Drug Safety Information for POTASSIUM CHLORIDE (Potassium chloride)
Safety-related Labeling Changes for POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% (POTASSIUM CHLORIDE; SODIUM CHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE) Discontinued Drug: FDA Link
Safety-related Labeling Changes for MICRO-K (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for K-TAB (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for KLOR-CON (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Safety-related Labeling Changes for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER (POTASSIUM CHLORIDE) Rx Drug: FDA Link
Adverse Drug Reactions for POTASSIUM CHLORIDE* (Potassium chloride)
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 POTASSIUM CHLORIDE
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Dyspnoea | 3446 |
| 2 | Nausea* | 2967 |
| 3 | Diarrhoea* | 2402 |
| 4 | Fatigue | 2345 |
| 5 | Asthenia | 2322 |
| 6 | Pain | 2102 |
| 7 | Vomiting* | 1975 |
| 8 | Pneumonia | 1970 |
| 9 | Dizziness | 1951 |
| 10 | Oedema peripheral | 1914 |
| 11 | Cardiac failure congestive | 1896 |
| 12 | Fall | 1788 |
| 13 | Anaemia | 1760 |
| 14 | Headache | 1596 |
| 15 | Hypotension | 1564 |
| 16 | Death | 1530 |
| 17 | Chest pain | 1506 |
| 18 | Drug ineffective* | 1479 |
| 19 | Pyrexia | 1479 |
| 20 | Renal failure acute | 1338 |
* This side effect also appears in "Top 10 Side Effects of POTASSIUM CHLORIDE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking POTASSIUM CHLORIDE
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Product used for unknown indication | 22923 |
| 2 | Hypokalaemia | 4284 |
| 3 | Mineral supplementation | 3878 |
| 4 | Blood potassium decreased | 3188 |
| 5 | Electrolyte substitution therapy | 1753 |
| 6 | Supplementation therapy | 1435 |
| 7 | Prophylaxis | 1090 |
| 8 | Hypertension | 1009 |
| 9 | Blood potassium | 965 |
| 10 | Muscle spasms | 467 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for POTASSIUM CHLORIDE
Total Reports Filed with FDA: 248553
Number of FDA Adverse Event Reports by Patient Age for POTASSIUM CHLORIDE
Total Reports Filed with FDA: 248553*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Potassium chloride (K-lease, Kaon cl-10, Micro-k ls, Ten-k, Kloref, Epiklor, K+8, Cena-k, Epiklor/25, Micro-k 10 extencaps, Klor con m, Klotrix, Klor-con m, Klor-con m15, Kali muriaticum, Kaochlor, Kaon cl, K-lor, Micro-k extencaps, K-dur 20, K+10, Klorvess, K-dur, Slow-k, Potassium chloride, Micro-k 10, K-tab, Klor-con, Micro-k, Klor-con m10, Klor-con m20)
Charts are based on 248553 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.