If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
Laevolac Side Effects Reported to FDA
Laevolac Side Effect Report#9058400 Abdominal Pain, Hyperhidrosis, Paraesthesia, Vomiting, Off Label Use
This is a report of a 73-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Laevolac (dosage: NA, start time:
Nov 10, 2012), combined with:
and developed a serious reaction and side effect(s): Abdominal Pain, Hyperhidrosis, Paraesthesia, Vomiting, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Laevolac treatment in female patients, resulting in Abdominal Pain side effect.
Laevolac Side Effect Report#8190583-0 Liver Disorder
This report suggests a potential LaevolacLiver Disorder side effect(s) that can have serious consequences. A male patient (weight: NA) from Austria was diagnosed with the following symptoms/conditions: NA and used Laevolac (dosage: NA) starting
Mar 01, 2011. After starting Laevolac the patient began experiencing various side effects, including: Liver DisorderAdditional drugs used concurrently:
The patient was hospitalized. Although Laevolac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Disorder, may still occur.
Laevolac Side Effect Report#7799976-4 Osteosclerosis, Prostate Cancer Metastatic, Constipation
This Osteosclerosis problem was reported by a physician from Austria. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation,pain,hypersensitivity,prostate cancer metastatic. On
Mar 24, 2011 this consumer started treatment with Laevolac (dosage: NA). The following drugs were being taken at the same time:
Buprenorphine (As Needed)
When using Laevolac, the patient experienced the following unwanted symptoms/side effects: Osteosclerosis, Prostate Cancer Metastatic, ConstipationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteosclerosis, may become evident only after a product is in use by the general population.
Laevolac Side Effect Report#7716728-1 Arrhythmia, Loss Of Consciousness
This Arrhythmia side effect was reported by a consumer or non-health professional from Italy. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: hepatitis c,tooth infection,myocardial ischaemia,hepatic cirrhosis.The patient was prescribed Laevolac Eps (drug dosage: NA), which was initiated on
Aug 22, 2011. Concurrently used drugs:
Ciproflaxacin (500 Mg, Bid)
Omega-3-acid Ethyl Esters
.After starting to take Laevolac Eps the consumer reported adverse symptoms, such as: Arrhythmia, Loss Of ConsciousnessThese side effects may potentially be related to Laevolac Eps.
The appearance of Laevolac on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Laevolac reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.