· Brand: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate, Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate + 2 more

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Quick answer

Based on 46,000+ FDA adverse event reports, the most-reported dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine reactions include fatigue, nausea, and headache. No active recalls are on record. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

FDA Boxed Warning

WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction ( see WARNINGS and DRUG ABUSE AND DEPENDENCE ).

Common Side Effects of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Fatigue	3,520	7.5%
Nausea	3,162	6.8%
Headache	2,947	6.3%
Anxiety	2,766	5.9%
Depression	2,347	5.0%
Feeling Abnormal	2,214	4.7%
Dizziness	1,928	4.1%
Pain	1,920	4.1%
Somnolence	1,932	4.1%
Insomnia	1,845	3.9%

Source: FDA FAERS·Updated May 28, 2026·n=46,754+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine Recalls

FDA enforcement actions matched to dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

No recalls are on record for this drug in the FDA enforcement database.

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 10 closed recalls (2014 to 2025)

Includes resolved and terminated recalls matched to dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine. Most recent first.

Date	Reason	Class	Quantity	Status
2025-09-17	Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg. Lannett Company Inc.	Class II	4,848 bottles	Resolved
2022-09-21	Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. Teva Pharmaceuticals USA Inc	Class II	83,703 bottles	Terminated
2020-06-10	Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA	Class II	33,280 bottles	Terminated
2020-06-10	Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA	Class II	84,209 bottles	Terminated
2020-06-10	Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA	Class II	41,348 bottles	Terminated
2019-10-23	Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. Aurobindo Pharma USA Inc.	Class II	11,129 100-count bottles	Terminated
2016-01-20	Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. Teva Pharmaceuticals USA	Class II	9,717 bottles	Terminated
2015-08-12	Failed Impurities/Degradation Specifications: out of specification for unknown impurity Teva Pharmaceuticals USA	Class II	19,504 bottles	Terminated
2014-11-05	Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. Teva Pharmaceuticals USA	Class II	19,545 Bottles	Terminated
2014-03-12	CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. Teva Pharmaceuticals USA	Class II	9796 tablets	Terminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine Shortages

FDA-listed shortages of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine products. Strength and dosage-form level detail.

Strength	Reason	Resolved	Status
Adderall, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 57844-115-01)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 42806-345-01)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0555-0777-02)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 42806-341-01)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 72516-016-01)	Delay in shipping of the drug	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 42806-344-01)	Shortage of an active ingredient	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0527-0764-37)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 64850-502-01)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 13107-068-01)	Shortage of an active ingredient	—	Resolved
Adderall, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 57844-130-01)	—	—	Resolved
Adderall, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 57844-105-01)	—	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 70010-116-01)	Shortage of an active ingredient	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 64850-503-01)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 13107-072-01)	Shortage of an active ingredient	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 13107-073-01)	Shortage of an active ingredient	—	Resolved
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 72516-013-01)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 0527-0763-37)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 11534-192-01)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 11534-196-01)	—	—	Resolved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 13107-074-01)	Shortage of an active ingredient	—	Resolved

Source: FDA Drug Shortages·Updated May 28, 2026

Is Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine Safe?

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine is FDA-approved.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine label)·Updated May 28, 2026

FDA-Approved Indications

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine And Amphetamine is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

INDICATIONS AND USAGE Amphetamine sulfate tablets are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.
Show full Indications and UsageSee less
The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. Exogenous Obesity as a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines ( see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.

Source: DailyMed (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine?

Fatigue, nausea, and headache are among the most-reported reactions in FDA FAERS data for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine the same as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate?

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine is the generic name; Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate is a brand name for the same active ingredient. Other brand names include Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate, and Adderall. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine been recalled?

Yes. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine has closed recalls on record in the FDA enforcement database; no recalls are currently active. Reasons are dominated by contamination or foreign material, mislabeling, and subpotent or out-of-spec content. See the recalls table on this page for dates, firm names, and lot quantities.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Is there a current shortage of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine?

No active shortages of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine are listed by the FDA. Historical shortage records appear in the shortages table on this page.

Does dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine have an FDA boxed warning?

Yes. The FDA-approved label for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine and amphetamine carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.