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Two medicines, side by side

Acetaminophen vs amitriptyline

Acetaminophen is labeled for fever, cough and cold and pain; amitriptyline for depression. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of acetaminophen since 1968 and of amitriptyline since 1961. Pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet) and $0.03 per amitriptyline HCl 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the acetaminophen FDA label on DailyMed (effective November 13, 2024); the amitriptyline FDA label on DailyMed (effective September 8, 2026).

Highlights of the acetaminophen record

Acetaminophen (Tylenol) · label of November 13, 2024

Used for

From the label: indications

temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

On the market

Earliest approval on file
November 7, 1968
Generic labelers
89 labelers
Pharmacy cost
$0.0339 per unit

Supply and safety

Shortage
No current entry
Recalls
19

Highlights of the amitriptyline record

Amitriptyline (Elavil) · label of September 8, 2026

Boxed warning

Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

Used for

From the label: indications

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

On the market

Earliest approval on file
April 7, 1961
Generic labelers
34 labelers
Pharmacy cost
$0.03 per tablet

Supply and safety

Shortage
No current entry
Recalls
2

Source: FDA drug labels via openFDA (Acetaminophen label of November 13, 2024, Amitriptyline label of September 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do acetaminophen and amitriptyline differ on the record?

Both labels carry a boxed warning; the records quote them.

Generics: acetaminophen since 1986; amitriptyline since 1976 (Drugs@FDA).

AcetaminophenAmitriptyline
Labeled forFever, Cough and cold, PainDepression
Pharmacologic classn/aTricyclic Antidepressant
How it works (label)n/ain man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)November 7, 1968April 7, 1961
First generic approvedDecember 1, 1986November 16, 1976
Generic labelers (NDC)89 labelers34 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0339 per unit (Acetaminophen 500 mg caplet)$0.03 per tablet (Amitriptyline HCl 10 mg tablet)
12-month price change+5%-19%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded192
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)445,07517,441
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What do the labels say about using others of their kind?

Amitriptyline label, warnings

If concomitant use of amitriptyline hydrochloride with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Source: FDA drug labels via openFDA

What next?

Alternatives to acetaminophen
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