What are the possible side effects of Percoffedrinol N?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Percoffedrinol N and call your doctor if you have:
-
ongoing tiredness or drowsiness; or
-
ongoing sleep problems.
Common side effects may include:
-
feeling restless;
-
loss of appetite; or
-
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Percoffedrinol N side effects (more detail)
Side effects of Percoffedrinol N in details
Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Percoffedrinol N Citrate and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Percoffedrinol N Citrate-treated patients than placebo.
| Adverse Event (AE) | Percoffedrinol N Citrate N=46 n (%) | Placebo N=39 n (%) |
| BODY AS A WHOLE | ||
| Accidental Injury | 1 (2.2) | 0 (0) |
| Feeding Intolerance | 4 (8.7) | 2 (5.1) |
| Sepsis | 2 (4.3) | 0 (0) |
| CARDIOVASCULAR SYSTEM | ||
| Hemorrhage | 1 (2.2) | 0 (0) |
| DIGESTIVE SYSTEM | ||
| Necrotizing Enterocolitis | 2 (4.3) | 1 (2.6) |
| Gastritis | 1 (2.2) | 0 (0) |
| Gastrointestinal Hemorrhage | 1 (2.2) | 0 (0) |
| HEMIC AND LYMPHATIC SYSTEM | ||
| Disseminated Intravascular Coagulation | 1 (2.2) | 0 (0) |
| METABOLIC AND NUTRITIVE DISORDERS | ||
| Acidosis | 1 (2.2) | 0 (0) |
| Healing Abnormal | 1 (2.2) | 0 (0) |
| NERVOUS SYSTEM | ||
| Cerebral Hemorrhage | 1 (2.2) | 0 (0) |
| RESPIRATORY SYSTEM | ||
| Dyspnea | 1 (2.2) | 0 (0) |
| Lung Edema | 1 (2.2) | 0 (0) |
| SKIN AND APPENDAGES | ||
| Dry Skin | 1 (2.2) | 0 (0) |
| Rash | 4 (8.7) | 3 (7.7) |
| Skin Breakdown | 1 (2.2) | 0 (0) |
| SPECIAL SENSES | ||
| Retinopathy of Prematurity | 1 (2.2) | 0 (0) |
| UROGENITAL SYSTEM | ||
| Kidney Failure | 1 (2.2) | 0 (0) |
In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Percoffedrinol N Citrate during the open-label phase of the study.
Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to Percoffedrinol N. Two were randomized to Percoffedrinol N, and one placebo patient was “rescued” with open-label Percoffedrinol N for uncontrolled apnea.
Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (i.e., hypoglycemia and hyperglycemia), and renal effects (i.e., increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown Percoffedrinol N to adversely affect neurological development or growth parameters.
What is the most important information I should know about Percoffedrinol N?
- Percoffedrinol N may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Percoffedrinol N. Using Percoffedrinol N alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Avoid large amounts of Percoffedrinol N-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. This includes any medicines that contain Percoffedrinol N.
- Percoffedrinol N is not to be used as a substitute for sleep.
- Diabetes patients - Percoffedrinol N may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Percoffedrinol N is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Percoffedrinol N, discuss with your doctor the benefits and risks of using Percoffedrinol N during pregnancy. It is unknown if Percoffedrinol N is excreted in breast milk. If you are or will be breast-feeding while you are using Percoffedrinol N, check with your doctor or pharmacist to discuss the risks to your baby.
When used for long periods of time or at high doses, some people develop a need to continue taking Percoffedrinol N. This is known as DEPENDENCE or addiction.
If you suddenly stop taking Percoffedrinol N, you may experience WITHDRAWAL symptoms including dizziness, headache, unusual tiredness, irritability, muscle tension, or nausea.
Percoffedrinol N contraindications
Percoffedrinol N citrate should not be given to a child who has had an allergic reaction to it in the past.
Before using Percoffedrinol N citrate, tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.
Do not use the medication for longer than 12 days without the advice of your child's doctor.
Each bottle of Percoffedrinol N citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.
Call your doctor if the child's breathing symptoms do not improve after using Percoffedrinol N citrate.
To be sure Percoffedrinol N citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
References
- DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "caffeine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Caffeine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Percoffedrinol N are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Percoffedrinol N. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
