Drug Safety Information for PRIMATENE MIST (Epinephrine)
FDA Safety-related Labeling Changes for EPIPEN (EPINEPHRINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ADRENACLICK (EPINEPHRINE) Discontinued Drug: Safety Information Link
FDA Safety-related Labeling Changes for XYLOCAINE DENTAL WITH EPINEPHRINE (EPINEPHRINE; LIDOCAINE HYDROCHLORIDE) Discontinued Drug: Safety Information Link
FDA Safety-related Labeling Changes for CITANEST FORTE DENTAL (EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for AUVI-Q (EPINEPHRINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ADRENALIN (EPINEPHRINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for SYMJEPI (EPINEPHRINE) Rx Drug: Safety Information Link
Adverse Drug Reactions for PRIMATENE MIST* (Epinephrine)
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 PRIMATENE MIST
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Pain | 829 |
2 | Renal failure | 702 |
3 | Anxiety | 646 |
4 | Drug ineffective | 599 |
5 | Injury | 592 |
6 | Hypotension | 573 |
7 | Dyspnoea | 566 |
8 | Unevaluable event | 521 |
9 | Multi-organ failure | 511 |
10 | Fear | 434 |
11 | Death | 428 |
12 | Emotional distress | 427 |
13 | Product quality issue | 417 |
14 | Accidental exposure | 401 |
15 | Cardiac arrest | 383 |
16 | Renal impairment | 373 |
17 | Nausea | 373 |
18 | Renal injury | 370 |
19 | Stress | 342 |
20 | Headache | 337 |
* This side effect also appears in "Top 10 Side Effects of PRIMATENE MIST " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking PRIMATENE MIST
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 5598 |
2 | Anaphylactic reaction | 1847 |
3 | Hypersensitivity | 1685 |
4 | Hypotension | 802 |
5 | Asthma | 450 |
6 | Arthropod sting | 432 |
7 | Allergy to arthropod sting | 414 |
8 | Food allergy | 396 |
9 | Dyspnoea | 204 |
10 | Cardiac arrest | 181 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for PRIMATENE MIST
Total Reports Filed with FDA: 52413
Number of FDA Adverse Event Reports by Patient Age for PRIMATENE MIST
Total Reports Filed with FDA: 52413*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Epinephrine (Arterenol, Epipen e z pen, Epi e z pen jr, Glaucon, Bronkaid mist, Twinject 0.15, Dopamina, Adrenaclick, Primatene mist, Twinject 0.3, Ephinephrine, Adrenalinum, Auvi-q, Asthmahaler, Racemic epinephrine, Noradrenalin, Epipen jr, Levarterenol, Twinject, Noradrenalina, Vaponefrin, Noradrenaline, Dopamine, Epifrin, Micronefrin, Epipen jr., Adrenalin, Epipen, Epinephrine)
Charts are based on 52413 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.
Click to go back to search results and PRIMATENE MIST Reviews and Review Summary .
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.