Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

XIMINO (NDA-201922)

(MINOCYCLINE HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/29/2026 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

XIMINO is contraindicated in patients with a history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions (5.1)].

5 Warnings and Precautions

5.2 Tooth Discoloration and Enamel Hypoplasia

Subsection title revised

Additions and/or revisions underlined:

The use of tetracycline-class drugs, including XIMINO, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of tetracycline class drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of XIMINO is not recommended during tooth development.

Advise the patient of the potential risk to the fetus if XIMINO is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

5.3 Inhibition of Bone Growth

Subsection title revised

Additions and/or revisions underlined:

The use of tetracycline-class drugs, including XIMINO, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including XIMINO, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Advise the patient of the potential risk to the fetus if XIMINO is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

5.4 Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)

Subsection title revised

. . .

If CDAD is suspected or confirmed, discontinued XIMINO.

5.5 Hepatotoxicity

Additions and/or revisions underlined:

Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Discontinue XIMINO If liver injury is suspected.

5.6 Central Nervous System Effects

Additions and/or revisions underlined:

Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on XIMNO. These symptoms may disappear during therapy and usually rapidly disappear when XIMINO is discontinued.

5.7 Idiopathic Intracranial Hypertension

Subsection title revised

Additions and/or revisions underlined:

Idiopathic Intracranial hypertension has been associated with the use of tetracycline-class drugs, including XIMINO. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy.

Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and XIMINO because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension.

Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize.

5.8 Autoimmune Syndromes

Additions and/or revisions underlined:

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis, and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Evaluate symptomatic patients. If symptoms occur, immediately discontinue use of XIMINO.

5.9 Metabolic Effects

Additions and/or revisions underlined:

The anti-anabolic action of the tetracyclines, including XIMINO, may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, lower the total doses of XIMINO, and if therapy is prolonged, monitor serum levels of XIMINO.

5.10 Photosensitivity

Additions and/or revisions underlined:

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (e.g., tanning beds or UVA/B treatment) while using XIMINO. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions (5.4)]
Hepatotoxicity [see Warnings and Precautions (5.5)]
Central Nervous System Effects [see Warnings and Precautions (5.6)]
Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of greater than or equal to 1% for XIMINO and higher than placebo.

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects and Higher than Placebo

. . .

6.2 Postmarketing Experience

Additions and/or revisions underlined:

. . .

Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome.

Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing.

. . .

7 Drug Interactions

7.2 Penicillin

Additions and/or revisions underlined:

Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving XIMINO in conjunction with penicillin.

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion

Additions and/or revisions underlined:

Risk Summary

Tetracycline-class drugs, including XIMINO, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.4)]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data).

If a patient becomes pregnant while taking XIMINO, advise the patient of the risk to the fetus and to discontinue treatment.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Human Data

The use of tetracycline-class drugs, including XIMINO, during tooth development (second and third trimesters, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2)].

Animal Data

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3)].

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (3 and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

8.2 Lactation

PLLR Conversion

Additions and/or revisions underlined:

Risk Summary

Tetracycline-class antibiotics, including minocycline, are present in human milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with XIMINO and for 4 days after the final dose [see Warnings and Precautions (5.2, 5.3)].

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of XIMINO have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Clinical Studies (14)]. Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution (5.2, 5.3)]. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions (5.2)].

Safety and effectiveness of XIMINO have not been established in pediatric patients younger than 12 years of age.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking XIMINO should receive the following information and instructions:

Administration Instructions

XIMINO should be taken exactly as directed.
Advise patients to swallow XIMINO whole and not to chew, crush, or split the capsules [see Dosage and Administration (2)].

Serious Skin/Hypersensitivity Reactions

Inform patients that serious skin reactions have occurred with the minocycline use in patients with acne. Advise patients to discontinue use of XIMINO and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions (5.1)].

Tooth Discoloration and Enamel Hypoplasia

Advise patients that XIMINO use in pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise patients to discontinue XIMINO during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.2), Use in Specific Populations (8.1)].
Advise caregivers of pediatric patients that XIMINO use may cause permanent discoloration of deciduous and permanent teeth [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].

Inhibition of Bone Growth

Advise patients that XIMINO use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue XIMINO during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)].

Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)

Advise patients that Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including XIMINO. If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions (5.4)].

Hepatotoxicity

Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness [see Warnings and Precautions (5.5)].

Central Nervous System Effects

Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on XIMINO [see Warnings and Precautions (5.6)].

Idiopathic Intracranial Hypertension

Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions (5.7)].

Autoimmune Syndromes

Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise. Advise patients who experience such symptoms to immediately discontinue XIMINO and seek medical help [see Warnings and Precautions (5.8)].

Photosensitivity

Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using XIMINO. Instruct patients to use sunscreen and wear protective clothing (e.g., hat) when exposure to sun cannot be avoided [see Warnings and Precautions (5.10)].

Tissue Hyperpigmentation

Inform patients that XIMINO may cause discoloration of skin, scars, teeth, or gums [see Warnings and Precautions (5.11)].

Lactation

Advise patients that XIMINO therapy is not recommended during breastfeeding and for 4 days after the final dose [see Use in Specific Populations (8.2)].

PATIENT INFORMATION

Extensive changes; please refer to label for complete information.