Drug Safety Information for PREMASOL 6% IN PLASTIC CONTAINER (Amino acids)

Safety-related Labeling Changes for TRAVASOL 10% IN PLASTIC CONTAINER (AMINO ACIDS) Rx Drug: FDA Link

Safety-related Labeling Changes for CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER (AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM AC) Rx Drug: FDA Link

Safety-related Labeling Changes for CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER (AMINO ACIDS; DEXTROSE) Rx Drug: FDA Link

Safety-related Labeling Changes for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER (AMINO ACIDS) Rx Drug: FDA Link

Safety-related Labeling Changes for KABIVEN IN PLASTIC CONTAINER (AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODI) Rx Drug: FDA Link

Safety-related Labeling Changes for PERIKABIVEN IN PLASTIC CONTAINER (AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODI) Rx Drug: FDA Link

Adverse Drug Reactions for PREMASOL 6% IN PLASTIC CONTAINER* (Amino acids)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PREMASOL 6% IN PLASTIC CONTAINER
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea297
2Femur fracture268
3Drug ineffective268
4Fall255
5Fatigue250
6Pain245
7Anxiety238
8Headache238
9Depression226
10Dyspnoea225
11Arthralgia210
12Weight increased205
13Osteoarthritis197
14Dizziness196
15Hypertension195
16Pain in extremity186
17Insomnia183
18Diarrhoea170
19Back pain168
20Vomiting166

* This side effect also appears in "Top 10 Side Effects of PREMASOL 6% IN PLASTIC CONTAINER " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PREMASOL 6% IN PLASTIC CONTAINER
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2291
2Hormone replacement therapy1452
3Menopause485
4Osteoporosis278
5Hormone therapy185
6Hyperlipidaemia169
7Prostate cancer149
8Breast cancer92
9Blood cholesterol increased91
10Medical diet80

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PREMASOL 6% IN PLASTIC CONTAINER

Total Reports Filed with FDA: 30778


Number of FDA Adverse Event Reports by Patient Age for PREMASOL 6% IN PLASTIC CONTAINER

Total Reports Filed with FDA: 30778*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amino acids (Aminosyn 10% (ph6), Aminosyn 5%, Freamine ii 8.5%, Branchamin 4%, Aminosyn-pf 7%, Carbohydrate, Aminosyn ii 5%, Phospholipid, Aminosyn ii 10%, Freamine hbc 6.9%, Aminosyn-rf 5.2%, Novamine 11.4%, Freamine iii 10%, Trophamine 10%, Aminosyn 7% (ph6), Aminosyn 7%, Aminosyn 3.5%, Aminosyn 8.5% (ph6), Aminosyn-pf 10%, Neopham 6.4%, Aminosyn ii 3.5%, Novamine 8.5%, Hepatasol 8%, Aminosyn-hbc 7%, Freamine iii 8.5%, Freamine 8.5%, Lipids, Aminosyn-hf 8%, Aminosyn ii 7%, Amino acids, Aminosyn 8.5%, Fatty acids, Hormone, Hormones, Lipid, Sugar, Trophamine, Glycosaminoglycan, Aminosyn 10%, Ribonucleic acid, Phospholipids, Protein, Nephramine 5.4%, Aminosyn ii 8.5%, Pyrimidine, Novamine 15%, Hepatamine 8%, Carbohydrates, Fatty acid)

Charts are based on 30778 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.