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The following safety information highlights critical warnings associated with the use of baclofen. It is essential to understand these risks and discuss any concerns with your healthcare provider.

• Withdrawal Symptoms: Abruptly discontinuing baclofen after prolonged use can lead to severe withdrawal symptoms such as tremors, muscle rigidity, and seizures. It is crucial to consult your healthcare provider to safely reduce the dosage if you intend to stop the medication. This is particularly important for individuals who have been on baclofen long-term and newborns whose mothers used the drug during pregnancy.

• Drowsiness and Dizziness: Baclofen may cause significant drowsiness and dizziness, which can impair cognitive functions like concentration and alertness. To avoid exacerbating these effects, refrain from consuming alcohol or using other substances that induce sleepiness. Until you understand how baclofen affects you, avoid tasks that require full attention, such as driving or operating heavy machinery. This caution is especially relevant for those combining baclofen with alcohol, other sedatives, or for individuals over 65 years of age.

• Exacerbation of Other Conditions: Before commencing baclofen, disclose all pre-existing medical conditions to your healthcare provider, as the medication can aggravate certain health issues. This includes mental health disorders like schizophrenia, high blood pressure due to spinal cord injury, seizure disorders, and conditions where muscle tone is crucial for maintaining balance or posture.

• Pregnancy Considerations: Baclofen usage is not recommended during pregnancy unless the potential benefits significantly outweigh the risks. Limited studies in humans and animal research suggest potential birth defects and withdrawal symptoms in newborns. Pregnant individuals should thoroughly discuss the risks and benefits with their healthcare team before using baclofen.

No specific contraindications are provided for this medication; however, always consult with a healthcare professional before starting any new treatment.

When using this medication, some individuals may experience common side effects, which are generally mild and manageable. These can include drowsiness, dizziness, weakness, tiredness, and nausea. It is also possible to encounter headache, trouble sleeping, increased urination, or constipation. If these effects persist or worsen, consulting a healthcare provider is advisable to ensure your comfort and safety.

In some cases, individuals may notice a metallic taste in their mouth or a general feeling of low energy. While these side effects are typically not serious, it is still important to monitor them closely. On the other hand, more serious side effects, although rare, require immediate attention. These include mental or mood changes such as confusion, depression, or hallucinations, and extreme sleepiness. Severe allergic reactions, though uncommon, can manifest as rash, itching or swelling, particularly of the face, tongue, or throat, alongside severe dizziness or trouble breathing. Immediate medical care is essential if these symptoms appear.

While the majority of people do not experience serious side effects, being informed about potential reactions can help in quickly addressing any concerns. Always reach out to a healthcare provider if you notice any unusual symptoms or side effects not mentioned here.

When taking Baclofen, it is important to inform your doctor or pharmacist if you are using other substances that can cause drowsiness. These include opioid pain or cough medications like codeine and hydrocodone, alcohol, marijuana (cannabis), sleep or anxiety drugs such as alprazolam, lorazepam, or zolpidem, other muscle relaxants like carisoprodol or cyclobenzaprine, and antihistamines such as cetirizine and diphenhydramine. Many allergy or cold medications might also have ingredients that lead to drowsiness, so check their labels and consult your pharmacist for safe usage.

Additionally, Baclofen can interact with a variety of other medications. Some interactions may require your doctor to adjust dosages or how you take the medications. These include, but are not limited to, medicines like alprazolam, buprenorphine, cetirizine, codeine, fentanyl, gabapentin, hydrocodone, ketamine, methadone, morphine, oxycodone, tramadol, and zolpidem. Always keep your healthcare providers informed about all the medications and supplements you are taking, whether they are prescription, over-the-counter, vitamins, or herbal products.