What are the possible side effects of Uphamol 650?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, Uphamol 650 may cause a severe skin reaction that can be fatal. This could occur even if you have taken Uphamol 650 in the past and had no reaction. Stop using this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains Acetaminophen.
Stop using Uphamol 650 and call your doctor at once if you have:
-
chest pain, trouble breathing; or
-
liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
-
vomiting;
-
constipation;
-
feeling agitated;
-
headache; 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.
Side effects of Uphamol 650 in details
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hepatic Injury
- Serious Skin Reactions
- Allergy and Hypersensitivity
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
Adult Population
A total of 1,020 adult patients have received Uphamol 650 in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with Uphamol 650 1,000 mg every 6 hours. A total of 13.1% (n=134) received Uphamol 650 650 mg every 4 hours.
All adverse reactions that occurred in adult patients treated with either Uphamol 650 or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 4. The most common adverse events in adult patients treated with Uphamol 650 (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.
* Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Uphamol 650 may mask fever. | ||
System Organ Class – Preferred Term | Uphamol 650 (N=402) n (%) | Placebo (N=379) n (%) |
Gastrointestinal Disorders Nausea Vomiting | 138 (34) 62 (15) | 119 (31) 42 (11) |
General Disorders and Administration Site Conditions Pyrexia* | 22 (5) | 52 (14) |
Nervous System Disorders Headache | 39 (10) | 33 (9) |
Psychiatric Disorders Insomnia | 30 (7) | 21 (5) |
Other Adverse Reactions Observed During Clinical Studies of Uphamol 650 in Adults
The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Uphamol 650 in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).
Blood and lymphatic system disorders: anemia
General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral
Investigations: aspartate aminotransferase increased, breath sounds abnormal
Metabolism and nutrition disorders: hypokalemia
Musculoskeletal and connective tissue disorders: muscle spasms, trismus
Psychiatric disorders: anxiety
Respiratory, thoracic and mediastinal disorders: dyspnea
Vascular disorders: hypertension, hypotension
Pediatric Population
A total of 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received Uphamol 650 in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses. Pediatric patients received Uphamol 650 doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.
The most common adverse events (incidence ≥ 5%) in pediatric patients treated with Uphamol 650 were nausea, vomiting, constipation, and pruritus.
Other Adverse Reactions Observed During Clinical Studies of Uphamol 650 in Pediatrics
The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Uphamol 650 (n=483) that occurred with an incidence of at least 1%.
Blood and lymphatic system disorders: anemia
Gastrointestinal disorders: diarrhea
General disorders and administration site conditions: pyrexia, injection site pain
Metabolism and nutrition disorders: hypokalemia, hypomagnesemia, hypoalbuminemia, hypophosphatemia
Musculoskeletal and connective tissue disorders: muscle spasm
Nervous system disorders: headache
Psychiatric disorders: agitation
Renal and urinary disorders: oliguria
Respiratory, thoracic and mediastinal disorders: atelectasis, pleural effusion, pulmonary edema, stridor, wheezing
Vascular disorders: hypotension, hypertension
What is the most important information I should know about Uphamol 650?
- Uphamol 650 injection has Uphamol 650 in it. Before you start any new medicine, check the label to see if it has Uphamol 650 in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Uphamol 650 injection may harm your liver. Your risk may be greater if you drink alcohol while you are using Uphamol 650 injection or if you use Uphamol 650 injection in high doses. Talk to your doctor before you use Uphamol 650 injection or other fever reducers if you drink more than 3 drinks with alcohol per day. Do NOT use more than the recommended dose without checking with your doctor.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Uphamol 650 injection should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Uphamol 650 injection while you are pregnant. Uphamol 650 injection is found in breast milk. If you are or will be breast-feeding while you use Uphamol 650 injection, check with your doctor. Discuss any possible risks to your baby.
Uphamol 650 contraindications
There are many brands and forms of Uphamol 650 available and not all brands are listed on this leaflet.
Do not take more of this medication than is recommended. An overdose of Uphamol 650 can damage your liver or cause death.
Know the amount of Uphamol 650 in the specific product you are taking.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Uphamol 650.
Avoid drinking alcohol. It may increase your risk of liver damage while taking Uphamol 650.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Uphamol 650 (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Uphamol 650 which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen or APAP.
References
- DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: 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. "acetaminophen: 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. "Paracetamol: 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 Uphamol 650 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 Uphamol 650. 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
5 consumers reported side effects
Did you experience side effects while taking Uphamol 650 drug?According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Uphamol 650 drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users | % | ||
---|---|---|---|
No side effects | 4 | 80.0% | |
It has side effects | 1 | 20.0% |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology