increase the concentration of Veozah in the body, raising the risk of side effects.
Drugs and substances known to be CYP1A2 inhibitors include:
- Cimetidine: An ulcer medication
- Fluvoxamine: An antidepressant used for obsessive-compulsive disorder (OCD)
- Certain Combined Hormonal Birth Control Pills: Containing ethinyl estradiol
- Mexiletine: A medication for irregular heartbeats
- Ciprofloxacin: An antibiotic
Before starting Veozah, patients must provide their healthcare provider with a complete list of all medications, supplements, and herbal products they are taking.
Comparison of Veozah and Hormone Replacement Therapy (HRT) Side Effects
For some women, Veozah presents a non-hormonal alternative to traditional HRT for managing menopausal hot flashes. The side effect profiles of these treatments differ significantly. The following table provides a general comparison, but individual risk profiles vary.
| Feature | Veozah (Fezolinetant) | Hormone Replacement Therapy (HRT) |
|---|---|---|
| Mechanism of Action | Blocks the neurokinin 3 (NK3) receptor in the brain's thermoregulatory center. | Replenishes declining estrogen levels, either alone or with progestin. |
| Hormonal vs. Non-Hormonal | Non-hormonal. | Hormonal. |
| Most Common Side Effects | Abdominal pain, diarrhea, insomnia, back pain, hepatic transaminase elevation. | Nausea, bloating, headaches, breast tenderness, vaginal bleeding. |
| Serious Side Effect Risks | Rare but serious liver damage (hepatotoxicity), leading to an FDA boxed warning. Endometrial hyperplasia/malignancy (rare). | Increased risk of blood clots, stroke, heart disease, breast cancer, gallbladder disease. |
| Monitoring Required | Liver function tests (LFTs) required before starting and regularly (monthly for 3 months, then at 6 and 9 months). | Often includes periodic check-ups and mammograms; endometrial assessment may be needed depending on HRT type. |
| Targeted Symptoms | Focuses specifically on hot flashes and night sweats (vasomotor symptoms). | Addresses a broader range of menopausal symptoms, including hot flashes, vaginal dryness, and mood changes. |
Navigating Treatment: What to Do If You Experience Side Effects
Managing side effects is a crucial part of any medication regimen. For those taking Veozah, proactive communication with a healthcare provider is essential.
- For common side effects: Mild abdominal pain, diarrhea, or back pain can often be managed with simple home remedies or lifestyle adjustments. For instance, staying hydrated can help with diarrhea, while a cool room or timing your dose can alleviate insomnia. If these issues persist or worsen, contact your doctor for personalized advice.
- For serious side effects (liver damage): The FDA’s boxed warning on Veozah underscores the need to be vigilant for signs of liver problems, especially within the first few months of treatment. If you notice new onset fatigue, nausea, vomiting, unusual itching, dark urine, or yellowing of the skin/eyes, stop the medication immediately and seek medical attention. Timely discontinuation can prevent further injury.
- Adherence to monitoring: Regular liver function testing is a mandatory part of Veozah treatment. Missing these appointments could put you at risk of undetected liver problems. These tests establish a baseline before you start and provide ongoing monitoring throughout the initial treatment phase.
Conclusion
Veozah 45 mg is an effective non-hormonal treatment for moderate to severe menopausal hot flashes, but it comes with a known set of potential side effects that must be carefully managed. The most serious concern is the risk of liver damage, highlighted by an FDA boxed warning, which requires regular monitoring through blood tests. Common side effects, such as abdominal pain, diarrhea, and insomnia, are typically mild and can often be managed. It is also crucial to avoid Veozah if you have cirrhosis, severe kidney problems, or are taking certain CYP1A2 inhibitor medications. Before starting treatment, a thorough discussion with your healthcare provider about your medical history and all current medications is essential to ensure the safe use of Veozah. [https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due].
