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What the FDA labels say about taking them together

Clomipramine and fentanyl

Clomipramine's FDA label of November 26, 2024 names fentanyl in its warnings section; fentanyl's label does not name clomipramine itself but warns about its class (Tricyclic antidepressants). The clomipramine label: “Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including clomipramine hydrochloride capsules, alone but particularly with concomitant use …”

Check it at the source: the clomipramine FDA label on DailyMed (effective November 26, 2024); the fentanyl FDA label on DailyMed (effective March 6, 2026, Hikma Pharmaceuticals USA Inc.).

What does the clomipramine label say about fentanyl?

Clomipramine label, warnings

Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including clomipramine hydrochloride capsules, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Source: FDA drug label (CLOMIPRAMINE HYDROCHLORIDE), SpecGx LLC, effective November 26, 2024 (SPL set d7cee3fa-d05c-4702-8f75-f446627bdb49), via openFDA; the full label on DailyMed

What does the fentanyl label say about clomipramine?

Fentanyl's label does not name clomipramine itself; it warns about its class (Tricyclic antidepressants):

Fentanyl label, warnings and precautions

If ‎a patient is suspected to be experiencing OIH, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or opioid rotation (safely ‎switching the patient to a different opioid moiety) [see Dosage and ‎Administration (2), Warnings and Precautions (5.7) ] .‎ 5.8 Serotonin Syndrome with Concomitant Use of Serotonergic Drugs Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of fentanyl with serotonergic drugs. …

Fentanyl label, warnings and precautions

Syndrome with Concomitant Use of Serotonergic Drugs Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of fentanyl with serotonergic drugs. Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazadone, tramadol), certain …

Source: FDA drug label (Fentanyl Citrate), Hikma Pharmaceuticals USA Inc., effective March 6, 2026 (SPL set ce5db1c2-feb1-4ad2-847a-d02e865bd47e), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

16Clomipramine generic labelers
6Fentanyl generic labelers
ClomipramineFentanyl
Labeled forn/aPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.189 per capsule 25 mg capsule$1.79 per mL 100 mcg/2 mL vial
Shortage nowNo current entryIn shortage

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

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