Drug Safety Information for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate)
FDA Safety-related Labeling Changes for ADDERALL 10 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ADDERALL XR 10 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) Rx Drug: Safety Information Link
Adverse Drug Reactions for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE* (Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate)
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 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug ineffective | 874 |
2 | Fatigue | 717 |
3 | Nausea | 631 |
4 | Headache* | 624 |
5 | Depression* | 573 |
6 | Anxiety* | 563 |
7 | Pain | 503 |
8 | Insomnia* | 485 |
9 | Dizziness | 425 |
10 | Feeling abnormal | 386 |
11 | Overdose | 375 |
12 | Product quality issue | 345 |
13 | Dyspnoea | 320 |
14 | Somnolence | 315 |
15 | Product substitution issue | 307 |
16 | Weight increased | 304 |
17 | Vomiting | 295 |
18 | Weight decreased* | 294 |
19 | Suicidal ideation | 286 |
20 | Aggression | 275 |
* This side effect also appears in "Top 10 Side Effects of DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Attention deficit/hyperactivity disorder* | 11118 |
2 | Product used for unknown indication | 4526 |
3 | Fatigue* | 826 |
4 | Narcolepsy* | 444 |
5 | Depression* | 420 |
6 | Disturbance in attention | 345 |
7 | Asthenia | 132 |
8 | Somnolence | 119 |
9 | Sleep disorder | 108 |
10 | Anxiety | 108 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Total Reports Filed with FDA: 43710
Number of FDA Adverse Event Reports by Patient Age for DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Total Reports Filed with FDA: 43710*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate (Adderall 10, Adderall, Adderall xr 25, Adderall 30, Adderall 20, Adderall xr 30, Adderall 15, Adderall xr 10, Adderall xr, Adderall 12.5, Adderall xr 15, Adderall 7.5, Adderall xr 5, Adderall 5, Adderall xr 20)
Charts are based on 43710 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.